Trial Outcomes & Findings for Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (NCT NCT01734928)
NCT ID: NCT01734928
Last Updated: 2023-06-06
Results Overview
Progression free survival (PFS) will be calculated as the time between the randomization and progressive disease (PD) or death. Progressive Disease is defined as an Increase of ≥ 25% from nadir in: * Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL)g * Urine M-component and/or (the absolute increase must be ≥ 200 mg/24 hours) * In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels, the absolute increase must be \> 100 mg/dL. * Bone marrow plasma cell percentage, the absolute % must be ≥ 10%h * Definite development of new bone lesions or soft tissue plasmacytomas increase in the size of existing bone lesions or soft tissue plasmacytomas. -Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
559 participants
Primary outcome timeframe
From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
Results posted on
2023-06-06
Participant Flow
548 participants treated
Participant milestones
| Measure |
Treatment 1: POM+BTZ+LD-DEX
POM (Pomalidomide)
* 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
Treatment 2: BTZ+LD-DEX
BTZ ((Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
|---|---|---|
|
Randomization
STARTED
|
281
|
278
|
|
Randomization
COMPLETED
|
278
|
270
|
|
Randomization
NOT COMPLETED
|
3
|
8
|
|
Treatment Period
STARTED
|
278
|
270
|
|
Treatment Period
COMPLETED
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
278
|
270
|
Reasons for withdrawal
| Measure |
Treatment 1: POM+BTZ+LD-DEX
POM (Pomalidomide)
* 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
Treatment 2: BTZ+LD-DEX
BTZ ((Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
|---|---|---|
|
Randomization
Physician Decision
|
0
|
1
|
|
Randomization
clinical progression
|
0
|
1
|
|
Randomization
progressive disease
|
0
|
2
|
|
Randomization
Withdrew informed consent
|
0
|
4
|
|
Randomization
Death
|
1
|
0
|
|
Randomization
Randomization error
|
1
|
0
|
|
Randomization
Lost to Follow-up
|
1
|
0
|
|
Treatment Period
Lost to Follow-up
|
0
|
2
|
|
Treatment Period
Progressive Disease
|
167
|
165
|
|
Treatment Period
Adverse Event
|
39
|
52
|
|
Treatment Period
Withdrawal of Consent
|
25
|
22
|
|
Treatment Period
Death
|
20
|
9
|
|
Treatment Period
Other Reasons
|
27
|
19
|
|
Treatment Period
Pregnancy
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Treatment 1: POM+BTZ+LD-DEX
n=281 Participants
POM (Pomalidomide)
* 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
Treatment 2: BTZ+LD-DEX
n=278 Participants
BTZ ((Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
Total
n=559 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 Years
STANDARD_DEVIATION 10.13 • n=5 Participants
|
66.1 Years
STANDARD_DEVIATION 10.16 • n=7 Participants
|
66.0 Years
STANDARD_DEVIATION 10.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
126 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
257 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
155 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
244 Participants
n=5 Participants
|
241 Participants
n=7 Participants
|
485 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
237 Participants
n=5 Participants
|
234 Participants
n=7 Participants
|
471 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 monthsPopulation: All randomized participants
Progression free survival (PFS) will be calculated as the time between the randomization and progressive disease (PD) or death. Progressive Disease is defined as an Increase of ≥ 25% from nadir in: * Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL)g * Urine M-component and/or (the absolute increase must be ≥ 200 mg/24 hours) * In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels, the absolute increase must be \> 100 mg/dL. * Bone marrow plasma cell percentage, the absolute % must be ≥ 10%h * Definite development of new bone lesions or soft tissue plasmacytomas increase in the size of existing bone lesions or soft tissue plasmacytomas. -Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.
Outcome measures
| Measure |
Treatment 1: POM+BTZ+LD-DEX
n=281 Participants
POM (Pomalidomide)
* 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
Treatment 2: BTZ+LD-DEX
n=278 Participants
BTZ ((Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
|---|---|---|
|
Progression Free Survival by Independent Response Adjudication Committee (IRAC)
|
11.20 Months
Interval 9.66 to 13.73
|
7.10 Months
Interval 5.88 to 8.48
|
SECONDARY outcome
Timeframe: From randomization to date of death, up to approximately 65 monthsPopulation: All randomized participants
Overall survival (OS) is calculated as the time from randomization to death from any cause.
Outcome measures
| Measure |
Treatment 1: POM+BTZ+LD-DEX
n=281 Participants
POM (Pomalidomide)
* 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
Treatment 2: BTZ+LD-DEX
n=278 Participants
BTZ ((Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
|---|---|---|
|
Overall Survival (OS)
|
35.58 Months
Interval 28.55 to 41.2
|
31.61 Months
Interval 26.05 to 37.16
|
SECONDARY outcome
Timeframe: From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 monthsPopulation: All randomized participants
The ORR together with the relative proportions in each response category (ie, stringent CR \[sCR\], CR, very good PR \[VGPR\], PR, SD, and PD) by treatment using the IMWG criteria will be examined. Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence 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 Progressive Disease: Please refer to Primary outcome measure for definition SD: Not meeting criteria for CR, VGPR, PR, or progressive disease
Outcome measures
| Measure |
Treatment 1: POM+BTZ+LD-DEX
n=281 Participants
POM (Pomalidomide)
* 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
Treatment 2: BTZ+LD-DEX
n=278 Participants
BTZ ((Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
|---|---|---|
|
Overall Response Rate by Independent Response Adjudication Committee (IRAC)
Stringent complete response
|
9 Participants
|
2 Participants
|
|
Overall Response Rate by Independent Response Adjudication Committee (IRAC)
Complete Reponse
|
35 Participants
|
9 Participants
|
|
Overall Response Rate by Independent Response Adjudication Committee (IRAC)
Very Good Partial Response
|
104 Participants
|
40 Participants
|
|
Overall Response Rate by Independent Response Adjudication Committee (IRAC)
Partial Response
|
83 Participants
|
88 Participants
|
|
Overall Response Rate by Independent Response Adjudication Committee (IRAC)
Stable Disease
|
32 Participants
|
106 Participants
|
|
Overall Response Rate by Independent Response Adjudication Committee (IRAC)
Progressive Disease
|
11 Participants
|
16 Participants
|
|
Overall Response Rate by Independent Response Adjudication Committee (IRAC)
Not Evaluable
|
7 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 monthsPopulation: All randomized participants with a response (sCR or CR or VGPR or PR)
Duration of myeloma response is defined as the duration from the time when the IMWG response criteria are first met for sCR or CR or VGPR or PR until the first date the response criteria are met for PD or until the subject died from any cause, whichever occurs first. Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence 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 Progressive Disease: Please refer to Primary outcome measure for definition SD: Not meeting criteria for CR, VGPR, PR, or progressive disease
Outcome measures
| Measure |
Treatment 1: POM+BTZ+LD-DEX
n=231 Participants
POM (Pomalidomide)
* 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
Treatment 2: BTZ+LD-DEX
n=139 Participants
BTZ ((Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
|---|---|---|
|
Duration of Response by Independent Response Adjudication Committee (IRAC)
|
13.70 Months
Interval 10.94 to 18.1
|
10.94 Months
Interval 8.11 to 14.78
|
SECONDARY outcome
Timeframe: From first dose to 28 days after the last dose (up to approximately 44 monthsPopulation: All Treated Participants
Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.
Outcome measures
| Measure |
Treatment 1: POM+BTZ+LD-DEX
n=278 Participants
POM (Pomalidomide)
* 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
Treatment 2: BTZ+LD-DEX
n=270 Participants
BTZ ((Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
|---|---|---|
|
Number of Participants With Grade 3-4 Treatment Emergent Adverse Events (TEAE)
|
259 Participants
|
194 Participants
|
SECONDARY outcome
Timeframe: From first dose to 28 days after the last dose (up to approximately 44 monthsPopulation: All Treated Participants
Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.
Outcome measures
| Measure |
Treatment 1: POM+BTZ+LD-DEX
n=278 Participants
POM (Pomalidomide)
* 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
Treatment 2: BTZ+LD-DEX
n=270 Participants
BTZ ((Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
|---|---|---|
|
Number of Participants With Grade 5 Treatment Emergent Adverse Events (TEAE)
|
29 Participants
|
12 Participants
|
Adverse Events
Treatment 1: POM + BTZ + LD-DEX
Serious events: 177 serious events
Other events: 276 other events
Deaths: 197 deaths
Treatment 2: BTZ + LD-DEX
Serious events: 119 serious events
Other events: 260 other events
Deaths: 193 deaths
Serious adverse events
| Measure |
Treatment 1: POM + BTZ + LD-DEX
n=278 participants at risk
POM (Pomalidomide)
* 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
Treatment 2: BTZ + LD-DEX
n=270 participants at risk
BTZ ((Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
4/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.9%
5/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.8%
5/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Hyperviscosity syndrome
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
3/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
3/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Acute coronary syndrome
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Acute myocardial infarction
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Angina pectoris
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Angina unstable
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
9/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.74%
2/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrial flutter
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrial thrombosis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Bradycardia
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Bundle branch block left
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac arrest
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac failure
|
1.1%
3/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.74%
2/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
3/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.74%
2/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Coronary artery disease
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Myocardial infarction
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Pericarditis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Sinus bradycardia
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Sinus node dysfunction
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Ear and labyrinth disorders
Vertigo
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Cataract
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Retinal detachment
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Retinal vein thrombosis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Colonic fistula
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.74%
2/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
5/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
6/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Enterocolitis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastric volvulus
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Ileus
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
3/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
3/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Death
|
1.4%
4/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Fatigue
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Gait disturbance
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.74%
2/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
General physical health deterioration
|
1.8%
5/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.3%
9/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Influenza like illness
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Malaise
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.74%
2/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Non-cardiac chest pain
|
1.1%
3/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.74%
2/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pain
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
4.3%
12/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.9%
5/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholecystitis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Abscess limb
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Acute hepatitis B
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bacterial sepsis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bronchiolitis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bronchitis
|
1.1%
3/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.74%
2/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bronchitis bacterial
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bronchitis pneumococcal
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Catheter site infection
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Cellulitis
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Clostridium difficile colitis
|
1.4%
4/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Clostridium difficile infection
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Device related infection
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Diverticulitis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Endocarditis
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Enterobacter pneumonia
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Epididymitis
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Erysipelas
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Escherichia sepsis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Escherichia urinary tract infection
|
1.1%
3/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
H1N1 influenza
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Herpes oesophagitis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Herpes zoster
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Hordeolum
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Infection
|
1.1%
3/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Influenza
|
3.6%
10/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
4/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Leishmaniasis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Localised infection
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Lower respiratory tract infection
|
3.6%
10/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.9%
5/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Lung infection
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.74%
2/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Meningitis listeria
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Meningococcal infection
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Muscle abscess
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Neutropenic sepsis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Oesophageal candidiasis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Osteomyelitis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pharyngitis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumococcal sepsis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
12.2%
34/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.3%
17/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia bacterial
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia influenzal
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia legionella
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia moraxella
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.74%
2/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia streptococcal
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.74%
2/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pulmonary sepsis
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Respiratory tract infection
|
1.8%
5/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Respiratory tract infection viral
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Rhinovirus infection
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sepsis
|
1.8%
5/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Septic shock
|
2.2%
6/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sinusitis
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Skin infection
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Staphylococcal sepsis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Streptococcal sepsis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
3/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
3/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
1.1%
3/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urosepsis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.74%
2/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
3/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Aspartate aminotransferase increased
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood alkaline phosphatase increased
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatinine increased
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Chest X-ray abnormal
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Coronavirus test positive
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
General physical condition abnormal
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
International normalised ratio increased
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Neutrophil count decreased
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
3/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.74%
2/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.1%
3/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
3/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Osteorrhagia
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.74%
2/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.2%
6/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell leukaemia
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Porocarcinoma
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Scrotal cancer
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
1.4%
4/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.74%
2/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Amnesia
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Aphasia
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cerebrovascular accident
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cognitive disorder
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dizziness
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Encephalopathy
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Epilepsy
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Motor dysfunction
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Nerve root compression
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Paraparesis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Paraplegia
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Presyncope
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Spinal cord compression
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.74%
2/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Syncope
|
2.2%
6/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.9%
5/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Transient ischaemic attack
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Anxiety
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Confusional state
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Depression
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
2.9%
8/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
6/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Anuria
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Renal colic
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Urinary retention
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.1%
3/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
4/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
3/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
3/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.2%
9/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.72%
2/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.74%
2/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Deep vein thrombosis
|
1.4%
4/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
4/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertension
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypotension
|
1.1%
3/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Orthostatic hypotension
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.36%
1/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Other adverse events
| Measure |
Treatment 1: POM + BTZ + LD-DEX
n=278 participants at risk
POM (Pomalidomide)
* 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
Treatment 2: BTZ + LD-DEX
n=270 participants at risk
BTZ ((Bortezomib)
* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle
* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)
* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
31.3%
87/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
26.7%
72/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.3%
37/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.3%
9/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.0%
14/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.3%
9/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
54.0%
150/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.7%
29/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
39.6%
110/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
38.9%
105/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrial fibrillation
|
9.4%
26/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.9%
5/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Cataract
|
7.9%
22/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
3/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Vision blurred
|
5.0%
14/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.3%
9/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal distension
|
6.1%
17/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
6/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
10.8%
30/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.0%
19/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
23/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
16/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
38.1%
106/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
24.1%
65/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
36.7%
102/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
30.4%
82/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dry mouth
|
6.8%
19/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.1%
11/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dyspepsia
|
7.9%
22/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.3%
25/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
18.7%
52/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.7%
56/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Stomatitis
|
6.1%
17/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
1/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
12.6%
35/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
27/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
18.7%
52/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.8%
48/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Fatigue
|
38.5%
107/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
26.7%
72/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Influenza like illness
|
5.4%
15/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.3%
9/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Oedema peripheral
|
36.3%
101/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
54/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
25.9%
72/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.2%
33/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bronchitis
|
15.5%
43/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
20/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Conjunctivitis
|
9.4%
26/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
16/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Influenza
|
9.7%
27/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
13/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Lower respiratory tract infection
|
6.1%
17/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.0%
8/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
9.4%
26/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.8%
21/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Respiratory tract infection
|
7.6%
21/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
16/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
25.5%
71/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
18.9%
51/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
12.9%
36/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.4%
28/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Viral upper respiratory tract infection
|
12.9%
36/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
18/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
12.6%
35/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.1%
11/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Fall
|
7.2%
20/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.1%
11/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
14/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
3/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Weight decreased
|
7.2%
20/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
18/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Weight increased
|
6.8%
19/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.0%
19/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.4%
29/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.6%
26/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
15.5%
43/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.4%
28/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.2%
20/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
10/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.2%
45/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.5%
31/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.2%
20/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
7/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.2%
20/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
10/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.0%
39/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.9%
32/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.9%
61/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.1%
38/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.0%
25/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.2%
14/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.8%
30/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
16/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
14.7%
41/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.4%
12/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
23/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.3%
17/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.4%
15/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.1%
11/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.1%
42/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.1%
38/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dizziness
|
17.6%
49/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.7%
29/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dysgeusia
|
6.5%
18/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.0%
8/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
12.6%
35/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.3%
25/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Hypoaesthesia
|
2.5%
7/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.6%
15/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Paraesthesia
|
6.5%
18/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.9%
5/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
6.5%
18/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.4%
12/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
48.2%
134/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
38.1%
103/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Syncope
|
5.0%
14/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
6/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Tremor
|
11.5%
32/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.0%
8/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Anxiety
|
4.7%
13/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.3%
17/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Depression
|
5.8%
16/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
7/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Insomnia
|
17.6%
49/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
54/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.7%
66/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
45/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.3%
62/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.9%
32/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.1%
17/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
16/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.1%
17/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
13/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.2%
31/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.1%
11/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertension
|
8.6%
24/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.1%
22/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypotension
|
9.4%
26/278 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
13/270 • AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
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
- Publication restrictions are in place
Restriction type: LTE60