Trial Outcomes & Findings for An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma (NCT NCT02726581)
NCT ID: NCT02726581
Last Updated: 2023-03-27
Results Overview
Randomization to first documented tumor progression or death due to any cause, whichever occurred first. Participants who die without reported prior progression are considered to have progressed on date of their death. Participants who did not progress or die will be censored at their last efficacy assessment. Participants who did not have on study efficacy assessments and alive will be censored on randomization date. Participants who started subsequent anti-cancer therapy without prior reported progression will be censored at last efficacy assessment prior to subsequent anti-cancer therapy. Progression is 1) increase of 25% from lowest confirmed response value in specific Serum M-protein and Urine M-protein criteria and increase of FLC for patients with no measurable M protein in blood or urine at baseline and/or 2) appearance of a new lesion(s), \>/= 50% increase from nadir in SPD of \> 1 lesion, or \>/= 50% increase in the longest diameter of a previous lesion \> 1 cm in short axis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
170 participants
Primary outcome timeframe
From randomization to the date of the first documented tumor progression or death due to any cause, whichever occurred first (Up to approximately 64 month)
Results posted on
2023-03-27
Participant Flow
This study contains an exploratory third arm evaluating the clinical benefit and the safety of the combination therapy of elotuzumab, nivolumab, pomalidomide and dexamethasone (Arm C: NE-Pd). Participants randomized to the Pd arm were allowed to cross over to this exploratory NE-Pd arm at the time of progression.
Participant milestones
| Measure |
Arm A: N-Pd
Nivolumab:
* Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle.
* Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle.
Pomalidomide:
\- 4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
* Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle
* Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
|
Arm B: Pd
Pomalidomide:
\- 4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
* Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle
* Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
|
Arm C: NE-Pd
Nivolumab:
* Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle.
* Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle.
Elotuzumab:
* Cycles 1 - 2: 10 mg/kg IV Days 1, 8, 15, and 22 of each 28-day cycle.
* Cycle 3 and 4: 10mg/kg IV Day 1 and 15 of each 28-day cycle.
* Cycles 5 and beyond: 20 mg/kg IV Day 1 of each 28-day cycle.
Pomalidomide:
4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
Days 1, 8, 15, and 22 of each cycle.
* Participants \</= 75 years old: weeks with elotuzumab dosing: 28 mg PO + 8 mg IV and 40 mg PO on non-elotuzumab dosing weeks.
* Participants \> 75 years old: weeks with elotuzumab dosing: 8 mg PO + 8 mg IV and 20 mg PO on non-elotuzumab dosing weeks.
|
|---|---|---|---|
|
Pre-Treatment Period
STARTED
|
75
|
71
|
24
|
|
Pre-Treatment Period
COMPLETED
|
72
|
70
|
24
|
|
Pre-Treatment Period
NOT COMPLETED
|
3
|
1
|
0
|
|
Treatment Period
STARTED
|
72
|
70
|
24
|
|
Treatment Period
NE-Pd Crossover
|
0
|
8
|
0
|
|
Treatment Period
COMPLETED
|
0
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
72
|
70
|
24
|
Reasons for withdrawal
| Measure |
Arm A: N-Pd
Nivolumab:
* Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle.
* Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle.
Pomalidomide:
\- 4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
* Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle
* Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
|
Arm B: Pd
Pomalidomide:
\- 4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
* Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle
* Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
|
Arm C: NE-Pd
Nivolumab:
* Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle.
* Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle.
Elotuzumab:
* Cycles 1 - 2: 10 mg/kg IV Days 1, 8, 15, and 22 of each 28-day cycle.
* Cycle 3 and 4: 10mg/kg IV Day 1 and 15 of each 28-day cycle.
* Cycles 5 and beyond: 20 mg/kg IV Day 1 of each 28-day cycle.
Pomalidomide:
4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
Days 1, 8, 15, and 22 of each cycle.
* Participants \</= 75 years old: weeks with elotuzumab dosing: 28 mg PO + 8 mg IV and 40 mg PO on non-elotuzumab dosing weeks.
* Participants \> 75 years old: weeks with elotuzumab dosing: 8 mg PO + 8 mg IV and 20 mg PO on non-elotuzumab dosing weeks.
|
|---|---|---|---|
|
Pre-Treatment Period
Participant request to discontinue study treatment
|
0
|
1
|
0
|
|
Pre-Treatment Period
Administrative reason by sponsor
|
2
|
0
|
0
|
|
Pre-Treatment Period
Participant no longer meets study criteria
|
1
|
0
|
0
|
|
Treatment Period
Disease progression
|
47
|
50
|
16
|
|
Treatment Period
Other reasons
|
9
|
8
|
2
|
|
Treatment Period
Study drug toxicity
|
6
|
3
|
2
|
|
Treatment Period
Adverse event unrelated to study drug
|
4
|
4
|
2
|
|
Treatment Period
Participant withdrew consent
|
3
|
1
|
1
|
|
Treatment Period
Participant request to discontinue study treatment
|
1
|
1
|
1
|
|
Treatment Period
Maximum clinical benefit
|
0
|
2
|
0
|
|
Treatment Period
Death
|
1
|
0
|
0
|
|
Treatment Period
Poor/non-compliance
|
1
|
0
|
0
|
|
Treatment Period
Participant no longer meets study criteria
|
0
|
1
|
0
|
Baseline Characteristics
An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Arm A: N-Pd
n=75 Participants
Nivolumab:
* Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle.
* Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle.
Pomalidomide:
\- 4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
* Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle
* Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
|
Arm B: Pd
n=71 Participants
Pomalidomide:
\- 4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
* Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle
* Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
|
Arm C: NE-Pd
n=24 Participants
Nivolumab:
* Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle.
* Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle.
Elotuzumab:
* Cycles 1 - 2: 10 mg/kg IV Days 1, 8, 15, and 22 of each 28-day cycle.
* Cycle 3 and 4: 10mg/kg IV Day 1 and 15 of each 28-day cycle.
* Cycles 5 and beyond: 20 mg/kg IV Day 1 of each 28-day cycle.
Pomalidomide:
4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
Days 1, 8, 15, and 22 of each cycle.
* Participants \</= 75 years old: weeks with elotuzumab dosing: 28 mg PO + 8 mg IV and 40 mg PO on non-elotuzumab dosing weeks.
* Participants \> 75 years old: weeks with elotuzumab dosing: 8 mg PO + 8 mg IV and 20 mg PO on non-elotuzumab dosing weeks.
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.9 Years
STANDARD_DEVIATION 9.4 • n=99 Participants
|
65.5 Years
STANDARD_DEVIATION 8.7 • n=107 Participants
|
66.2 Years
STANDARD_DEVIATION 11.5 • n=206 Participants
|
65.8 Years
STANDARD_DEVIATION 9.4 • n=157 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
57 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
113 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
96 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
34 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
68 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
13 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
155 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
PRIMARY outcome
Timeframe: From randomization to the date of the first documented tumor progression or death due to any cause, whichever occurred first (Up to approximately 64 month)Population: All randomized participants in Arm A and B. Data was pre-specified to be collected only in the N-Pd and Pd arms.
Randomization to first documented tumor progression or death due to any cause, whichever occurred first. Participants who die without reported prior progression are considered to have progressed on date of their death. Participants who did not progress or die will be censored at their last efficacy assessment. Participants who did not have on study efficacy assessments and alive will be censored on randomization date. Participants who started subsequent anti-cancer therapy without prior reported progression will be censored at last efficacy assessment prior to subsequent anti-cancer therapy. Progression is 1) increase of 25% from lowest confirmed response value in specific Serum M-protein and Urine M-protein criteria and increase of FLC for patients with no measurable M protein in blood or urine at baseline and/or 2) appearance of a new lesion(s), \>/= 50% increase from nadir in SPD of \> 1 lesion, or \>/= 50% increase in the longest diameter of a previous lesion \> 1 cm in short axis.
Outcome measures
| Measure |
Arm A: N-Pd
n=75 Participants
Nivolumab:
* Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle.
* Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle.
Pomalidomide:
\- 4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
* Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle
* Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
|
Arm B: Pd
n=71 Participants
Pomalidomide:
\- 4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
* Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle
* Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
8.38 Months
Interval 5.78 to 12.06
|
7.33 Months
Interval 6.47 to 8.44
|
SECONDARY outcome
Timeframe: From randomization to the date of death due to any cause (up to approximately 64 months)Population: All randomized participants in Arm A and B. Data was pre-specified to be collected only in the N-Pd and Pd arms.
The time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive.
Outcome measures
| Measure |
Arm A: N-Pd
n=75 Participants
Nivolumab:
* Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle.
* Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle.
Pomalidomide:
\- 4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
* Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle
* Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
|
Arm B: Pd
n=71 Participants
Pomalidomide:
\- 4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
* Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle
* Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
|
|---|---|---|
|
Overall Survival (OS)
|
24.87 Months
Interval 15.61 to 34.4
|
21.39 Months
Interval 17.91 to 27.56
|
SECONDARY outcome
Timeframe: From randomization up to approximately 64 monthsPopulation: All randomized participants in Arm A and B. Data was pre-specified to be collected only in the N-Pd and Pd arms.
The percentage of randomized participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) using International Myeloma Working Group (IMWG) criteria. sCR= Complete response as defined below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. CR = Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow aspirates. VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>/= 90% reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 h. PR = \>/= 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by \>/= 90% or to \< 200 mg per 24 h.
Outcome measures
| Measure |
Arm A: N-Pd
n=75 Participants
Nivolumab:
* Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle.
* Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle.
Pomalidomide:
\- 4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
* Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle
* Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
|
Arm B: Pd
n=71 Participants
Pomalidomide:
\- 4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
* Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle
* Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
48.0 Percentage of participants
Interval 36.3 to 59.8
|
54.9 Percentage of participants
Interval 42.7 to 66.8
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of the first sCR, CR, VGPR, or PR (up to approximately 64 months)Population: All responders (sCR, CR, VGPR, or PR) in Arm A and B. Data was pre-specified to be collected only in the N-Pd and Pd arms.
The time from the date of randomization to the date of the first stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). sCR= Complete response as defined below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. CR = Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow aspirates. VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>/= 90% reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 h. PR = \>/= 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by \>/= 90% or to \< 200 mg per 24 h.
Outcome measures
| Measure |
Arm A: N-Pd
n=36 Participants
Nivolumab:
* Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle.
* Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle.
Pomalidomide:
\- 4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
* Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle
* Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
|
Arm B: Pd
n=39 Participants
Pomalidomide:
\- 4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
* Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle
* Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
|
|---|---|---|
|
Time to Objective Response (TTR)
|
5.91 Months
Standard Deviation 9.09
|
4.37 Months
Standard Deviation 5.63
|
SECONDARY outcome
Timeframe: From randomization to the date of the first objectively documented tumor progression or death due to any cause prior to subsequent anti-cancer therapy (up to approximately 64 months)Population: All responders (sCR, CR, VGPR, or PR) in Arm A and B. Data was pre-specified to be collected only in the N-Pd and Pd arms.
The time between the date of first response to the date of the first objectively documented tumor progression as assessed by the investigator according to International Myeloma Working Group (IMWG) criteria or death due to any cause prior to subsequent anti-cancer therapy. Participants who neither progress nor die will be censored on the date of their last tumor assessment prior to subsequent anti-cancer therapy. Progression is 1) increase of 25% from lowest confirmed response value in specific Serum M-protein and Urine M-protein criteria and increase of FLC for patients with no measurable M protein in blood or urine at baseline and/or 2) appearance of a new lesion(s), \>/= 50% increase from nadir in SPD of \> 1 lesion, or \>/= 50% increase in the longest diameter of a previous lesion \> 1 cm in short axis.
Outcome measures
| Measure |
Arm A: N-Pd
n=36 Participants
Nivolumab:
* Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle.
* Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle.
Pomalidomide:
\- 4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
* Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle
* Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
|
Arm B: Pd
n=39 Participants
Pomalidomide:
\- 4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
* Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle
* Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
|
|---|---|---|
|
Duration of Objective Response (DOR)
|
8.51 Months
Interval 6.47 to 13.83
|
6.47 Months
Interval 5.55 to 11.07
|
Adverse Events
Arm A: N-Pd
Serious events: 52 serious events
Other events: 70 other events
Deaths: 47 deaths
Arm B: Pd
Serious events: 41 serious events
Other events: 65 other events
Deaths: 49 deaths
Arm C: NE-Pd
Serious events: 18 serious events
Other events: 24 other events
Deaths: 17 deaths
Arm B: NE-Pd Crossover
Serious events: 5 serious events
Other events: 7 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Arm A: N-Pd
n=72 participants at risk
Nivolumab:
* Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle.
* Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle.
Pomalidomide:
\- 4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
* Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle
* Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
|
Arm B: Pd
n=70 participants at risk
Pomalidomide:
\- 4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
* Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle
* Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
|
Arm C: NE-Pd
n=24 participants at risk
Nivolumab:
* Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle.
* Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle.
Elotuzumab:
* Cycles 1 - 2: 10 mg/kg IV Days 1, 8, 15, and 22 of each 28-day cycle.
* Cycle 3 and 4: 10mg/kg IV Day 1 and 15 of each 28-day cycle.
* Cycles 5 and beyond: 20 mg/kg IV Day 1 of each 28-day cycle.
Pomalidomide:
4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
Days 1, 8, 15, and 22 of each cycle.
* Participants \</= 75 years old: weeks with elotuzumab dosing: 28 mg PO + 8 mg IV and 40 mg PO on non-elotuzumab dosing weeks.
* Participants \> 75 years old: weeks with elotuzumab dosing: 8 mg PO + 8 mg IV and 20 mg PO on non-elotuzumab dosing weeks.
|
Arm B: NE-Pd Crossover
n=8 participants at risk
Participants who progressed on the Pd control arm and were allowed to crossover to the NE-Pd exploratory arm.
|
|---|---|---|---|---|
|
Infections and infestations
Septic shock
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.9%
2/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Anaemia
|
4.2%
3/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.8%
2/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.3%
3/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.8%
2/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.9%
2/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 first degree
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.9%
2/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 acute
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Amaurosis fugax
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Colitis
|
4.2%
3/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Incarcerated inguinal hernia
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Condition aggravated
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Impaired healing
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Localised oedema
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.9%
5/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
4/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Sudden death
|
2.8%
2/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Arthritis bacterial
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bacteraemia
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 infection
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.2%
3/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
3/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cytomegalovirus viraemia
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Encephalitis
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hand-foot-and-mouth disease
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 simplex
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Parainfluenzae virus infection
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 infection
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
12.5%
9/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
24.3%
17/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
6/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 cytomegaloviral
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 fungal
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.2%
3/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.3%
3/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.1%
8/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.3%
3/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
3/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.8%
2/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Vascular device infection
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Wound infection
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.9%
2/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lower limb fracture
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 complication
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Skin laceration
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 glucose increased
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
C-reactive protein increased
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Platelet count decreased
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Electrolyte imbalance
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Fluid retention
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.9%
2/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypoglycaemia
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Osteonecrosis of jaw
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Abdominal neoplasm
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 myeloid leukaemia
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Lung cancer metastatic
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Malignant melanoma
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Malignant neoplasm progression
|
12.5%
9/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.6%
6/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
4/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 myeloma
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.9%
2/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Rectal neoplasm
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Refractory cytopenia with unilineage dysplasia
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 thrombosis
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dysarthria
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Facial nerve disorder
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haemorrhage intracranial
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lacunar stroke
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.8%
2/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.9%
2/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.9%
2/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.9%
5/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.3%
3/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
4/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hydronephrosis
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 failure
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 impairment
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Atelectasis
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.3%
3/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Epistaxis
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.8%
2/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.8%
2/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.9%
2/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.9%
2/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Embolism
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haematoma
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypovolaemic shock
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 |
Arm A: N-Pd
n=72 participants at risk
Nivolumab:
* Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle.
* Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle.
Pomalidomide:
\- 4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
* Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle
* Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
|
Arm B: Pd
n=70 participants at risk
Pomalidomide:
\- 4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
* Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle
* Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
|
Arm C: NE-Pd
n=24 participants at risk
Nivolumab:
* Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle.
* Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle.
Elotuzumab:
* Cycles 1 - 2: 10 mg/kg IV Days 1, 8, 15, and 22 of each 28-day cycle.
* Cycle 3 and 4: 10mg/kg IV Day 1 and 15 of each 28-day cycle.
* Cycles 5 and beyond: 20 mg/kg IV Day 1 of each 28-day cycle.
Pomalidomide:
4 mg PO QD Days 1-21 of each 28-day cycle.
Dexamethasone:
Days 1, 8, 15, and 22 of each cycle.
* Participants \</= 75 years old: weeks with elotuzumab dosing: 28 mg PO + 8 mg IV and 40 mg PO on non-elotuzumab dosing weeks.
* Participants \> 75 years old: weeks with elotuzumab dosing: 8 mg PO + 8 mg IV and 20 mg PO on non-elotuzumab dosing weeks.
|
Arm B: NE-Pd Crossover
n=8 participants at risk
Participants who progressed on the Pd control arm and were allowed to crossover to the NE-Pd exploratory arm.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
36.1%
26/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
28.6%
20/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
45.8%
11/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.6%
4/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.9%
2/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
33.3%
24/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
31.4%
22/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
41.7%
10/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pancytopenia
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
22.2%
16/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.7%
11/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
4/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.8%
2/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypothyroidism
|
5.6%
4/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.6%
4/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
4/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
13.9%
10/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.9%
2/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Vitreous detachment
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.8%
2/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.1%
5/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.2%
3/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.1%
5/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.9%
5/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
23.6%
17/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
21.4%
15/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
4/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
30.6%
22/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
24.3%
17/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
20.8%
5/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.2%
3/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.1%
5/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.9%
5/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dysphagia
|
2.8%
2/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
19.4%
14/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.7%
11/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
4/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.9%
5/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.6%
6/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.8%
15/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
17.1%
12/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
4/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Chest pain
|
4.2%
3/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
4/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Chills
|
2.8%
2/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
4/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
47.2%
34/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
34.3%
24/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
41.7%
10/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
75.0%
6/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.9%
5/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
4/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
19.4%
14/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
21.4%
15/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
29.2%
7/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.6%
6/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
13.9%
10/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.9%
9/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
58.3%
14/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.1%
8/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.1%
5/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Candida infection
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.2%
3/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.3%
3/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Nasopharyngitis
|
6.9%
5/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
17.1%
12/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Oral infection
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Oropharyngeal candidiasis
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
13.9%
10/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
17.1%
12/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
20.8%
5/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
12.5%
9/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.6%
6/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.9%
2/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
4/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
19.4%
14/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
31.4%
22/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
3/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.7%
7/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.1%
5/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.2%
3/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.3%
3/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
4/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.8%
2/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.9%
2/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.9%
2/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.1%
8/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
4/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
3/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lymphocyte count decreased
|
9.7%
7/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.6%
6/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.7%
7/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.6%
6/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
3/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Platelet count decreased
|
6.9%
5/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
7/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
4/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.6%
4/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
3/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
White blood cell count decreased
|
8.3%
6/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
7/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
16.7%
12/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.3%
10/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.6%
4/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.7%
7/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.3%
3/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.2%
3/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.3%
10/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
4/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hyperkalaemia
|
2.8%
2/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.3%
3/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hyperuricaemia
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.3%
3/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.9%
5/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.3%
3/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
3/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.9%
5/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.6%
6/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
4/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
12.5%
9/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
7/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
20.8%
5/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.2%
3/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.9%
2/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
3/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.6%
4/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
4/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Vitamin B1 deficiency
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
15.3%
11/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.4%
8/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
16.7%
12/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
21.4%
15/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
4/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.7%
7/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.6%
6/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.3%
6/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.7%
11/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
3/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.3%
6/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
4/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
20.8%
5/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.3%
6/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
4/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.6%
4/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
4/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Neck pain
|
4.2%
3/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.7%
7/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.3%
3/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Resorption bone increased
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.1%
8/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.3%
10/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
29.2%
7/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.7%
7/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
7/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
3/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.2%
3/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.9%
2/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Neuropathy peripheral
|
2.8%
2/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.6%
6/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.2%
3/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
4/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.9%
5/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.1%
8/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.6%
6/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.8%
2/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
4/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.9%
5/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.6%
6/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hallucination
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
15.3%
11/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.7%
11/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
4/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 incontinence
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Atelectasis
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
15.3%
11/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
17.1%
12/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
6/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dysphonia
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
4/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
18.1%
13/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
21.4%
15/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
6/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
2/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Epistaxis
|
5.6%
4/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.3%
3/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
3/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.2%
3/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Nasal congestion
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
4/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.6%
4/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.9%
2/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.2%
1/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Wheezing
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
4/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Alopecia
|
1.4%
1/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Erythema
|
5.6%
4/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pruritus
|
12.5%
9/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
4/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
15.3%
11/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.4%
8/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
3/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Aortic stenosis
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Embolism
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haematoma
|
0.00%
0/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.6%
4/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.9%
9/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.3%
2/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk 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%
0/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.2%
3/72 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
1/70 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
3/24 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.5%
1/8 • AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER