Trial Outcomes & Findings for A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC) (NCT NCT02763579)
NCT ID: NCT02763579
Last Updated: 2023-07-28
Results Overview
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least 20% increase in the sum of the longest diameter of target lesions compared to baseline, or unequivocal progression in non-target lesion(s), or the appearance of new lesion(s).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
503 participants
Primary outcome timeframe
Baseline until PD or death, whichever occurs first (up to approximately 23 months)
Results posted on
2023-07-28
Participant Flow
Participants were enrolled at 114 centers in 21 countries: United States of America, Poland, Japan, Russia, Spain, Austria, Hungary, Czech Republic, South Korea, Italy, Serbia, Australia, Greece, United Kingdom, Germany, Taiwan, France, Chile, Brazil, Mexico, and China.
The total study population included 503 participants. The Global population included 403 participants. An additional 100 participants enrolled during the China Extension. The total China population included 10 Chinese participants from the Global population plus 100 participants from the China extension. 10 participants were part of the Global as well as China populations. Separate analyses were performed for the Global population and the China population in the study.
Participant milestones
| Measure |
Placebo + Carboplatin + Etoposide - Global
Participants in the Global population received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide - Global
Participants in the Global population received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Placebo + Carboplatin + Etoposide - China
Participants in the China population received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide - China
Participants in the China population received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
|---|---|---|---|---|
|
Global Period
STARTED
|
202
|
201
|
0
|
0
|
|
Global Period
COMPLETED
|
0
|
0
|
0
|
0
|
|
Global Period
NOT COMPLETED
|
202
|
201
|
0
|
0
|
|
China Period
STARTED
|
0
|
0
|
53
|
57
|
|
China Period
COMPLETED
|
0
|
0
|
0
|
0
|
|
China Period
NOT COMPLETED
|
0
|
0
|
53
|
57
|
Reasons for withdrawal
| Measure |
Placebo + Carboplatin + Etoposide - Global
Participants in the Global population received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide - Global
Participants in the Global population received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Placebo + Carboplatin + Etoposide - China
Participants in the China population received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide - China
Participants in the China population received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
|---|---|---|---|---|
|
Global Period
Death
|
167
|
151
|
0
|
0
|
|
Global Period
Lost to Follow-up
|
2
|
4
|
0
|
0
|
|
Global Period
Physician Decision
|
0
|
2
|
0
|
0
|
|
Global Period
Study Terminated By Sponsor
|
21
|
26
|
0
|
0
|
|
Global Period
Withdrawal by Subject
|
12
|
18
|
0
|
0
|
|
China Period
Death
|
0
|
0
|
46
|
48
|
|
China Period
Lost to Follow-up
|
0
|
0
|
1
|
1
|
|
China Period
Physician Decision
|
0
|
0
|
0
|
1
|
|
China Period
Study Terminated By Sponsor
|
0
|
0
|
3
|
4
|
|
China Period
Withdrawal by Subject
|
0
|
0
|
3
|
3
|
Baseline Characteristics
The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
Baseline characteristics by cohort
| Measure |
Placebo + Carboplatin + Etoposide - All
n=251 Participants
All participants in the Global or China population received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide - All
n=252 Participants
All participants in the Global or China population received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Total
n=503 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Global
|
63.6 years
STANDARD_DEVIATION 9.0 • n=202 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
63.8 years
STANDARD_DEVIATION 8.8 • n=201 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
63.7 years
STANDARD_DEVIATION 8.9 • n=403 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Age, Continuous
China
|
60.7 years
STANDARD_DEVIATION 8.8 • n=53 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
59.7 years
STANDARD_DEVIATION 9.0 • n=57 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
60.2 years
STANDARD_DEVIATION 8.9 • n=110 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Sex: Female, Male
Global · Female
|
70 Participants
n=202 Participants • The Global population included 403 participants. The China population included 100 participants enrolled during the China Extension plus 10 Chinese participants from the Global population.
|
72 Participants
n=201 Participants • The Global population included 403 participants. The China population included 100 participants enrolled during the China Extension plus 10 Chinese participants from the Global population.
|
142 Participants
n=403 Participants • The Global population included 403 participants. The China population included 100 participants enrolled during the China Extension plus 10 Chinese participants from the Global population.
|
|
Sex: Female, Male
Global · Male
|
132 Participants
n=202 Participants • The Global population included 403 participants. The China population included 100 participants enrolled during the China Extension plus 10 Chinese participants from the Global population.
|
129 Participants
n=201 Participants • The Global population included 403 participants. The China population included 100 participants enrolled during the China Extension plus 10 Chinese participants from the Global population.
|
261 Participants
n=403 Participants • The Global population included 403 participants. The China population included 100 participants enrolled during the China Extension plus 10 Chinese participants from the Global population.
|
|
Sex: Female, Male
China · Female
|
12 Participants
n=53 Participants • The Global population included 403 participants. The China population included 100 participants enrolled during the China Extension plus 10 Chinese participants from the Global population.
|
11 Participants
n=57 Participants • The Global population included 403 participants. The China population included 100 participants enrolled during the China Extension plus 10 Chinese participants from the Global population.
|
23 Participants
n=110 Participants • The Global population included 403 participants. The China population included 100 participants enrolled during the China Extension plus 10 Chinese participants from the Global population.
|
|
Sex: Female, Male
China · Male
|
41 Participants
n=53 Participants • The Global population included 403 participants. The China population included 100 participants enrolled during the China Extension plus 10 Chinese participants from the Global population.
|
46 Participants
n=57 Participants • The Global population included 403 participants. The China population included 100 participants enrolled during the China Extension plus 10 Chinese participants from the Global population.
|
87 Participants
n=110 Participants • The Global population included 403 participants. The China population included 100 participants enrolled during the China Extension plus 10 Chinese participants from the Global population.
|
|
Ethnicity (NIH/OMB)
Global · Hispanic or Latino
|
8 Participants
n=202 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
8 Participants
n=201 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
16 Participants
n=403 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Ethnicity (NIH/OMB)
Global · Not Hispanic or Latino
|
185 Participants
n=202 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
187 Participants
n=201 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
372 Participants
n=403 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Ethnicity (NIH/OMB)
Global · Unknown or Not Reported
|
9 Participants
n=202 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
6 Participants
n=201 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
15 Participants
n=403 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Ethnicity (NIH/OMB)
China · Hispanic or Latino
|
0 Participants
n=53 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=57 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=110 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Ethnicity (NIH/OMB)
China · Not Hispanic or Latino
|
53 Participants
n=53 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
57 Participants
n=57 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
110 Participants
n=110 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Ethnicity (NIH/OMB)
China · Unknown or Not Reported
|
0 Participants
n=53 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=57 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=110 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Race (NIH/OMB)
Global · American Indian or Alaska Native
|
1 Participants
n=202 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=201 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
1 Participants
n=403 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Race (NIH/OMB)
Global · Asian
|
36 Participants
n=202 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
33 Participants
n=201 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
69 Participants
n=403 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Race (NIH/OMB)
Global · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=201 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=403 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Race (NIH/OMB)
Global · Black or African American
|
2 Participants
n=202 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
1 Participants
n=201 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
3 Participants
n=403 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Race (NIH/OMB)
Global · White
|
159 Participants
n=202 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
163 Participants
n=201 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
322 Participants
n=403 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Race (NIH/OMB)
Global · More than one race
|
0 Participants
n=202 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=201 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=403 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Race (NIH/OMB)
Global · Unknown or Not Reported
|
4 Participants
n=202 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
4 Participants
n=201 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
8 Participants
n=403 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Race (NIH/OMB)
China · American Indian or Alaska Native
|
0 Participants
n=53 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=57 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=110 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Race (NIH/OMB)
China · Asian
|
53 Participants
n=53 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
57 Participants
n=57 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
110 Participants
n=110 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Race (NIH/OMB)
China · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=53 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=57 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=110 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Race (NIH/OMB)
China · Black or African American
|
0 Participants
n=53 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=57 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=110 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Race (NIH/OMB)
China · White
|
0 Participants
n=53 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=57 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=110 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Race (NIH/OMB)
China · More than one race
|
0 Participants
n=53 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=57 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=110 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
|
Race (NIH/OMB)
China · Unknown or Not Reported
|
0 Participants
n=53 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=57 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
0 Participants
n=110 Participants • The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
|
PRIMARY outcome
Timeframe: Baseline until PD or death, whichever occurs first (up to approximately 23 months)Population: The ITT population was defined as all randomized participants, regardless of whether the participant received the assigned treatment.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least 20% increase in the sum of the longest diameter of target lesions compared to baseline, or unequivocal progression in non-target lesion(s), or the appearance of new lesion(s).
Outcome measures
| Measure |
Placebo + Carboplatin + Etoposide
n=202 Participants
Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide
n=201 Participants
Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
|---|---|---|
|
Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
|
4.3 Months
95% Confidence Interval 4.2 • Interval 4.2 to 4.5
|
5.2 Months
95% Confidence Interval 4.4 • Interval 4.4 to 5.6
|
PRIMARY outcome
Timeframe: Baseline until death from any cause (up to approximately 23 months)Population: The ITT population was defined as all randomized participants, regardless of whether the participant received the assigned treatment.
OS is defined as the time from randomization to death from any cause.
Outcome measures
| Measure |
Placebo + Carboplatin + Etoposide
n=202 Participants
Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide
n=201 Participants
Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
|---|---|---|
|
Duration of Overall Survival (OS) in the Global Population
|
10.3 Months
95% Confidence Interval 9.3 • Interval 9.3 to 11.3
|
12.3 Months
95% Confidence Interval 10.8 • Interval 10.8 to 15.9
|
SECONDARY outcome
Timeframe: Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to approximately 23 months)Population: The ITT population was defined as all randomized participants, regardless of whether the participant received the assigned treatment.
Objective response (OR) is defined as complete response (CR) or partial response (PR) as determined by the investigator according to RECIST v1.1.
Outcome measures
| Measure |
Placebo + Carboplatin + Etoposide
n=202 Participants
Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide
n=201 Participants
Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
|---|---|---|
|
Percentage of Participants With Objective Response Rate (ORR) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
|
76.7 Percentage of participants
Interval 70.29 to 82.38
|
74.1 Percentage of participants
Interval 67.5 to 80.03
|
SECONDARY outcome
Timeframe: First occurrence of PR or CR until PD or death, whichever occurs first (up to approximately 23 months)Population: The ITT population was defined as all randomized participants, regardless of whether the participant received the assigned treatment.
DOR is defined as the time interval from first occurrence of a documented objective response to the time of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever comes first.
Outcome measures
| Measure |
Placebo + Carboplatin + Etoposide
n=155 Participants
Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide
n=149 Participants
Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
|---|---|---|
|
Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
|
3.1 Months
Interval 2.9 to 3.9
|
4.1 Months
Interval 3.5 to 4.2
|
SECONDARY outcome
Timeframe: 6 months, 1 yearPopulation: The ITT population was defined as all randomized participants, regardless of whether the participant received the assigned treatment.
PFS rates at 6 months and at 1 year is defined as the proportion of participants who are alive without disease progression 6 months and 1 year after randomization, respectively.
Outcome measures
| Measure |
Placebo + Carboplatin + Etoposide
n=202 Participants
Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide
n=201 Participants
Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
|---|---|---|
|
PFS Rate at 6 Months and at 1 Year in Global Population
6 Months
|
22.39 Percentage of participants
Interval 16.56 to 28.22
|
30.86 Percentage of participants
Interval 24.26 to 37.45
|
|
PFS Rate at 6 Months and at 1 Year in Global Population
1 Year
|
5.35 Percentage of participants
Interval 2.14 to 8.56
|
12.62 Percentage of participants
Interval 7.85 to 17.4
|
SECONDARY outcome
Timeframe: 1 year, 2 yearsPopulation: The ITT population was defined as all randomized participants, regardless of whether the participant received the assigned treatment.
OS rates at 1 and 2 years is defined as the proportion of participants who are alive 1 year and 2 years after randomization, respectively.
Outcome measures
| Measure |
Placebo + Carboplatin + Etoposide
n=202 Participants
Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide
n=201 Participants
Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
|---|---|---|
|
OS Rate at 1 Year and 2 Years in the Global Population
1 Year
|
38.23 Percentage of participants
|
51.69 Percentage of participants
|
|
OS Rate at 1 Year and 2 Years in the Global Population
2 Years
|
NA Percentage of participants
Insufficient number of participants with events.
|
NA Percentage of participants
Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline until deterioration per symptom subscale (up to approximately 23 months)Population: The ITT population was defined as all randomized participants, regardless of whether the participant received the assigned treatment.
TTD according to the EORTC QLQ-C30 and EORTC QLQ-LC13 measures were evaluated in each of the following linearly transformed symptom scores: cough, dyspnea (single item), dyspnea (multi-item subscale), chest pain, or arm/shoulder pain. The linear transformation gives each individual symptom subscale a possible score of 0 to 100. For the symptom to be considered "deteriorated," a score increase of ≥10 points above baseline must be held for at least two consecutive assessments or an initial score increase of ≥10 points is followed by death within 3 weeks from the last assessment. A ≥ 10-point change in the symptoms subscale score is perceived by participants as clinically significant.
Outcome measures
| Measure |
Placebo + Carboplatin + Etoposide
n=202 Participants
Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide
n=201 Participants
Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
|---|---|---|
|
Time to Deterioration (TTD) Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30) and Supplemental Lung Cancer Module (QLQ-LC13) in the Global Population
Cough
|
NA Month
Interval 16.6 to
Insufficient number of participants with events.
|
20.3 Month
Insufficient number of participants with events.
|
|
Time to Deterioration (TTD) Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30) and Supplemental Lung Cancer Module (QLQ-LC13) in the Global Population
Pain in Chest
|
NA Month
Interval 10.9 to
Insufficient number of participants with events.
|
NA Month
Insufficient number of participants with events.
|
|
Time to Deterioration (TTD) Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30) and Supplemental Lung Cancer Module (QLQ-LC13) in the Global Population
Pain in Arm or Shoulder
|
NA Month
Interval 8.8 to
Insufficient number of participants with events.
|
NA Month
Interval 9.2 to
Insufficient number of participants with events.
|
|
Time to Deterioration (TTD) Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30) and Supplemental Lung Cancer Module (QLQ-LC13) in the Global Population
Dyspnea
|
5.6 Month
Interval 3.6 to 8.8
|
NA Month
Interval 5.5 to
Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline until up to 90 days after end of treatment (up to approximately 49 months)Population: The safety population included all treated participants, defined as participants who received any amount of any component of study treatment. For the safety analyses, patrticipants who received any amount of atezolizumab were analyzed as part of the Atezo + CE arm, even if atezolizumab was given in error.
The percentage of participants with at least one adverse event in the global population.
Outcome measures
| Measure |
Placebo + Carboplatin + Etoposide
n=196 Participants
Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide
n=198 Participants
Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
|---|---|---|
|
Percentage of Participants With at Least One Adverse Event in the Global Population
|
96.4 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Predose (0 hours [H]) on Day (D) 1 of Cycles (C) 1, 2, 3, 4, 8, 16, and every 8 cycles (Q8C) thereafter (cycle = 21 days) until treatment discontinuation (up to 23 months) and 120 days after last dose (up to approximately 23 months overall)Population: ADA analyses were based on ADA observations from participants who had received atezolizumab treatment and were evaluated for immunogenicity.
The baseline prevalence and post-baseline incidence of ADAs against atezolizumab.
Outcome measures
| Measure |
Placebo + Carboplatin + Etoposide
n=198 Participants
Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide
Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
|---|---|---|
|
Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab in the Global Population
Baseline evaluable participants
|
2.0 Percentage of participants
|
—
|
|
Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab in the Global Population
Post-baseline evaluable participants
|
18.6 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Post-dose Day 1 of Cycle 1 (cycle length = 21 days)Population: PK analyses were based on PK observations from all participants who had received atezolizumab, carboplatin, or etoposide treatment and who provided at least one evaluable atezolizumab PK sample.
Atezolizumab maximum observed plasma concentration (Cmax; 30 minutes following the end of the atezolizumab infusion) for each respective day.
Outcome measures
| Measure |
Placebo + Carboplatin + Etoposide
n=185 Participants
Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide
Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Atezolizumab in the Global Population
|
389 μg/mL
Standard Deviation 135
|
—
|
SECONDARY outcome
Timeframe: Predose on Day 1 of Cycles 1, 3, 4, 8, 16 and 24 (cycle length = 21 days)Population: PK analyses were based on PK observations from all participants who had received atezolizumab, carboplatin, or etoposide treatment and who provided at least one evaluable atezolizumab PK sample.
Atezolizumab pre-dose plasma concentration (Cmin) for each respective day.
Outcome measures
| Measure |
Placebo + Carboplatin + Etoposide
n=194 Participants
Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide
Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
|---|---|---|
|
Minimum Observed Serum Concentration (Cmin) of Atezolizumab in the Global Population
Cycle 1 Day 1
|
NA μg/mL
Standard Deviation NA
Below the level of detection.
|
—
|
|
Minimum Observed Serum Concentration (Cmin) of Atezolizumab in the Global Population
Cycle 3 Day1
|
80.6 μg/mL
Standard Deviation 32.1
|
—
|
|
Minimum Observed Serum Concentration (Cmin) of Atezolizumab in the Global Population
Cycle 4 Day 1
|
138 μg/mL
Standard Deviation 56.4
|
—
|
|
Minimum Observed Serum Concentration (Cmin) of Atezolizumab in the Global Population
Cycle 8 Day 1
|
186 μg/mL
Standard Deviation 73.5
|
—
|
|
Minimum Observed Serum Concentration (Cmin) of Atezolizumab in the Global Population
Cycle 16 Day 1
|
196 μg/mL
Standard Deviation 63.1
|
—
|
|
Minimum Observed Serum Concentration (Cmin) of Atezolizumab in the Global Population
Cycle 24 Day 1
|
221 μg/mL
Standard Deviation 43.4
|
—
|
SECONDARY outcome
Timeframe: Predose, before end of infusion, and after end of carboplatin infusion on Day 1 of Cycle 1 and Cycle 3 (cycle = 21 days)Population: PK analyses were based on PK observations from all participants who had received atezolizumab, carboplatin, or etoposide treatment and who provided at least one evaluable atezolizumab PK sample.
Plasma concentration of carboplatin in the Global population.
Outcome measures
| Measure |
Placebo + Carboplatin + Etoposide
n=13 Participants
Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide
n=13 Participants
Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
|---|---|---|
|
Plasma Concentration of Carboplatin in the Global Population
Pre-Dose on Day 1 of Cycle 1
|
NA ng/mL
Standard Deviation NA
Below level of detection.
|
NA ng/mL
Standard Deviation NA
Below level of detection.
|
|
Plasma Concentration of Carboplatin in the Global Population
Before End of Infusion on Day 1 of Cycle 1
|
13300 ng/mL
Standard Deviation 4880
|
11200 ng/mL
Standard Deviation 5060
|
|
Plasma Concentration of Carboplatin in the Global Population
Post Infusion on Day 1 of Cycle 1
|
7200 ng/mL
Standard Deviation 1880
|
6860 ng/mL
Standard Deviation 1670
|
|
Plasma Concentration of Carboplatin in the Global Population
Pre-Dose on Day 1 of Cycle 3
|
144 ng/mL
Standard Deviation 58.3
|
126 ng/mL
Standard Deviation 48.1
|
|
Plasma Concentration of Carboplatin in the Global Population
Before End of Infusion on Day 1 of Cycle 3
|
13900 ng/mL
Standard Deviation 3590
|
11300 ng/mL
Standard Deviation 5090
|
|
Plasma Concentration of Carboplatin in the Global Population
Post Infusion on Day 1 of Cycle 3
|
7180 ng/mL
Standard Deviation 1630
|
6540 ng/mL
Standard Deviation 2200
|
SECONDARY outcome
Timeframe: Predose, before end of infusion, 1 and 4 hours after end of carboplatin infusion on Day 1 of Cycle 1 and Cycle 3 (cycle = 21 days)Population: PK analyses were based on PK observations from all participants who had received atezolizumab, carboplatin, or etoposide treatment and who provided at least one evaluable atezolizumab PK sample.
Plasma concentration of etoposide in the Global Population.
Outcome measures
| Measure |
Placebo + Carboplatin + Etoposide
n=13 Participants
Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide
n=13 Participants
Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
|---|---|---|
|
Plasma Concentration of Etoposide in the Global Population
Pre-Dose on Day 1 of Cycle 1
|
NA ng/mL
Standard Deviation NA
Below level of detection.
|
NA ng/mL
Standard Deviation NA
Below level of detection.
|
|
Plasma Concentration of Etoposide in the Global Population
Before End of Infusion on Day 1 of Cycle 1
|
17000 ng/mL
Standard Deviation 3640
|
19400 ng/mL
Standard Deviation 2860
|
|
Plasma Concentration of Etoposide in the Global Population
1 Hour Post Infusion on Day 1 of Cycle 1
|
11100 ng/mL
Standard Deviation 2010
|
12600 ng/mL
Standard Deviation 1960
|
|
Plasma Concentration of Etoposide in the Global Population
4 Hours Post Infusion on Day 1 of Cycle 1
|
7640 ng/mL
Standard Deviation 2360
|
7300 ng/mL
Standard Deviation 1230
|
|
Plasma Concentration of Etoposide in the Global Population
Pre-Dose on Day 1 of Cycle 3
|
NA ng/mL
Standard Deviation NA
Below level of detection.
|
NA ng/mL
Standard Deviation NA
Below level of detection.
|
|
Plasma Concentration of Etoposide in the Global Population
Before End of Infusion on Day 1 of Cycle 3
|
16600 ng/mL
Standard Deviation 2180
|
17700 ng/mL
Standard Deviation 3600
|
|
Plasma Concentration of Etoposide in the Global Population
1 Hour Post Infusion on Day 1 of Cycle 3
|
12400 ng/mL
Standard Deviation 3740
|
12200 ng/mL
Standard Deviation 2810
|
|
Plasma Concentration of Etoposide in the Global Population
4 Hours Post Infusion on Day 1 of Cycle 3
|
6740 ng/mL
Standard Deviation 1230
|
7960 ng/mL
Standard Deviation 2090
|
Adverse Events
Placebo + Carboplatin + Etoposide - Global
Serious events: 69 serious events
Other events: 187 other events
Deaths: 11 deaths
Atezolizumab + Carboplatin + Etoposide - Global
Serious events: 81 serious events
Other events: 191 other events
Deaths: 5 deaths
Placebo + Carboplatin + Etoposide - China
Serious events: 14 serious events
Other events: 52 other events
Deaths: 1 deaths
Atezolizumab + Carboplatin + Etoposide - China
Serious events: 22 serious events
Other events: 56 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Placebo + Carboplatin + Etoposide - Global
n=196 participants at risk
Participants in the Global population received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide - Global
n=198 participants at risk
Participants in the Global population received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Placebo + Carboplatin + Etoposide - China
n=52 participants at risk
Participants in the China population received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide - China
n=57 participants at risk
Participants in the China population received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
2/196 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.5%
3/198 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.9%
1/52 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.6%
9/196 • Number of events 9 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
2.5%
5/198 • Number of events 5 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.8%
2/52 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.9%
1/52 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.0%
2/198 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.9%
1/52 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.1%
8/196 • Number of events 8 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.5%
7/198 • Number of events 7 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.9%
1/52 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.0%
4/196 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
4/196 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
2.5%
5/198 • Number of events 5 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.8%
2/52 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
3/196 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.9%
1/52 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.0%
2/198 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.0%
2/198 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.5%
3/198 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.51%
1/196 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
3/196 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.5%
3/198 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
General disorders
Asthenia
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.0%
2/198 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
General disorders
Chest discomfort
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
General disorders
Chest pain
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
General disorders
Death
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.5%
2/57 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.5%
3/198 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
General disorders
General physical health deterioration
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.0%
2/198 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
General disorders
Pain
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.0%
2/198 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.9%
1/52 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.0%
2/198 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.0%
2/198 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Lung abscess
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Myelitis
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Neutropenic sepsis
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Pneumonia
|
5.1%
10/196 • Number of events 11 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
6.1%
12/198 • Number of events 15 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.7%
4/52 • Number of events 5 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.0%
4/57 • Number of events 7 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Pulmonary sepsis
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Pyopneumothorax
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Sepsis
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Septic shock
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
2/196 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.0%
2/198 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.0%
2/196 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Liver function test increased
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Neutrophil count decreased
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.8%
2/52 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.5%
2/57 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Platelet count decreased
|
1.0%
2/196 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.9%
1/52 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.0%
4/57 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Transaminases increased
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
White blood cell count decreased
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.9%
1/52 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.0%
2/198 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.0%
4/196 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.9%
1/52 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Nervous system disorders
Spinal cord oedema
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.5%
3/198 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Psychiatric disorders
Alcohol abuse
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.0%
2/198 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.0%
2/196 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.0%
2/196 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.0%
2/198 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.0%
2/196 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.9%
1/52 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.0%
2/198 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.9%
1/52 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.0%
2/198 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.0%
2/196 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.0%
2/198 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.5%
2/57 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.0%
2/196 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
Other adverse events
| Measure |
Placebo + Carboplatin + Etoposide - Global
n=196 participants at risk
Participants in the Global population received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide - Global
n=198 participants at risk
Participants in the Global population received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Placebo + Carboplatin + Etoposide - China
n=52 participants at risk
Participants in the China population received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
Atezolizumab + Carboplatin + Etoposide - China
n=57 participants at risk
Participants in the China population received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
|
|---|---|---|---|---|
|
Endocrine disorders
Hyperthyroidism
|
2.6%
5/196 • Number of events 5 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.6%
11/198 • Number of events 11 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.5%
2/57 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
10.1%
20/198 • Number of events 20 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.8%
2/52 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
14.0%
8/57 • Number of events 9 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.0%
2/196 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
2.5%
5/198 • Number of events 5 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.9%
1/52 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.3%
3/57 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
11/196 • Number of events 11 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.1%
10/198 • Number of events 10 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
29.6%
58/196 • Number of events 70 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
26.3%
52/198 • Number of events 65 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
15.4%
8/52 • Number of events 12 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
17.5%
10/57 • Number of events 19 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.3%
30/196 • Number of events 46 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
17.2%
34/198 • Number of events 46 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.8%
2/52 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.0%
4/57 • Number of events 5 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
33.2%
65/196 • Number of events 95 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
38.9%
77/198 • Number of events 112 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
19.2%
10/52 • Number of events 15 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
36.8%
21/57 • Number of events 47 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
4.6%
9/196 • Number of events 9 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.6%
11/198 • Number of events 11 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.9%
1/52 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
17.3%
34/196 • Number of events 49 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
20.2%
40/198 • Number of events 52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
13.5%
7/52 • Number of events 7 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
24.6%
14/57 • Number of events 20 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
General disorders
Asthenia
|
10.2%
20/196 • Number of events 26 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
12.6%
25/198 • Number of events 29 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.7%
4/52 • Number of events 5 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.0%
4/57 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
General disorders
Chest discomfort
|
2.6%
5/196 • Number of events 5 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.0%
2/198 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.8%
2/52 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
8.8%
5/57 • Number of events 5 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
General disorders
Chest pain
|
7.1%
14/196 • Number of events 14 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
9.1%
18/198 • Number of events 22 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.7%
4/52 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
8.8%
5/57 • Number of events 5 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
General disorders
Fatigue
|
26.0%
51/196 • Number of events 67 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
26.3%
52/198 • Number of events 66 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
10.5%
6/57 • Number of events 8 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
General disorders
Oedema peripheral
|
3.6%
7/196 • Number of events 8 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
6.6%
13/198 • Number of events 14 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
General disorders
Pyrexia
|
8.2%
16/196 • Number of events 18 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
10.1%
20/198 • Number of events 32 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.7%
4/52 • Number of events 7 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
22.8%
13/57 • Number of events 19 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.8%
3/52 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.3%
3/57 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
1.0%
2/196 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
2.0%
4/198 • Number of events 5 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.7%
4/52 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.3%
3/57 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.7%
17/196 • Number of events 20 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.6%
15/198 • Number of events 19 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.8%
2/52 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.3%
3/57 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
3.1%
6/196 • Number of events 6 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
6.6%
13/198 • Number of events 18 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
9.6%
5/52 • Number of events 5 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.5%
2/57 • Number of events 5 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.1%
8/196 • Number of events 9 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.1%
10/198 • Number of events 13 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.9%
1/52 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
3.1%
6/196 • Number of events 6 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.0%
6/198 • Number of events 13 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
19.2%
10/52 • Number of events 15 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
22.8%
13/57 • Number of events 21 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
2.6%
5/196 • Number of events 7 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
4.0%
8/198 • Number of events 9 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
17.3%
9/52 • Number of events 16 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
19.3%
11/57 • Number of events 15 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.5%
3/196 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
4.0%
8/198 • Number of events 8 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.8%
3/52 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
9.6%
5/52 • Number of events 6 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.5%
2/57 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.7%
4/52 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
14.0%
8/57 • Number of events 23 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Blood creatinine increased
|
1.5%
3/196 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.5%
7/198 • Number of events 13 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.8%
3/52 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.0%
4/57 • Number of events 8 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Blood glucose increased
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.8%
3/52 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.3%
3/57 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
35.2%
69/196 • Number of events 84 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
43.4%
86/198 • Number of events 101 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
76.9%
40/52 • Number of events 50 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
80.7%
46/57 • Number of events 76 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.7%
19/196 • Number of events 32 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
12.1%
24/198 • Number of events 44 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
26.9%
14/52 • Number of events 22 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
15.8%
9/57 • Number of events 24 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.7%
66/196 • Number of events 105 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
35.9%
71/198 • Number of events 122 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
32.7%
17/52 • Number of events 41 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
19.3%
11/57 • Number of events 32 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.8%
29/196 • Number of events 44 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
15.7%
31/198 • Number of events 46 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
30.8%
16/52 • Number of events 31 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
29.8%
17/57 • Number of events 27 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.51%
1/196 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.0%
2/198 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.7%
4/52 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Weight increased
|
3.1%
6/196 • Number of events 7 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.5%
3/198 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.7%
4/52 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
White blood cell count decreased
|
12.2%
24/196 • Number of events 43 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
9.1%
18/198 • Number of events 35 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
55.8%
29/52 • Number of events 73 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
59.6%
34/57 • Number of events 101 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.7%
4/52 • Number of events 5 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
10.5%
6/57 • Number of events 18 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.8%
3/52 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.7%
4/52 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.5%
2/57 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Haemoglobin decreased
|
1.5%
3/196 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.0%
4/57 • Number of events 6 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Neutrophil count decreased
|
23.0%
45/196 • Number of events 80 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
18.7%
37/198 • Number of events 74 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
63.5%
33/52 • Number of events 85 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
71.9%
41/57 • Number of events 107 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Platelet count decreased
|
15.3%
30/196 • Number of events 41 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
13.1%
26/198 • Number of events 38 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
26.9%
14/52 • Number of events 26 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
42.1%
24/57 • Number of events 40 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Protein urine present
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.8%
3/52 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Weight decreased
|
5.1%
10/196 • Number of events 11 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
10.6%
21/198 • Number of events 21 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
11.5%
6/52 • Number of events 6 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
17.5%
10/57 • Number of events 10 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.9%
41/196 • Number of events 45 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
27.8%
55/198 • Number of events 64 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
23.1%
12/52 • Number of events 16 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
22.8%
13/57 • Number of events 22 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.51%
1/198 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.8%
3/52 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.6%
5/196 • Number of events 7 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
4.5%
9/198 • Number of events 13 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.8%
2/52 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.0%
4/57 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.3%
3/57 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.0%
2/196 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.5%
3/198 • Number of events 5 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
9.6%
5/52 • Number of events 5 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
15.8%
9/57 • Number of events 14 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
1.0%
2/196 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.7%
4/52 • Number of events 7 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
8.8%
5/57 • Number of events 6 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.7%
17/196 • Number of events 18 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
4.5%
9/198 • Number of events 9 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
9.6%
5/52 • Number of events 10 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
8.8%
5/57 • Number of events 8 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.1%
10/196 • Number of events 10 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
6.6%
13/198 • Number of events 19 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.8%
2/52 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.1%
12/196 • Number of events 14 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.1%
10/198 • Number of events 10 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
21.2%
11/52 • Number of events 17 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
17.5%
10/57 • Number of events 12 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/196 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.8%
3/52 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.0%
4/57 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.2%
22/196 • Number of events 29 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
12.6%
25/198 • Number of events 31 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.7%
4/52 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.8%
1/57 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.2%
18/196 • Number of events 20 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
9.6%
19/198 • Number of events 19 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.3%
3/57 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.1%
8/196 • Number of events 9 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
6.6%
13/198 • Number of events 13 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.8%
2/52 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.5%
2/57 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Nervous system disorders
Dizziness
|
5.6%
11/196 • Number of events 14 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
10.1%
20/198 • Number of events 23 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.8%
2/52 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.5%
2/57 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Nervous system disorders
Headache
|
11.7%
23/196 • Number of events 26 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
12.6%
25/198 • Number of events 30 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.8%
3/52 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.3%
3/57 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Psychiatric disorders
Insomnia
|
7.1%
14/196 • Number of events 14 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
8.1%
16/198 • Number of events 19 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.8%
3/52 • Number of events 9 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.0%
4/57 • Number of events 8 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.51%
1/196 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/198 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
13.5%
7/52 • Number of events 10 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.5%
2/57 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
28/196 • Number of events 33 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
11.1%
22/198 • Number of events 28 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
19.2%
10/52 • Number of events 12 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
24.6%
14/57 • Number of events 20 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.7%
17/196 • Number of events 18 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
10.6%
21/198 • Number of events 24 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.8%
2/52 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.5%
2/57 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.1%
12/196 • Number of events 12 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.1%
14/198 • Number of events 20 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
9.6%
5/52 • Number of events 6 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.0%
4/57 • Number of events 4 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.6%
5/196 • Number of events 6 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
6.6%
13/198 • Number of events 17 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.5%
2/57 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.6%
9/196 • Number of events 14 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.1%
10/198 • Number of events 10 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
9.6%
5/52 • Number of events 5 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
12.3%
7/57 • Number of events 7 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
35.2%
69/196 • Number of events 72 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
36.9%
73/198 • Number of events 75 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
34.6%
18/52 • Number of events 18 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
43.9%
25/57 • Number of events 26 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.6%
9/196 • Number of events 10 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.6%
15/198 • Number of events 17 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.9%
1/52 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.5%
2/57 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.6%
13/196 • Number of events 15 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.6%
15/198 • Number of events 25 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
1.9%
1/52 • Number of events 1 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
10.5%
6/57 • Number of events 9 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.0%
2/196 • Number of events 3 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
5.6%
11/198 • Number of events 11 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/52 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Vascular disorders
Hypertension
|
3.1%
6/196 • Number of events 8 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
7.6%
15/198 • Number of events 20 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
3.8%
2/52 • Number of events 2 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
0.00%
0/57 • From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER