Trial Outcomes & Findings for A Safety Trial of Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Chemotherapy Regimen (NCT NCT02066636)
NCT ID: NCT02066636
Last Updated: 2022-10-27
Results Overview
A treatment related adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that has a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1428 participants
Primary outcome timeframe
From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)
Results posted on
2022-10-27
Participant Flow
After 1 year of treatment, participants who are still on treatment are randomized to Cohort A or Cohort B.
Participant milestones
| Measure |
Cohort A: Nivolumab Monotherapy
Participants receive nivolumab administered intravenously at 3 mg/kg every two weeks. Each 14 day dosing period will constitute a cycle. After 1 year (52 weeks) of treatment all participants will continue to receive treatment until disease progression, unacceptable toxicity, or withdrawal of informed consent.
|
Cohort B: Nivolumab Monotherapy
Participants receive nivolumab administered intravenously at 3 mg/kg every two weeks. Each 14 day dosing period will constitute a cycle. After 1 year (52 weeks) of treatment all participants will discontinue treatment. Upon progression, participants can receive retreatment.
|
Nivolumab Monotherapy (Not Randomized)
Participants receive nivolumab administered intravenously at 3 mg/kg every two weeks. Non-randomized participants were those participants who were enrolled but (after 1 year) were not randomized to either of the study cohorts (Cohort A or B).
|
|---|---|---|---|
|
Overall Study
STARTED
|
127
|
125
|
1176
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
127
|
125
|
1176
|
Reasons for withdrawal
| Measure |
Cohort A: Nivolumab Monotherapy
Participants receive nivolumab administered intravenously at 3 mg/kg every two weeks. Each 14 day dosing period will constitute a cycle. After 1 year (52 weeks) of treatment all participants will continue to receive treatment until disease progression, unacceptable toxicity, or withdrawal of informed consent.
|
Cohort B: Nivolumab Monotherapy
Participants receive nivolumab administered intravenously at 3 mg/kg every two weeks. Each 14 day dosing period will constitute a cycle. After 1 year (52 weeks) of treatment all participants will discontinue treatment. Upon progression, participants can receive retreatment.
|
Nivolumab Monotherapy (Not Randomized)
Participants receive nivolumab administered intravenously at 3 mg/kg every two weeks. Non-randomized participants were those participants who were enrolled but (after 1 year) were not randomized to either of the study cohorts (Cohort A or B).
|
|---|---|---|---|
|
Overall Study
Disease progression
|
51
|
60
|
700
|
|
Overall Study
Study drug toxicity
|
13
|
2
|
58
|
|
Overall Study
Death
|
4
|
2
|
158
|
|
Overall Study
Adverse event unrelated to study drug
|
6
|
4
|
45
|
|
Overall Study
Participant request to discontinue treatment
|
12
|
12
|
70
|
|
Overall Study
Participant withdrew consent
|
10
|
18
|
61
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
2
|
|
Overall Study
Maximum clinical benefit
|
2
|
2
|
3
|
|
Overall Study
Poor/non-compliance
|
2
|
1
|
1
|
|
Overall Study
Participant no loner meets study criteria
|
3
|
2
|
28
|
|
Overall Study
Administrative reasons by sponsor
|
8
|
5
|
0
|
|
Overall Study
Other reasons
|
16
|
15
|
50
|
Baseline Characteristics
A Safety Trial of Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Chemotherapy Regimen
Baseline characteristics by cohort
| Measure |
Cohort A: Nivolumab Monotherapy
n=127 Participants
Participants receive nivolumab administered intravenously at 3 mg/kg every two weeks. Each 14 day dosing period will constitute a cycle. After 1 year (52 weeks) of treatment all participants will continue to receive treatment until disease progression, unacceptable toxicity, or withdrawal of informed consent.
|
Cohort B: Nivolumab Monotherapy
n=125 Participants
Participants receive nivolumab administered intravenously at 3 mg/kg every two weeks. Each 14 day dosing period will constitute a cycle. After 1 year (52 weeks) of treatment all participants will discontinue treatment. Upon progression, participants can receive retreatment.
|
Nivolumab Monotherapy (Not Randomized)
n=1176 Participants
Participants receive nivolumab administered intravenously at 3 mg/kg every two weeks. Non-randomized participants were those participants who were enrolled but (after 1 year) were not randomized to either of the study cohorts (Cohort A or B).
|
Total
n=1428 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.2 Years
STANDARD_DEVIATION 10.27 • n=99 Participants
|
66.6 Years
STANDARD_DEVIATION 7.97 • n=107 Participants
|
66.1 Years
STANDARD_DEVIATION 9.82 • n=206 Participants
|
66.1 Years
STANDARD_DEVIATION 9.71 • n=7 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
528 Participants
n=206 Participants
|
657 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
648 Participants
n=206 Participants
|
771 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
124 Participants
n=99 Participants
|
118 Participants
n=107 Participants
|
1139 Participants
n=206 Participants
|
1381 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
105 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
111 Participants
n=99 Participants
|
114 Participants
n=107 Participants
|
1041 Participants
n=206 Participants
|
1266 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)Population: All treated participants prior to randomization and treated participants randomized to Cohort A and B
A treatment related adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that has a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.
Outcome measures
| Measure |
Cohort A: Nivolumab Monotherapy (Post-Randomization)
n=127 Participants
All participants that continued to receive treatment after completing 1 year (52 weeks) of nivolumab administered intravenously at 3 mg/kg every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent.
|
Cohort B: Nivolumab Monotherapy (Post-Randomization)
n=125 Participants
All participants that discontinued treatment after 1 year (52 weeks) of receiving nivolumab administered intravenously at 3 mg/kg every two weeks. Upon progression, participants can receive retreatment.
|
Nivolumab Monotherapy (Pre-Randomized)
n=1428 Participants
All Participants that received nivolumab administered intravenously at 3 mg/kg every two weeks for up to 1 year.
|
|---|---|---|---|
|
The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5)
Gastrointestinal Adverse Event (Grade 5)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5)
Hepatic Adverse Event (Grade3-4)
|
1 Participants
|
0 Participants
|
19 Participants
|
|
The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5)
Skin Adverse Event (Grade3-4)
|
1 Participants
|
1 Participants
|
15 Participants
|
|
The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5)
Hypersensitivity/Infusion Reaction Events (Grade3-4)
|
0 Participants
|
0 Participants
|
4 Participants
|
|
The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5)
Hypersensitivity/Infusion Reaction Events (Grade 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5)
Endocrinopathies (Grade 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5)
Gastrointestinal Adverse Event (Grade3-4)
|
3 Participants
|
0 Participants
|
20 Participants
|
|
The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5)
Hepatic Adverse Event (Grade 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5)
Pulmonary Adverse Event (Grade3-4)
|
1 Participants
|
1 Participants
|
18 Participants
|
|
The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5)
Pulmonary Adverse Event (Grade 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5)
Renal Adverse Event (Grade3-4)
|
0 Participants
|
0 Participants
|
4 Participants
|
|
The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5)
Renal Adverse Event (Grade 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5)
Skin Adverse Event (Grade 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5)
Endocrinopathies (Grade3-4)
|
0 Participants
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)Population: All treated participants (both included and excluded from Cohort randomization) with at least one select adverse event from the category
The time from first dose to the first occurrence of any select adverse event of interest. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.
Outcome measures
| Measure |
Cohort A: Nivolumab Monotherapy (Post-Randomization)
n=10 Participants
All participants that continued to receive treatment after completing 1 year (52 weeks) of nivolumab administered intravenously at 3 mg/kg every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent.
|
Cohort B: Nivolumab Monotherapy (Post-Randomization)
n=4 Participants
All participants that discontinued treatment after 1 year (52 weeks) of receiving nivolumab administered intravenously at 3 mg/kg every two weeks. Upon progression, participants can receive retreatment.
|
Nivolumab Monotherapy (Pre-Randomized)
n=38 Participants
All Participants that received nivolumab administered intravenously at 3 mg/kg every two weeks for up to 1 year.
|
|---|---|---|---|
|
Median Time to Onset of Select Adverse Events (Grade 3-5)
Endocrine Adverse Event
|
12.14 Weeks
Interval 11.0 to 45.4
|
25.3 Weeks
Interval 25.3 to 25.3
|
11.14 Weeks
Interval 5.6 to 42.7
|
|
Median Time to Onset of Select Adverse Events (Grade 3-5)
Gastrointestinal Adverse Event
|
82.71 Weeks
Interval 22.7 to 272.3
|
49.21 Weeks
Interval 33.9 to 59.4
|
17.86 Weeks
Interval 0.7 to 46.1
|
|
Median Time to Onset of Select Adverse Events (Grade 3-5)
Hepatic Adverse Event
|
84.50 Weeks
Interval 16.4 to 152.6
|
—
|
4.14 Weeks
Interval 1.3 to 42.1
|
|
Median Time to Onset of Select Adverse Events (Grade 3-5)
Pulmonary Adverse Event
|
156.21 Weeks
Interval 97.9 to 214.6
|
—
|
7.79 Weeks
Interval 0.6 to 35.9
|
|
Median Time to Onset of Select Adverse Events (Grade 3-5)
Renal Adverse Event
|
108.00 Weeks
Interval 35.9 to 180.1
|
15.1 Weeks
Interval 15.1 to 15.1
|
6.71 Weeks
Interval 3.0 to 49.6
|
|
Median Time to Onset of Select Adverse Events (Grade 3-5)
Skin Adverse Event
|
26.14 Weeks
Interval 0.1 to 48.1
|
18.14 Weeks
Interval 16.1 to 20.1
|
10.57 Weeks
Interval 2.1 to 51.6
|
|
Median Time to Onset of Select Adverse Events (Grade 3-5)
Hypersensitivity/Infusion Reaction
|
—
|
42.00 Weeks
Interval 42.0 to 42.0
|
2.36 Weeks
Interval 2.0 to 8.1
|
SECONDARY outcome
Timeframe: From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)Population: All treated participants (both included and excluded from Cohort randomization) with at least one select adverse event from the category
The time from the onset of any select adverse event of interest to its resolution or stabilization. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.
