Trial Outcomes & Findings for Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide-based Therapy in the First or Second Line Setting (NCT NCT01946477)
NCT ID: NCT01946477
Last Updated: 2026-05-22
Results Overview
ORR per Modified International Myeloma Working Group (mIMWG) Criteria is defined as the percentage of participants who achieve best overall response of Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR). CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level \< 100 mg per 24 hours PR=≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
186 participants
Primary outcome timeframe
From first dose until disease progression or end of treatment whichever occurs first (Up to 130 months)
Results posted on
2026-05-22
Participant Flow
Participant milestones
| Measure |
Cohort A
(Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
|
Cohort B
(Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
Cohort C
(Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
|---|---|---|---|
|
Overall Study
STARTED
|
56
|
112
|
18
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
56
|
112
|
18
|
Reasons for withdrawal
| Measure |
Cohort A
(Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
|
Cohort B
(Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
Cohort C
(Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
|---|---|---|---|
|
Overall Study
Progressive Disease
|
32
|
53
|
7
|
|
Overall Study
Other reasons
|
4
|
7
|
6
|
|
Overall Study
Withdrawal by Subject
|
8
|
23
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
0
|
|
Overall Study
Adverse Event
|
8
|
10
|
3
|
|
Overall Study
Death
|
2
|
4
|
0
|
|
Overall Study
Transition to commercially available treatment
|
0
|
4
|
1
|
|
Overall Study
Study terminated by sponsor
|
0
|
10
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
Baseline Characteristics
Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide-based Therapy in the First or Second Line Setting
Baseline characteristics by cohort
| Measure |
Cohort A
n=56 Participants
(Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
|
Cohort B
n=112 Participants
(Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
Cohort C
n=18 Participants
(Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=2 Participants
|
50 Participants
n=4 Participants
|
6 Participants
n=6 Participants
|
77 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=2 Participants
|
62 Participants
n=4 Participants
|
12 Participants
n=6 Participants
|
109 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=2 Participants
|
36 Participants
n=4 Participants
|
4 Participants
n=6 Participants
|
64 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=2 Participants
|
76 Participants
n=4 Participants
|
14 Participants
n=6 Participants
|
122 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
9 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=2 Participants
|
109 Participants
n=4 Participants
|
18 Participants
n=6 Participants
|
177 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=2 Participants
|
6 Participants
n=4 Participants
|
18 Participants
n=6 Participants
|
28 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=2 Participants
|
10 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
13 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=2 Participants
|
91 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
138 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=2 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
6 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From first dose until disease progression or end of treatment whichever occurs first (Up to 130 months)Population: All treated participants
ORR per Modified International Myeloma Working Group (mIMWG) Criteria is defined as the percentage of participants who achieve best overall response of Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR). CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level \< 100 mg per 24 hours PR=≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours
Outcome measures
| Measure |
Cohort A
n=56 Participants
(Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
|
Cohort B
n=112 Participants
(Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
Cohort C
n=18 Participants
(Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
|---|---|---|---|
|
Overall Response Rate (ORR)
|
32.1 Percentage of participants
|
79.5 Percentage of participants
|
94.4 Percentage of participants
|
SECONDARY outcome
Timeframe: From first dose until the first documented disease progression, or death whichever occurs first (Up to 130 months)Population: All treated participants
PFS is defined as the time from the first dose to the first documentation of disease progression according to modified International Myeloma Working Group (mIMWG) criteria or death from any cause, whichever occurs first. Disease Progression=Increase or reappearance of monoclonal protein in serum or urine meeting mIMWG progression thresholds; Increase in bone marrow plasma cell percentage consistent with disease progression; Development of new or worsening lytic bone lesions; Progressive or newly enlarging extramedullary plasmacytomas. Based on Kaplan-Meier Estimates.
Outcome measures
| Measure |
Cohort A
n=56 Participants
(Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
|
Cohort B
n=112 Participants
(Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
Cohort C
n=18 Participants
(Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
9.5 Months
Interval 6.2 to 15.2
|
26.4 Months
Interval 18.7 to 46.5
|
NA Months
Interval 18.6 to
insufficient number of participants with event to calculate upper limit and median per K-M methodology
|
SECONDARY outcome
Timeframe: From first dose until death due to any cause (Up to 130 months)Population: All treated participants
OS is defined as the time from start of treatment until the time of death from any cause. If no death is recorded the subject will be censored at the time the subject was last known to be alive. Based on Kaplan-Meier Estimates
Outcome measures
| Measure |
Cohort A
n=56 Participants
(Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
|
Cohort B
n=112 Participants
(Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
Cohort C
n=18 Participants
(Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
|---|---|---|---|
|
Overall Survival (OS)
|
38.2 Months
Interval 26.1 to 55.8
|
56.7 Months
Interval 43.6 to
insufficient number of participants with event to calculate upper limit per K-M methodology
|
NA Months
Interval 26.2 to
insufficient number of participants with event to calculate upper limit or median per K-M methodology
|
SECONDARY outcome
Timeframe: From first dose until the first documented disease progression, or death whichever occurs first (Up to 130 months)Population: All responders (PR, VGPR, CR)
DoR is defined as thr time from the initial documented response (partial response or better) to the first confirmed progressive disease or until death from any cause. Participants without documented progression will be censored at the time of their last response assessment. CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level \< 100 mg per 24 hours PR=≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours. Based on Kaplan-Meier Estimates
Outcome measures
| Measure |
Cohort A
n=18 Participants
(Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
|
Cohort B
n=89 Participants
(Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
Cohort C
n=17 Participants
(Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
|---|---|---|---|
|
Duration of Response (DoR)
|
30.2 Months
Interval 6.8 to
Insufficient number of participants with event to calculate upper limit
|
35.3 Months
Interval 22.4 to 52.5
|
NA Months
Interval 26.3 to
Insufficient number of participants with event to calculate upper limit and median
|
SECONDARY outcome
Timeframe: From first dose until the first documented response (Up to 130 months)Population: All responders (PR, VGPR, CR)
TTR is defined as the time from the start of treatment to the first documented response (Partial Response, Very Good Partial Response or Complete Response) based on according to modified International Myeloma Working Group (mIMWG) criteria. CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level \< 100 mg per 24 hours PR=≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours. Based on Kaplan-Meier Estimates
Outcome measures
| Measure |
Cohort A
n=18 Participants
(Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
|
Cohort B
n=89 Participants
(Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
Cohort C
n=17 Participants
(Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
|---|---|---|---|
|
Time to Response (TTR)
|
1.9 Months
Interval 0.9 to 12.8
|
1.0 Months
Interval 0.8 to 4.8
|
1.2 Months
Interval 1.0 to 9.0
|
SECONDARY outcome
Timeframe: From first dose until the first documented disease progression whichever occurs first (Up to 130 months)Population: All treated participants
TTP is defined as the time from start of treatment until Progressive Disease (as determined by the site investigator according to modified International Myeloma Working Group (mIMWG) criteria). Participants not experiencing a documented progression will be censored at the time of their last response assessment. Disease Progression=Increase or reappearance of monoclonal protein in serum or urine meeting mIMWG progression thresholds; Increase in bone marrow plasma cell percentage consistent with disease progression; Development of new or worsening lytic bone lesions; Progressive or newly enlarging extramedullary plasmacytomas. Based on Kaplan-Meier Estimates
Outcome measures
| Measure |
Cohort A
n=56 Participants
(Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
|
Cohort B
n=112 Participants
(Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
Cohort C
n=18 Participants
(Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
|---|---|---|---|
|
Time to Progression (TTP)
|
12.2 Months
Interval 7.9 to 28.5
|
34.5 Months
Interval 23.5 to 57.7
|
NA Months
Interval 18.6 to
Insufficient number of participants with events to calculate median and upper limit
|
SECONDARY outcome
Timeframe: From first dose until 28 days post last dose (Up to 120 months)Population: All treated participants
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.
Outcome measures
| Measure |
Cohort A
n=56 Participants
(Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
|
Cohort B
n=112 Participants
(Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
Cohort C
n=18 Participants
(Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs)
Second primary malignancies
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs)
TEAE
|
56 Participants
|
112 Participants
|
18 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs)
TEAE related to Pomalidomide
|
40 Participants
|
105 Participants
|
17 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs)
TEAE related to Dexamethasone
|
34 Participants
|
86 Participants
|
18 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs)
TEAE related to Daratumumab
|
0 Participants
|
90 Participants
|
18 Participants
|
Adverse Events
Cohort A
Serious events: 30 serious events
Other events: 56 other events
Deaths: 31 deaths
Cohort B
Serious events: 69 serious events
Other events: 112 other events
Deaths: 51 deaths
Cohort C
Serious events: 11 serious events
Other events: 18 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Cohort A
n=56 participants at risk
(Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
|
Cohort B
n=112 participants at risk
(Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
Cohort C
n=18 participants at risk
(Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Blood and lymphatic system disorders
Atypical haemolytic uraemic syndrome
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
9.8%
11/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
4.5%
5/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Cardiac disorders
Cardiac arrest
|
3.6%
2/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Cardiac disorders
Cardiac failure congestive
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Cardiac disorders
Cardiovascular deconditioning
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Eye disorders
Cataract
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
22.2%
4/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Gastrointestinal disorders
Enterovesical fistula
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Vascular disorders
Embolism
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Gastrointestinal disorders
Intestinal perforation
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
General disorders and administration site conditions
Asthenia
|
3.6%
2/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
General disorders and administration site conditions
General physical health deterioration
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
General disorders and administration site conditions
Influenza like illness
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
General disorders and administration site conditions
Multiple organ dysfunction syndrome
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
General disorders and administration site conditions
Pyrexia
|
7.1%
4/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
General disorders and administration site conditions
Sudden death
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Abscess
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Abscess limb
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Bronchitis
|
3.6%
2/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
COVID-19
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.1%
2/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Cerebral toxoplasmosis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Cytomegalovirus chorioretinitis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Diverticulitis
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Encephalitis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Gastrointestinal infection
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
HCoV-NL63 infection
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Influenza
|
7.1%
4/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
2.7%
3/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Listeriosis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
2.7%
3/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Meningitis listeria
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Neutropenic sepsis
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
4.5%
5/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
3.6%
4/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Pneumonia
|
14.3%
8/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
16.1%
18/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
22.2%
4/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Polyomavirus-associated nephropathy
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
2.7%
3/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Sepsis
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
3.6%
4/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Septic shock
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Streptococcal bacteraemia
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Urinary tract infection
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Varicella zoster virus infection
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Viral diarrhoea
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Viral infection
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Injury, poisoning and procedural complications
Drain site complication
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Investigations
International normalised ratio increased
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Investigations
Liver function test increased
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Metabolism and nutrition disorders
Gout
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma malignant
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell type acute leukaemia
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
6.2%
7/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mucinous adenocarcinoma of appendix
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
3.6%
4/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Nervous system disorders
Basal ganglia infarction
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
2.7%
3/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Nervous system disorders
Postictal paralysis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Nervous system disorders
Syncope
|
3.6%
2/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Nervous system disorders
Transient ischaemic attack
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Psychiatric disorders
Confusional state
|
3.6%
2/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Psychiatric disorders
Mental status changes
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Renal and urinary disorders
Acute kidney injury
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Renal and urinary disorders
Bladder tamponade
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Renal and urinary disorders
Haematuria
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Renal and urinary disorders
Pneumaturia
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Renal and urinary disorders
Renal failure
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
3.6%
4/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
2.7%
3/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.6%
2/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
4.5%
5/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Vascular disorders
Deep vein thrombosis
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Vascular disorders
Embolism venous
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Vascular disorders
Hypertension
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
Other adverse events
| Measure |
Cohort A
n=56 participants at risk
(Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
|
Cohort B
n=112 participants at risk
(Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
Cohort C
n=18 participants at risk
(Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
37.5%
21/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
29.5%
33/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
27.8%
5/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
3.6%
4/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
10.7%
12/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
33.3%
6/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Nervous system disorders
Headache
|
19.6%
11/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
19.6%
22/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
22.2%
4/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.2%
13/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
67.0%
75/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
77.8%
14/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.1%
9/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
25.9%
29/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
22.2%
4/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
4/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.4%
6/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Cardiac disorders
Tachycardia
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
2.7%
3/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Endocrine disorders
Cushingoid
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Eye disorders
Cataract
|
8.9%
5/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
13.4%
15/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
38.9%
7/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Eye disorders
Conjunctival haemorrhage
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
2.7%
3/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Eye disorders
Dry eye
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
3.6%
4/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.1%
2/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Eye disorders
Retinal tear
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.1%
2/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Eye disorders
Vision blurred
|
7.1%
4/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
6.2%
7/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
7/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
10.7%
12/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Gastrointestinal disorders
Constipation
|
25.0%
14/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
20.5%
23/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
33.3%
6/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.1%
2/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
26.8%
15/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
42.9%
48/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
16.7%
3/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Gastrointestinal disorders
Dry mouth
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Psychiatric disorders
Agitation
|
8.9%
5/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
4.5%
5/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Psychiatric disorders
Anxiety
|
12.5%
7/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.6%
13/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Gastrointestinal disorders
Dyspepsia
|
10.7%
6/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
8.0%
9/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Gastrointestinal disorders
Dysphagia
|
3.6%
2/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.4%
6/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.7%
6/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
10.7%
12/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Gastrointestinal disorders
Nausea
|
25.0%
14/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
38.4%
43/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
8.0%
9/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
7/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
19.6%
22/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
General disorders and administration site conditions
Asthenia
|
23.2%
13/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
7.1%
8/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
General disorders and administration site conditions
Pain
|
10.7%
6/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
4.5%
5/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
General disorders and administration site conditions
Catheter site pain
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
General disorders and administration site conditions
Chills
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
8.9%
10/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Vascular disorders
Embolism
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
General disorders and administration site conditions
Fatigue
|
39.3%
22/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
50.9%
57/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
16.7%
3/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
General disorders and administration site conditions
Gait disturbance
|
10.7%
6/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
COVID-19
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
3.6%
4/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
General disorders and administration site conditions
Influenza like illness
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
17.9%
20/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
General disorders and administration site conditions
Malaise
|
8.9%
5/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.1%
2/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
7.1%
4/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
8.0%
9/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
General disorders and administration site conditions
Oedema
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
General disorders and administration site conditions
Oedema peripheral
|
25.0%
14/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
27.7%
31/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
22.2%
4/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
General disorders and administration site conditions
Peripheral swelling
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
7.1%
8/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
General disorders and administration site conditions
Pyrexia
|
23.2%
13/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
22.3%
25/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
33.3%
6/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
2.7%
3/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.1%
2/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Acute sinusitis
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Bronchitis
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
6.2%
7/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Cellulitis
|
3.6%
2/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
6.2%
7/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Conjunctivitis
|
3.6%
2/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.4%
6/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Cystitis bacterial
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.1%
2/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Diverticulitis
|
3.6%
2/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Ear infection
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
2.7%
3/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Empyema
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Folliculitis
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Herpes zoster
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
2.7%
3/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.1%
2/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Hordeolum
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
2.7%
3/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Influenza
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
8.9%
10/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.1%
2/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
4/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
13.4%
15/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
16.7%
3/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Parainfluenzae virus infection
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
3.6%
4/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Paronychia
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Periodontitis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Pneumonia
|
10.7%
6/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
24.1%
27/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Scabies
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Sinusitis
|
3.6%
2/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
12.5%
14/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Systemic mycosis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Tinea infection
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
21.4%
12/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
36.6%
41/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
16.7%
3/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Urinary tract infection
|
3.6%
2/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
9.8%
11/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Infections and infestations
Varicella zoster virus infection
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Injury, poisoning and procedural complications
Compression fracture
|
7.1%
4/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
4.5%
5/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Injury, poisoning and procedural complications
Contusion
|
7.1%
4/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
17.0%
19/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Injury, poisoning and procedural complications
Fall
|
10.7%
6/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
18.8%
21/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
30.4%
34/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
27.8%
5/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Injury, poisoning and procedural complications
Scratch
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Investigations
Alanine aminotransferase increased
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
6.2%
7/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
16.7%
3/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Investigations
Aspartate aminotransferase increased
|
3.6%
2/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
4.5%
5/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.1%
2/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Investigations
Blood creatinine increased
|
12.5%
7/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.6%
13/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Investigations
Cytomegalovirus test positive
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.1%
2/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Investigations
International normalised ratio increased
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
3.6%
4/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Investigations
Neutrophil count decreased
|
3.6%
2/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
19.6%
22/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Investigations
Platelet count decreased
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
15.2%
17/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Investigations
Weight decreased
|
8.9%
5/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
10.7%
12/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Investigations
Weight increased
|
8.9%
5/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
8.9%
10/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Investigations
White blood cell count decreased
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
14.3%
16/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.9%
10/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
13.4%
15/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
8.9%
5/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
6.2%
7/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
10.7%
6/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
4.5%
5/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.1%
4/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
8.9%
10/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.1%
2/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.1%
4/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.4%
6/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
10.7%
12/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
17.9%
10/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
21.4%
24/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.1%
4/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.6%
13/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.1%
2/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.6%
13/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
14.3%
16/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
16.7%
3/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
1.8%
2/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.9%
10/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
33.0%
37/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.1%
2/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
2.7%
3/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.2%
13/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
27.7%
31/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
16.7%
3/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.1%
4/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
15.2%
17/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.1%
9/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
23.2%
26/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.1%
2/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.6%
13/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
10.7%
6/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
12.5%
14/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
4.5%
5/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.6%
2/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
10.7%
12/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
3.6%
4/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.7%
6/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
7.1%
8/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.7%
6/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
17.0%
19/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Nervous system disorders
Diplegia
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Nervous system disorders
Dizziness
|
28.6%
16/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
17.9%
20/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Nervous system disorders
Hypoaesthesia
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
6.2%
7/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
16.1%
18/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.1%
2/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Nervous system disorders
Syncope
|
8.9%
5/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
3.6%
4/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Nervous system disorders
Tension headache
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Nervous system disorders
Tremor
|
10.7%
6/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
12.5%
14/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Psychiatric disorders
Confusional state
|
10.7%
6/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
4.5%
5/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Psychiatric disorders
Insomnia
|
21.4%
12/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
23.2%
26/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
16.7%
3/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Psychiatric disorders
Mood swings
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
2.7%
3/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Renal and urinary disorders
Dysuria
|
7.1%
4/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
4.5%
5/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Renal and urinary disorders
Haematuria
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
3.6%
4/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Renal and urinary disorders
Pollakiuria
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.4%
6/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Renal and urinary disorders
Urinary incontinence
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
2.7%
3/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.4%
6/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.6%
11/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
42.0%
47/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
35.7%
20/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
36.6%
41/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.1%
4/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
10.7%
12/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
4/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
9.8%
11/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.6%
2/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
2.7%
3/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.1%
2/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
8.9%
10/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.7%
6/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
22.3%
25/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
4/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
16.1%
18/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.9%
5/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
18.8%
21/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.6%
2/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
17.9%
20/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
4.5%
5/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
8.9%
10/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.9%
5/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
4.5%
5/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
4.5%
5/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
4/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
8.0%
9/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.1%
2/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
7/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
17.9%
20/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
33.3%
6/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.4%
6/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
3.6%
2/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.4%
6/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Vascular disorders
Flushing
|
1.8%
1/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
6.2%
7/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Vascular disorders
Haematoma
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.4%
6/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Vascular disorders
Hot flush
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.00%
0/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Vascular disorders
Hypertension
|
5.4%
3/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
14.3%
16/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Vascular disorders
Hypotension
|
7.1%
4/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
9.8%
11/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
11.1%
2/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
|
Vascular disorders
Peripheral vein thrombosis
|
0.00%
0/56 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
0.89%
1/112 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
5.6%
1/18 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
|
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