Trial Outcomes & Findings for ACY-1215 (Ricolinostat) in Combination With Pomalidomide and Low-dose Dex in Relapsed-and-Refractory Multiple Myeloma (NCT NCT01997840)
NCT ID: NCT01997840
Last Updated: 2025-03-04
Results Overview
The maximum tolerated dose (MTD) was defined as the highest dose level at which no more than 1 of 6 patients experienced a dose-limiting toxicity (DLT) within the first 28-day cycle. If no more than 1 of these 6 patients experienced a DLT within the first 28-day cycle, then the last dose level enrolled to meet these criteria was identified as the recommended dose for the Phase 2 segment of the study.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
103 participants
Primary outcome timeframe
From first dose until the end of Phase 1b (up to a maximum of approximately 50 weeks).
Results posted on
2025-03-04
Participant Flow
The study consisted of Phase 1b (dose finding segment) part and Phase 2(dose expansion segment) part.
Participant milestones
| Measure |
Phase 1b - ACY-1215 Dose Level 1
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 1b - ACY-1215 Dose Level 3
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 1
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
85
|
11
|
|
Overall Study
Efficacy Evaluable Population
|
3
|
4
|
77
|
7
|
|
Overall Study
Safety Population
|
3
|
4
|
85
|
11
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
85
|
11
|
Reasons for withdrawal
| Measure |
Phase 1b - ACY-1215 Dose Level 1
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 1b - ACY-1215 Dose Level 3
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 1
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by participant
|
0
|
0
|
8
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
3
|
0
|
|
Overall Study
Progressive disease
|
3
|
4
|
57
|
8
|
|
Overall Study
Other reasons
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
15
|
2
|
Baseline Characteristics
ACY-1215 (Ricolinostat) in Combination With Pomalidomide and Low-dose Dex in Relapsed-and-Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Phase 1b - ACY-1215 Dose Level 1
n=3 Participants
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 1b - ACY-1215 Dose Level 3
n=4 Participants
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 1
n=85 Participants
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
n=11 Participants
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
89 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From first dose until the end of Phase 1b (up to a maximum of approximately 50 weeks).Population: All treated participants in Phase 1b. Prespecified to be reported as combined for Phase 1b only.
The maximum tolerated dose (MTD) was defined as the highest dose level at which no more than 1 of 6 patients experienced a dose-limiting toxicity (DLT) within the first 28-day cycle. If no more than 1 of these 6 patients experienced a DLT within the first 28-day cycle, then the last dose level enrolled to meet these criteria was identified as the recommended dose for the Phase 2 segment of the study.
Outcome measures
| Measure |
Phase 1b - ACY-1215
n=7 Participants
Participants received either 160 mg ACY-1215 once per day (Dose Level 1) or 160 mg ACY-1215 twice per day (Dose Level 3) and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 1
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of ACY-1215- Phase 1b
|
320 mg/day
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose until disease progression, study drug toxicity, end of study, or death due to any cause (up to approximately 120 months).Population: All treated participants in Phase 2 Efficacy evaluable population. Prespecified to be reported for Phase 2 only.
Overall response rate (ORR) is defined as the percentage of participants with a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). sCR: * No detectable myeloma cells in the bone marrow. * Normal free light chain ratio. * Absence of clonal cells in the bone marrow. CR: * Negative immunofixation on the serum and urine. * Disappearance of any soft tissue plasmacytomas. * Less than 5% plasma cells in the bone marrow. VGPR: * Serum and urine M-protein detectable by immunofixation but not on electrophoresis, or * At least a 90% reduction in serum M-protein plus urine M-protein level less than 100 mg per 24 hours. PR: * At least a 50% reduction in serum M-protein. * Reduction in 24-hour urinary M-protein by at least 90% or to less than 200 mg per 24 hours. * For patients with non-secretory myeloma, a reduction of at least 50% in the size of soft tissue plasmacytomas is required.
Outcome measures
| Measure |
Phase 1b - ACY-1215
n=77 Participants
Participants received either 160 mg ACY-1215 once per day (Dose Level 1) or 160 mg ACY-1215 twice per day (Dose Level 3) and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
n=7 Participants
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 1
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR) Per Investigator - Phase 2
|
39.0 Percent of Participants
Interval 28.0 to 50.8
|
71.4 Percent of Participants
Interval 29.0 to 96.3
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose until disease progression, study drug toxicity, end of study, or death due to any cause (up to approximately 120 months).Population: All treated participants in the Efficacy Evaluable population with a best response of PR or CR.
Time to response (TTR) was defined as the time from first dose of study treatment to the first documentation of response (either partial response (PR) or complete response (CR)). CR: * Negative immunofixation on the serum and urine. * Disappearance of any soft tissue plasmacytomas. * Less than 5% plasma cells in the bone marrow. PR: * At least a 50% reduction in serum M-protein. * Reduction in 24-hour urinary M-protein by at least 90% or to less than 200 mg per 24 hours. * For patients with non-secretory myeloma, a reduction of at least 50% in the size of soft tissue plasmacytomas is required.
Outcome measures
| Measure |
Phase 1b - ACY-1215
n=2 Participants
Participants received either 160 mg ACY-1215 once per day (Dose Level 1) or 160 mg ACY-1215 twice per day (Dose Level 3) and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 1
n=30 Participants
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
n=5 Participants
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|---|---|---|
|
Time to Response (TTR)
|
8.50 Weeks
Interval 4.1 to 12.9
|
—
|
10.83 Weeks
Interval 4.1 to 40.1
|
12.96 Weeks
Interval 7.9 to 31.9
|
SECONDARY outcome
Timeframe: From first dose until disease progression, study drug toxicity, end of study, or death due to any cause (up to approximately 120 months).Population: All treated participants in the Efficacy Evaluable population with a best response of PR or CR.
Duration of Response (DOR) was defined as the time from first partial response (PR) or complete response (CR) to the first documentation of progressive disease (PD) or death. PR: * \>= 50% reduction in serum M-protein. * Reduction in 24-hour urinary M-protein by \>= 90% or to less than 200 mg per 24 hours. * For non-secretory myeloma, a reduction of \>= 50% in size of soft tissue plasmacytomas. CR: * Negative immunofixation on the serum and urine. * Disappearance of any soft tissue plasmacytomas. * \< 5% plasma cells in the bone marrow. PD: * Increase of 25% or more from nadir in serum M-protein, absolute increase of \>= 0.5 g/dL. * Increase of 25% or more from nadir in 24-hour urinary M-protein, absolute increase of \>=200 mg/24 hours. * Increase of 25% or more in the percentage of bone marrow plasma cells, absolute increase of \>=10%. Calculated using Kaplan-Meier estimates.
Outcome measures
| Measure |
Phase 1b - ACY-1215
n=2 Participants
Participants received either 160 mg ACY-1215 once per day (Dose Level 1) or 160 mg ACY-1215 twice per day (Dose Level 3) and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 1
n=30 Participants
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
n=5 Participants
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|---|---|---|
|
Duration of Response (DoR)
|
20.10 Weeks
Interval 4.1 to 36.1
|
—
|
30.30 Weeks
Interval 13.1 to 43.1
|
62.75 Weeks
Interval 54.75 to 121.6
|
SECONDARY outcome
Timeframe: From first dose until disease progression, study drug toxicity, end of study, or death due to any cause (up to approximately 120 months).Population: All treated participants in the Efficacy Evaluable population who had PD.
Time to progression (TTP) was defined as the time from the date of first dose to the date of first documentation of progressive disease (PD). PD: * Increase of 25% or more from nadir in serum M-protein, absolute increase of \>= 0.5 g/dL. * Increase of 25% or more from nadir in 24-hour urinary M-protein, absolute increase of \>=200 mg/24 hours. * Increase of 25% or more in the percentage of bone marrow plasma cells, absolute increase of \>=10%. * New bone lesions or soft tissue plasmacytomas or increase size of existing bone lesions or soft tissue plasmacytomas. * Hypercalcemia attributed to myeloma.
Outcome measures
| Measure |
Phase 1b - ACY-1215
n=3 Participants
Participants received either 160 mg ACY-1215 once per day (Dose Level 1) or 160 mg ACY-1215 twice per day (Dose Level 3) and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
n=4 Participants
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 1
n=77 Participants
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
n=7 Participants
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|---|---|---|
|
Time to Progression (TTP)
|
22.43 Weeks
Interval 8.1 to 48.9
|
6.20 Weeks
Interval 4.1 to 8.1
|
29.82 Weeks
Interval 3.9 to 169.1
|
83.22 Weeks
Interval 7.7 to 183.1
|
SECONDARY outcome
Timeframe: From first dose until disease progression, study drug toxicity, end of study, or death due to any cause (up to approximately 120 months).Population: All treated participants in the Efficacy Evaluable population.
Progression-free survival (PFS) was defined as the time from first dose of study treatment to the first documentation of progressive disease (PD) or death from any cause during study PD: * Increase of 25% or more from nadir in serum M-protein, absolute increase of \>= 0.5 g/dL. * Increase of 25% or more from nadir in 24-hour urinary M-protein, absolute increase of \>=200 mg/24 hours. * Increase of 25% or more in the percentage of bone marrow plasma cells, absolute increase of \>=10%. * New bone lesions or soft tissue plasmacytomas or increase size of existing bone lesions or soft tissue plasmacytomas. * Hypercalcemia attributed to myeloma. Calculated using Kaplan-Meier estimates.
Outcome measures
| Measure |
Phase 1b - ACY-1215
n=3 Participants
Participants received either 160 mg ACY-1215 once per day (Dose Level 1) or 160 mg ACY-1215 twice per day (Dose Level 3) and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
n=4 Participants
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 1
n=77 Participants
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
n=7 Participants
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
10.30 Weeks
Interval 8.1 to 48.9
|
6.30 Weeks
Interval 4.35 to 8.05
|
20.00 Weeks
Interval 9.1 to 41.6
|
62.70 Weeks
Interval 19.9 to 99.9
|
SECONDARY outcome
Timeframe: From first dose until disease progression, study drug toxicity, end of study, or death due to any cause (up to approximately 120 months).Population: All treated participants in the Efficacy Evaluable population. Data not collected.
Overall response rate (ORR) per Central Adjudication Committee is the percentage of participants with a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). sCR: * No detectable myeloma cells in the bone marrow. * Normal free light chain ratio. * Absence of clonal cells in the bone marrow. CR: * Negative immunofixation on the serum and urine. * Disappearance of any soft tissue plasmacytomas. * Less than 5% plasma cells in the bone marrow. VGPR: * Serum and urine M-protein detectable by immunofixation but not on electrophoresis, or * At least a 90% reduction in serum M-protein plus urine M-protein level less than 100 mg per 24 hours. PR: * At least a 50% reduction in serum M-protein. * Reduction in 24-hour urinary M-protein by at least 90% or to less than 200 mg per 24 hours. * For patients with non-secretory myeloma, a reduction of at least 50% in the size of soft tissue plasmacytomas is required
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks)Population: All treated participants in the Safety population.
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Outcome measures
| Measure |
Phase 1b - ACY-1215
n=3 Participants
Participants received either 160 mg ACY-1215 once per day (Dose Level 1) or 160 mg ACY-1215 twice per day (Dose Level 3) and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
n=4 Participants
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 1
n=85 Participants
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
n=11 Participants
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
3 Participants
|
4 Participants
|
82 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: From first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks)Population: All treated participants in the Safety population.
A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that: * Results in death; * Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE); * Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay). * Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions); * Is a congenital anomaly/birth defect; * Constitutes an important medical event. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Outcome measures
| Measure |
Phase 1b - ACY-1215
n=3 Participants
Participants received either 160 mg ACY-1215 once per day (Dose Level 1) or 160 mg ACY-1215 twice per day (Dose Level 3) and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
n=4 Participants
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 1
n=85 Participants
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
n=11 Participants
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
0 Participants
|
2 Participants
|
37 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks)Population: All treated participants in the Safety population.
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Outcome measures
| Measure |
Phase 1b - ACY-1215
n=3 Participants
Participants received either 160 mg ACY-1215 once per day (Dose Level 1) or 160 mg ACY-1215 twice per day (Dose Level 3) and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
n=4 Participants
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 1
n=85 Participants
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
n=11 Participants
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
ACY-1215
|
0 Participants
|
0 Participants
|
13 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
Pomalidomide
|
0 Participants
|
0 Participants
|
13 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
Dexamethasone
|
0 Participants
|
0 Participants
|
16 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks)Population: All treated participants in the Safety population.
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Outcome measures
| Measure |
Phase 1b - ACY-1215
n=3 Participants
Participants received either 160 mg ACY-1215 once per day (Dose Level 1) or 160 mg ACY-1215 twice per day (Dose Level 3) and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
n=4 Participants
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 1
n=85 Participants
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
n=11 Participants
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) Related to Study Drug
ACY-1215
|
1 Participants
|
4 Participants
|
63 Participants
|
9 Participants
|
|
Number of Participants With Adverse Events (AEs) Related to Study Drug
Pomalidomide
|
3 Participants
|
4 Participants
|
62 Participants
|
11 Participants
|
|
Number of Participants With Adverse Events (AEs) Related to Study Drug
Dexamethasone
|
2 Participants
|
3 Participants
|
57 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 day 1, Cycle 1 Day 2, Cycle 1 Day 8Population: All treated participants with available PK results. Prespecified to be reported for Phase 1b only. Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 day 1, Cycle 1 Day 2, Cycle 1 Day 8Population: All treated participants with available ADA results. Prespecified to be reported for Phase 1b only. Data not collected.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1b - ACY-1215 Dose Level 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1b - ACY-1215 Dose Level 3
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase 2 - ACY-1215 Dose Level 1
Serious events: 37 serious events
Other events: 82 other events
Deaths: 39 deaths
Phase 2 - ACY-1215 Dose Level 3
Serious events: 7 serious events
Other events: 11 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Phase 1b - ACY-1215 Dose Level 1
n=3 participants at risk
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 1b - ACY-1215 Dose Level 3
n=4 participants at risk
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 1
n=85 participants at risk
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
n=11 participants at risk
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
3/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
3/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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 chronic
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Drug hypersensitivity
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Corona virus infection
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Implant site infection
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.1%
6/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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 viral
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
3/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Hip fracture
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Lumbar vertebral fracture
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
3/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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)
Cholangiocarcinoma
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
3/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Embolic stroke
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Radiculopathy
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Haematuria
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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 acute
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Pneumonia aspiration
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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 distress
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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 aneurysm
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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 |
Phase 1b - ACY-1215 Dose Level 1
n=3 participants at risk
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 1b - ACY-1215 Dose Level 3
n=4 participants at risk
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 1
n=85 participants at risk
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
Phase 2 - ACY-1215 Dose Level 3
n=11 participants at risk
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
36.5%
31/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
3/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Lymphadenopathy
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
3/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
34.1%
29/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
45.5%
5/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
20.0%
17/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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 tachycardia
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Tricuspid valve disease
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Deafness
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Ear pain
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Tinnitus
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Diplopia
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Ectropion
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
3/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.2%
7/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.2%
7/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.1%
6/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
75.0%
3/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
16.5%
14/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
100.0%
4/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
37.6%
32/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
54.5%
6/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
4/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
3/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
3/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.4%
19/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
27.3%
3/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.6%
9/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.2%
7/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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 discomfort
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
4/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
4/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
57.6%
49/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
72.7%
8/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Feeling jittery
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
5/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Instillation site pain
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
4/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Local swelling
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
4/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
5/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.3%
13/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
21.2%
18/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
3/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
3/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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 virus infection
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
3/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Localised infection
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
3/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.4%
8/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
24.7%
21/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
27.3%
3/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.1%
6/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Compression fracture
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Periorbital contusion
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Procedural pain
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Scar
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.2%
7/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.1%
6/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
4/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood cholesterol increased
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.2%
7/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Gamma-glutamyltransferase increased
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Haemoglobin decreased
|
100.0%
3/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
27.3%
3/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.1%
12/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
27.3%
3/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.1%
6/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
36.4%
4/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
3/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
4/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
36.4%
4/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.6%
9/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
27.3%
3/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
4/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.2%
7/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Hypermagnesaemia
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
4/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
5/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.9%
11/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
3/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.2%
7/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
27.3%
3/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.2%
7/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Polydipsia
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.3%
13/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Arthropathy
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.3%
13/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
27.3%
3/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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 disorder
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.9%
11/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Bursitis
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Joint swelling
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
20.0%
17/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
27.3%
3/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.6%
9/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
4/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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 discomfort
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
4/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Osteoarthritis
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Osteoporosis
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.6%
9/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Rotator cuff syndrome
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Tenosynovitis
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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)
Skin papilloma
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Balance disorder
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.9%
11/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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 postural
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.9%
11/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.2%
7/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
3/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Memory impairment
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
4/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
4/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Somnolence
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.8%
10/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
VIth nerve paralysis
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
3/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.1%
6/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.8%
16/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
27.3%
3/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Mood altered
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
4/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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 acute
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Bronchospasm
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
17.6%
15/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
27.3%
3/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.4%
8/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
27.3%
3/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.6%
9/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.4%
8/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Hiccups
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
4/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Lung infiltration
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
4/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
27.3%
3/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.4%
8/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
5/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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 hypertension
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Rhinorrhoea
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
3/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Sinus congestion
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Throat irritation
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
4/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Actinic keratosis
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Dry skin
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Ecchymosis
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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 multiforme
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Hair growth abnormal
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Hair texture abnormal
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Hyperhidrosis
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
27.3%
3/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Night sweats
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
5/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.8%
10/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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 maculo-papular
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
Swelling face
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
1/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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 arteriosclerosis
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
5/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.4%
2/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
36.4%
4/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
3/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/85 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed from first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks).
All-Cause Mortality, 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