Outcome measures
| Measure |
Cohort A: Nivolumab Monotherapy (Post-Randomization)
n=10 Participants
All participants that continued to receive treatment after completing 1 year (52 weeks) of nivolumab administered intravenously at 3 mg/kg every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent.
|
Cohort B: Nivolumab Monotherapy (Post-Randomization)
n=4 Participants
All participants that discontinued treatment after 1 year (52 weeks) of receiving nivolumab administered intravenously at 3 mg/kg every two weeks. Upon progression, participants can receive retreatment.
|
Nivolumab Monotherapy (Pre-Randomized)
n=38 Participants
All Participants that received nivolumab administered intravenously at 3 mg/kg every two weeks for up to 1 year.
|
|---|---|---|---|
|
Median Time to Resolution of Select Adverse Events (Grade 3-5)
Endocrine Adverse Event
|
3.43 Weeks
Interval 0.4 to 36.1
|
1.00 Weeks
Interval 1.0 to 1.0
|
3.57 Weeks
Interval 0.9 to 4.4
|
|
Median Time to Resolution of Select Adverse Events (Grade 3-5)
Gastrointestinal Adverse Event
|
4.79 Weeks
Interval 0.4 to 29.4
|
1.50 Weeks
Interval 0.3 to 3.0
|
1.86 Weeks
Interval 0.6 to 27.1
|
|
Median Time to Resolution of Select Adverse Events (Grade 3-5)
Hepatic Adverse Event
|
1.36 Weeks
Interval 0.4 to 2.3
|
—
|
12.57 Weeks
Interval 0.1 to 36.9
|
|
Median Time to Resolution of Select Adverse Events (Grade 3-5)
Pulmonary Adverse Event
|
1.14 Weeks
Interval 0.7 to 1.6
|
—
|
2.57 Weeks
Interval 0.1 to 30.3
|
|
Median Time to Resolution of Select Adverse Events (Grade 3-5)
Hypersensitivity/Infusion Reaction
|
—
|
0.1 Weeks
Interval 0.1 to 0.1
|
0.1 Weeks
Interval 0.1 to 0.1
|
|
Median Time to Resolution of Select Adverse Events (Grade 3-5)
Renal Adverse Event
|
0.64 Weeks
Interval 0.4 to 0.9
|
1.9 Weeks
Interval 1.9 to 1.9
|
1.29 Weeks
Interval 0.3 to 5.1
|
|
Median Time to Resolution of Select Adverse Events (Grade 3-5)
Skin Adverse Event
|
2.57 Weeks
Interval 2.1 to 32.9
|
2.43 Weeks
Interval 2.1 to 2.7
|
9.14 Weeks
Interval 1.0 to 234.0
|
SECONDARY outcome
Timeframe: From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)Population: All treated participants (both included and excluded from Cohort randomization) with at least one select adverse event from the category
The number of participants receiving medication meant to trigger an immune response for any select Adverse events of interest. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.
Outcome measures
| Measure |
Cohort A: Nivolumab Monotherapy (Post-Randomization)
n=40 Participants
All participants that continued to receive treatment after completing 1 year (52 weeks) of nivolumab administered intravenously at 3 mg/kg every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent.
|
Cohort B: Nivolumab Monotherapy (Post-Randomization)
n=17 Participants
All participants that discontinued treatment after 1 year (52 weeks) of receiving nivolumab administered intravenously at 3 mg/kg every two weeks. Upon progression, participants can receive retreatment.
|
Nivolumab Monotherapy (Pre-Randomized)
n=314 Participants
All Participants that received nivolumab administered intravenously at 3 mg/kg every two weeks for up to 1 year.
|
|---|---|---|---|
|
The Number of Participants Who Received Immune Modulating Medication (or Hormonal Replacement Therapy) for Any Grade Select Adverse Events
Endocrine Adverse Event
|
1 Participants
|
2 Participants
|
15 Participants
|
|
The Number of Participants Who Received Immune Modulating Medication (or Hormonal Replacement Therapy) for Any Grade Select Adverse Events
Hypersensitivity/Infusion Reaction
|
2 Participants
|
1 Participants
|
14 Participants
|
|
The Number of Participants Who Received Immune Modulating Medication (or Hormonal Replacement Therapy) for Any Grade Select Adverse Events
Gastrointestinal Adverse Event
|
5 Participants
|
2 Participants
|
35 Participants
|
|
The Number of Participants Who Received Immune Modulating Medication (or Hormonal Replacement Therapy) for Any Grade Select Adverse Events
Hepatic Adverse Event
|
0 Participants
|
0 Participants
|
13 Participants
|
|
The Number of Participants Who Received Immune Modulating Medication (or Hormonal Replacement Therapy) for Any Grade Select Adverse Events
Pulmonary Adverse Event
|
11 Participants
|
4 Participants
|
42 Participants
|
|
The Number of Participants Who Received Immune Modulating Medication (or Hormonal Replacement Therapy) for Any Grade Select Adverse Events
Renal Adverse Event
|
1 Participants
|
0 Participants
|
12 Participants
|
|
The Number of Participants Who Received Immune Modulating Medication (or Hormonal Replacement Therapy) for Any Grade Select Adverse Events
Skin Adverse Event
|
17 Participants
|
8 Participants
|
113 Participants
|
SECONDARY outcome
Timeframe: From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)Population: All treated participants (both included and excluded from Cohort randomization) with at least one select adverse event from the category
The number of participants receiving \> 40mg prednisone equivalents for any select adverse event of interest. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.
Outcome measures
| Measure |
Cohort A: Nivolumab Monotherapy (Post-Randomization)
n=40 Participants
All participants that continued to receive treatment after completing 1 year (52 weeks) of nivolumab administered intravenously at 3 mg/kg every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent.
|
Cohort B: Nivolumab Monotherapy (Post-Randomization)
n=17 Participants
All participants that discontinued treatment after 1 year (52 weeks) of receiving nivolumab administered intravenously at 3 mg/kg every two weeks. Upon progression, participants can receive retreatment.
|
Nivolumab Monotherapy (Pre-Randomized)
n=314 Participants
All Participants that received nivolumab administered intravenously at 3 mg/kg every two weeks for up to 1 year.
|
|---|---|---|---|
|
The Number of Participants Who Received ≥ 40 mg Prednisone Equivalents for Any Grade Select Adverse Events
Gastrointestinal Adverse Event
|
3 Participants
|
2 Participants
|
21 Participants
|
|
The Number of Participants Who Received ≥ 40 mg Prednisone Equivalents for Any Grade Select Adverse Events
Hepatic Adverse Event
|
0 Participants
|
0 Participants
|
8 Participants
|
|
The Number of Participants Who Received ≥ 40 mg Prednisone Equivalents for Any Grade Select Adverse Events
Renal Adverse Event
|
1 Participants
|
0 Participants
|
10 Participants
|
|
The Number of Participants Who Received ≥ 40 mg Prednisone Equivalents for Any Grade Select Adverse Events
Skin Adverse Event
|
2 Participants
|
2 Participants
|
14 Participants
|
|
The Number of Participants Who Received ≥ 40 mg Prednisone Equivalents for Any Grade Select Adverse Events
Endocrine Adverse Event
|
0 Participants
|
0 Participants
|
5 Participants
|
|
The Number of Participants Who Received ≥ 40 mg Prednisone Equivalents for Any Grade Select Adverse Events
Pulmonary Adverse Event
|
7 Participants
|
4 Participants
|
31 Participants
|
|
The Number of Participants Who Received ≥ 40 mg Prednisone Equivalents for Any Grade Select Adverse Events
Hypersensitivity/Infusion Reaction
|
2 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From first dose first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)Population: All treated participants (both included and excluded from Cohort randomization) with at least one select adverse event from the category
The duration of time participants received medication meant to trigger an immune response for any select Adverse events of interest. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.
Outcome measures
| Measure |
Cohort A: Nivolumab Monotherapy (Post-Randomization)
n=40 Participants
All participants that continued to receive treatment after completing 1 year (52 weeks) of nivolumab administered intravenously at 3 mg/kg every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent.
|
Cohort B: Nivolumab Monotherapy (Post-Randomization)
n=17 Participants
All participants that discontinued treatment after 1 year (52 weeks) of receiving nivolumab administered intravenously at 3 mg/kg every two weeks. Upon progression, participants can receive retreatment.
|
Nivolumab Monotherapy (Pre-Randomized)
n=314 Participants
All Participants that received nivolumab administered intravenously at 3 mg/kg every two weeks for up to 1 year.
|
|---|---|---|---|
|
The Total Duration of All Immune Modulating Medications for Any Grade Select Adverse Events
Gastrointestinal Adverse Event
|
5.43 Weeks
Interval 2.4 to 8.1
|
2.50 Weeks
Interval 1.6 to 3.4
|
3.79 Weeks
Interval 0.4 to 32.6
|
|
The Total Duration of All Immune Modulating Medications for Any Grade Select Adverse Events
Hepatic Adverse Event
|
NA Weeks
Insufficient number of participants with events
|
NA Weeks
Insufficient number of participants with events
|
5.0 Weeks
Interval 0.4 to 14.0
|
|
The Total Duration of All Immune Modulating Medications for Any Grade Select Adverse Events
Pulmonary Adverse Event
|
6.57 Weeks
Interval 0.3 to 27.1
|
2.86 Weeks
Interval 1.1 to 5.9
|
3.57 Weeks
Interval 0.1 to 26.1
|
|
The Total Duration of All Immune Modulating Medications for Any Grade Select Adverse Events
Renal Adverse Event
|
0.7 Weeks
Interval 0.7 to 0.7
|
NA Weeks
Insufficient number of participants with events
|
2.57 Weeks
Interval 0.3 to 16.9
|
|
The Total Duration of All Immune Modulating Medications for Any Grade Select Adverse Events
Endocrine Adverse Event
|
NA Weeks
Insufficient number of participants with events
|
82.57 Weeks
Interval 2.0 to 163.1
|
2.57 Weeks
Interval 0.1 to 76.0
|
|
The Total Duration of All Immune Modulating Medications for Any Grade Select Adverse Events
Skin Adverse Event
|
18.14 Weeks
Interval 0.9 to 151.0
|
6.71 Weeks
Interval 1.0 to 16.4
|
4.07 Weeks
Interval 0.1 to 80.1
|
|
The Total Duration of All Immune Modulating Medications for Any Grade Select Adverse Events
Hypersensitivity/Infusion Reaction
|
2.71 Weeks
Interval 1.0 to 4.4
|
2.0 Weeks
Interval 2.0 to 2.0
|
0.14 Weeks
Interval 0.1 to 2.1
|
SECONDARY outcome
Timeframe: From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)Population: All treated participants prior to randomization and treated participants randomized to Cohort A and B
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.
Outcome measures
| Measure |
Cohort A: Nivolumab Monotherapy (Post-Randomization)
n=127 Participants
All participants that continued to receive treatment after completing 1 year (52 weeks) of nivolumab administered intravenously at 3 mg/kg every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent.
|
Cohort B: Nivolumab Monotherapy (Post-Randomization)
n=125 Participants
All participants that discontinued treatment after 1 year (52 weeks) of receiving nivolumab administered intravenously at 3 mg/kg every two weeks. Upon progression, participants can receive retreatment.
|
Nivolumab Monotherapy (Pre-Randomized)
n=1428 Participants
All Participants that received nivolumab administered intravenously at 3 mg/kg every two weeks for up to 1 year.
|
|---|---|---|---|
|
The Number of Participants With High Grade (Grade 3-4 and Grade 5) Select Adverse Events
Gastrointestinal Adverse Event (Grade3-4)
|
7 Participants
|
2 Participants
|
35 Participants
|
|
The Number of Participants With High Grade (Grade 3-4 and Grade 5) Select Adverse Events
Gastrointestinal Adverse Event (Grade 5)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
The Number of Participants With High Grade (Grade 3-4 and Grade 5) Select Adverse Events
Hepatic Adverse Event (Grade3-4)
|
1 Participants
|
0 Participants
|
34 Participants
|
|
The Number of Participants With High Grade (Grade 3-4 and Grade 5) Select Adverse Events
Hepatic Adverse Event (Grade 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With High Grade (Grade 3-4 and Grade 5) Select Adverse Events
Pulmonary Adverse Event (Grade 5)
|
0 Participants
|
0 Participants
|
7 Participants
|
|
The Number of Participants With High Grade (Grade 3-4 and Grade 5) Select Adverse Events
Skin Adverse Event (Grade3-4)
|
1 Participants
|
2 Participants
|
18 Participants
|
|
The Number of Participants With High Grade (Grade 3-4 and Grade 5) Select Adverse Events
Hypersensitivity/Infusion Reaction Events (Grade3-4)
|
0 Participants
|
0 Participants
|
5 Participants
|
|
The Number of Participants With High Grade (Grade 3-4 and Grade 5) Select Adverse Events
Hypersensitivity/Infusion Reaction Events (Grade 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With High Grade (Grade 3-4 and Grade 5) Select Adverse Events
Endocrinopathies (Grade3-4)
|
0 Participants
|
0 Participants
|
8 Participants
|
|
The Number of Participants With High Grade (Grade 3-4 and Grade 5) Select Adverse Events
Pulmonary Adverse Event (Grade3-4)
|
2 Participants
|
3 Participants
|
31 Participants
|
|
The Number of Participants With High Grade (Grade 3-4 and Grade 5) Select Adverse Events
Renal Adverse Event (Grade3-4)
|
1 Participants
|
1 Participants
|
14 Participants
|
|
The Number of Participants With High Grade (Grade 3-4 and Grade 5) Select Adverse Events
Renal Adverse Event (Grade 5)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
The Number of Participants With High Grade (Grade 3-4 and Grade 5) Select Adverse Events
Skin Adverse Event (Grade 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With High Grade (Grade 3-4 and Grade 5) Select Adverse Events
Endocrinopathies (Grade 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort A: Nivolumab Monotherapy (Post-Randomization)
Serious events: 57 serious events
Other events: 101 other events
Deaths: 63 deaths
Cohort B: Nivolumab Monotherapy (Post-Randomization)
Serious events: 52 serious events
Other events: 82 other events
Deaths: 77 deaths
Nivolumab Monotherapy (Pre-Randomized)
Serious events: 870 serious events
Other events: 1287 other events
Deaths: 1040 deaths
Nivolumab Monotherapy (Total)
Serious events: 918 serious events
Other events: 1306 other events
Deaths: 1180 deaths
Serious adverse events
| Measure |
Cohort A: Nivolumab Monotherapy (Post-Randomization)
n=127 participants at risk
All participants that continued to receive treatment after completing 1 year (52 weeks) of nivolumab administered intravenously at 3 mg/kg every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent.
|
Cohort B: Nivolumab Monotherapy (Post-Randomization)
n=125 participants at risk
All participants that discontinued treatment after 1 year (52 weeks) of receiving nivolumab administered intravenously at 3 mg/kg every two weeks. Upon progression, participants can receive retreatment.
|
Nivolumab Monotherapy (Pre-Randomized)
n=1428 participants at risk
All Participants that received nivolumab administered intravenously at 3 mg/kg every two weeks for up to 1 year.
|
Nivolumab Monotherapy (Total)
n=1428 participants at risk
All Participants that received nivolumab administered intravenously at 3 mg/kg every two weeks regardless of continuation or discontinuation of treatment.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.6%
2/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.84%
12/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.91%
13/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.49%
7/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.49%
7/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.35%
5/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.35%
5/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.35%
5/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.35%
5/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Angina unstable
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Atrial fibrillation
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.84%
12/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.98%
14/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Atrial flutter
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.28%
4/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.35%
5/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Cardiac failure
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.28%
4/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.63%
9/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.70%
10/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.42%
6/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.49%
7/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.49%
7/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.56%
8/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Pericardial effusion
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.77%
11/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.84%
12/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.35%
5/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.35%
5/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Eye disorders
Ocular myasthenia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Eye disorders
Vision blurred
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.2%
17/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.3%
18/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Colitis
|
3.1%
4/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.49%
7/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.70%
10/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.56%
8/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.56%
8/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.91%
13/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.98%
14/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.56%
8/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.56%
8/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Enterocolonic fistula
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
2/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.35%
5/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Gastrointestinal angiectasia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.42%
6/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.42%
6/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Haematemesis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.28%
4/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.28%
4/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Nausea
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.84%
12/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.91%
13/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.28%
4/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.35%
5/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Vomiting
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.63%
9/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.70%
10/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Asthenia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.56%
8/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.56%
8/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Catheter site injury
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Chest pain
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.28%
4/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.28%
4/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Death
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.98%
14/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.98%
14/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Fatigue
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.63%
9/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.63%
9/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
General physical health deterioration
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Generalised oedema
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Infusion site extravasation
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Localised oedema
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Malaise
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.1%
15/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.1%
15/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Oedema peripheral
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Pain
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Physical deconditioning
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Pyrexia
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.6%
2/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.56%
8/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.56%
8/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Sudden death
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Hepatobiliary disorders
Autoimmune cholangitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Abscess oral
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Bacterial sepsis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Bronchitis
|
1.6%
2/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.28%
4/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.42%
6/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Cellulitis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.28%
4/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Clostridium difficile colitis
|
1.6%
2/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Cryptococcosis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Cystitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Device related infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Empyema
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Enterobacter pneumonia
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Escherichia sepsis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Groin infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Influenza
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Meningitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Otitis media
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Papilloma viral infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Pleural infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Pneumonia
|
13.4%
17/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.6%
7/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
8.3%
118/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
9.6%
137/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.56%
8/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.56%
8/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Pneumonia streptococcal
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Pyelonephritis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Sepsis
|
2.4%
3/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.6%
2/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.5%
22/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.8%
26/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Septic shock
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.28%
4/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Urinary tract infection
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.56%
8/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.63%
9/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Vascular device infection
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Wound infection staphylococcal
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Fall
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.28%
4/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.28%
4/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.28%
4/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.35%
5/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.35%
5/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Product administration error
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.28%
4/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Investigations
International normalised ratio increased
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Investigations
Troponin I increased
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Investigations
Troponin increased
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
2/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
2.3%
33/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
2.5%
35/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.56%
8/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.56%
8/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.63%
9/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.70%
10/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.35%
5/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.35%
5/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.6%
2/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.56%
8/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.70%
10/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.42%
6/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.42%
6/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.77%
11/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.84%
12/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.42%
6/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.42%
6/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.63%
9/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.70%
10/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.35%
5/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.35%
5/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.35%
5/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.42%
6/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Polymyositis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.49%
7/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.49%
7/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
8.7%
11/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
12.0%
15/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
35.6%
509/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
36.5%
521/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.42%
6/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.42%
6/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.63%
9/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.70%
10/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.42%
6/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.42%
6/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial effusion malignant
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Respiratory papilloma
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary malignancy
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Amnesia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Aphasia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Central nervous system haemorrhage
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Cerebellar stroke
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.63%
9/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.70%
10/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Depressed level of consciousness
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Dizziness
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Encephalopathy
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Headache
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Hemiparesis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Loss of consciousness
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Presyncope
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Seizure
|
1.6%
2/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.84%
12/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.98%
14/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.63%
9/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.63%
9/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Syncope
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.63%
9/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.77%
11/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Vocal cord paralysis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Product Issues
Device malfunction
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Psychiatric disorders
Confusional state
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.77%
11/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.84%
12/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Psychiatric disorders
Depression
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.63%
9/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.63%
9/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Psychiatric disorders
Psychotic disorder
|
1.6%
2/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.1%
15/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.1%
15/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Renal and urinary disorders
Dysuria
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.28%
4/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.28%
4/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Reproductive system and breast disorders
Adnexal torsion
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.6%
2/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.3%
18/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.3%
18/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.21%
3/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial fistula
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.6%
2/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.9%
5/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.6%
7/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.9%
27/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
2.2%
31/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.35%
5/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.35%
5/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
6.4%
91/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
6.4%
92/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.70%
10/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.70%
10/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.1%
16/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.2%
17/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.6%
2/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
2.6%
37/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
2.7%
38/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.6%
23/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.7%
24/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.70%
10/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.70%
10/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
2/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
2.8%
40/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.0%
43/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.28%
4/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.35%
5/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.5%
22/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.6%
23/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Vascular disorders
Aortic stenosis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Vascular disorders
Deep vein thrombosis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.1%
16/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.2%
17/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Vascular disorders
Embolism
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.49%
7/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.49%
7/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Vascular disorders
Haematoma
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Vascular disorders
Hypertension
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Vascular disorders
Hypotension
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.49%
7/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.49%
7/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.14%
2/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.07%
1/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.28%
4/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.28%
4/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
Other adverse events
| Measure |
Cohort A: Nivolumab Monotherapy (Post-Randomization)
n=127 participants at risk
All participants that continued to receive treatment after completing 1 year (52 weeks) of nivolumab administered intravenously at 3 mg/kg every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent.
|
Cohort B: Nivolumab Monotherapy (Post-Randomization)
n=125 participants at risk
All participants that discontinued treatment after 1 year (52 weeks) of receiving nivolumab administered intravenously at 3 mg/kg every two weeks. Upon progression, participants can receive retreatment.
|
Nivolumab Monotherapy (Pre-Randomized)
n=1428 participants at risk
All Participants that received nivolumab administered intravenously at 3 mg/kg every two weeks for up to 1 year.
|
Nivolumab Monotherapy (Total)
n=1428 participants at risk
All Participants that received nivolumab administered intravenously at 3 mg/kg every two weeks regardless of continuation or discontinuation of treatment.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.7%
11/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.6%
7/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
14.6%
208/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
15.5%
222/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Endocrine disorders
Hypothyroidism
|
6.3%
8/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.2%
4/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
9.0%
129/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
9.5%
136/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Abdominal pain
|
11.0%
14/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.6%
7/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
8.2%
117/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
9.3%
133/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Constipation
|
7.1%
9/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.8%
6/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
19.2%
274/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
20.3%
290/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Diarrhoea
|
28.3%
36/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
13.6%
17/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
19.3%
275/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
20.4%
292/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Nausea
|
17.3%
22/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
7.2%
9/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
23.2%
332/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
24.6%
352/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
15/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.0%
5/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
13.4%
191/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
14.5%
207/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Asthenia
|
3.9%
5/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.1%
73/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.5%
79/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Fatigue
|
20.5%
26/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
13.6%
17/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
36.1%
516/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
38.1%
544/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Non-cardiac chest pain
|
4.7%
6/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
2.4%
3/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.9%
84/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
6.6%
94/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Oedema peripheral
|
10.2%
13/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
7.2%
9/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
12.6%
180/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
13.8%
197/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
General disorders
Pyrexia
|
12.6%
16/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.6%
2/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
8.6%
123/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
10.0%
143/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Bronchitis
|
11.0%
14/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.0%
5/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.5%
50/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.5%
64/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Pneumonia
|
11.8%
15/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
11.2%
14/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
6.2%
89/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
7.1%
102/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Sinusitis
|
6.3%
8/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.2%
4/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.1%
59/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.6%
65/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Upper respiratory tract infection
|
22.0%
28/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
12.0%
15/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
9.0%
128/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
10.7%
153/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Infections and infestations
Urinary tract infection
|
9.4%
12/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
8.8%
11/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.2%
60/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.3%
75/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Injury, poisoning and procedural complications
Fall
|
8.7%
11/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
8.0%
10/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.8%
54/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.6%
65/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Investigations
Blood creatinine increased
|
13.4%
17/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.2%
4/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.6%
65/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.3%
76/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Investigations
Weight decreased
|
9.4%
12/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
16.0%
20/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
12.7%
182/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
13.4%
192/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Investigations
Weight increased
|
11.8%
15/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.2%
4/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
2.7%
39/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.4%
48/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.2%
18/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
10.4%
13/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
21.9%
313/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
23.5%
336/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
9/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
2.4%
3/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
8.9%
127/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
9.4%
134/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.5%
7/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.2%
4/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.3%
61/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.8%
68/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.6%
16/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
7.2%
9/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
8.8%
126/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
9.7%
138/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.0%
14/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
6.4%
8/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
10.4%
149/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
11.3%
162/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.9%
5/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.0%
5/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
6.8%
97/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
7.1%
102/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.6%
30/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
14.4%
18/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
19.9%
284/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
22.0%
314/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.4%
17/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
8.8%
11/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
13.2%
189/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
14.8%
211/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.7%
11/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.2%
4/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.1%
44/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.0%
57/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.9%
5/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
6.4%
8/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.2%
74/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.7%
82/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.1%
9/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.6%
2/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
6.3%
90/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
7.1%
102/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.3%
8/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.8%
6/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.2%
60/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.7%
67/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.1%
4/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.6%
7/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.1%
44/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.5%
50/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.4%
12/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
6.4%
8/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
7.1%
101/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
7.8%
112/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Dizziness
|
13.4%
17/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.6%
7/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
9.8%
140/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
10.9%
156/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Nervous system disorders
Headache
|
13.4%
17/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
6.4%
8/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
9.8%
140/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
11.3%
161/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Psychiatric disorders
Anxiety
|
5.5%
7/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
2.4%
3/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
6.7%
96/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
7.4%
106/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Psychiatric disorders
Depression
|
2.4%
3/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.0%
5/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.0%
71/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.3%
75/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Psychiatric disorders
Insomnia
|
11.8%
15/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.6%
7/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
9.0%
128/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
10.3%
147/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
9.4%
12/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
7.2%
9/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
2.9%
41/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.8%
54/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.3%
27/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
17.6%
22/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
21.1%
302/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
23.2%
331/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.0%
14/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
13.6%
17/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
23.7%
339/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
25.1%
359/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.9%
5/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
6.4%
8/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.7%
82/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
6.2%
88/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.7%
11/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.2%
4/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.4%
49/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.1%
58/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.3%
8/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.80%
1/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.6%
51/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.9%
55/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.9%
10/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.2%
4/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
2.3%
33/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
2.9%
42/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.7%
11/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.6%
7/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
6.6%
94/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
7.4%
105/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.3%
8/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
2.4%
3/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
1.5%
21/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
2.1%
30/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.7%
6/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.0%
5/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.0%
71/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.6%
80/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.4%
12/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.0%
5/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
8.3%
119/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
8.9%
127/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.9%
10/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.0%
5/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
6.9%
98/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
7.6%
108/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.3%
8/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.2%
4/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.3%
62/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.0%
72/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
5.5%
7/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
0.00%
0/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
2.6%
37/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
2.9%
42/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Vascular disorders
Hypertension
|
9.4%
12/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.8%
6/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
3.9%
56/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.5%
64/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
|
Vascular disorders
Hypotension
|
5.5%
7/127 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.0%
5/125 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
4.9%
70/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
5.5%
79/1428 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 90 months) . SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 88 months).
Post-Randomization indicates only data after randomization is summarized (applies to Cohort A and B). Pre-Randomized indicates only data before randomization is summarized (applies to all treated participants). Total indicates data is summarized throughout the full duration of the study (applies to all treated participants).
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER