Trial Outcomes & Findings for Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma (NCT NCT02654990)
NCT ID: NCT02654990
Last Updated: 2024-07-12
Results Overview
ORR is defined as the percentage of participants with a confirmed partial response (PR) or better (immunophenotypic complete response \[iCR\] or stringent complete response \[sCR\] or complete response \[CR\] or very good partial response \[VGPR\]) as their best overall response after completion of up to 8 cycles of assigned study regimen. Each cycle was 21 days long. Best overall response was the best post-baseline confirmed overall response observed in a given participant and was determined based on overall responses observed at all post-baseline response assessments, recorded from randomization until progressive disease (PD), death, start of new therapy, withdrawal of consent, or end of study, whatever came first. ORR was assessed blindly per independent review committee (IRC) according to International Myeloma Working Group (IMWG) criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
248 participants
Primary outcome timeframe
Up to 168 days
Results posted on
2024-07-12
Participant Flow
Participant milestones
| Measure |
Arm A - Panobinostat (20 mg, TIW)
Participants received 20 milligrams (mg) panobinostat thrice a week (TIW), 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
Participants received 20 mg panobinostat twice a week (BIW), 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
Overall Study
STARTED
|
82
|
83
|
83
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
79
|
82
|
80
|
|
Overall Study
COMPLETED
|
82
|
83
|
83
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=82 Participants
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=83 Participants
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=83 Participants
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.0 years
n=5 Participants
|
65.0 years
n=7 Participants
|
66.0 years
n=5 Participants
|
66.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Southeast Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
17 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown/Not Reported
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
73 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
213 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
0
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
1
|
36 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
2
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 168 daysPopulation: Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.
ORR is defined as the percentage of participants with a confirmed partial response (PR) or better (immunophenotypic complete response \[iCR\] or stringent complete response \[sCR\] or complete response \[CR\] or very good partial response \[VGPR\]) as their best overall response after completion of up to 8 cycles of assigned study regimen. Each cycle was 21 days long. Best overall response was the best post-baseline confirmed overall response observed in a given participant and was determined based on overall responses observed at all post-baseline response assessments, recorded from randomization until progressive disease (PD), death, start of new therapy, withdrawal of consent, or end of study, whatever came first. ORR was assessed blindly per independent review committee (IRC) according to International Myeloma Working Group (IMWG) criteria.
Outcome measures
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=82 Participants
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=83 Participants
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=83 Participants
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
Overall Response Rate (ORR)
|
62.2 percentage of participants
Interval 50.8 to 72.7
|
65.1 percentage of participants
Interval 53.8 to 75.2
|
50.6 percentage of participants
Interval 39.4 to 61.8
|
SECONDARY outcome
Timeframe: Up to 5.2 yearsPopulation: Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.
ORR is defined as the percentage of participants with a confirmed PR or better (iCR or sCR or CR or VGPR) as their best overall response throughout the entire study. Best overall response was the best post-baseline confirmed overall response observed in a given participant and was determined based on overall responses observed at all post-baseline response assessments, recorded from randomization until PD, death, start of new therapy, withdrawal of consent or end of study, whatever came first. ORR was assessed blindly per IRC according to IMWG criteria.
Outcome measures
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=82 Participants
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=83 Participants
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=83 Participants
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
ORR Throughout the Study
|
62.2 percentage of participants
Interval 50.8 to 72.7
|
67.5 percentage of participants
Interval 56.3 to 77.4
|
53.0 percentage of participants
Interval 41.7 to 64.1
|
SECONDARY outcome
Timeframe: Up to 5.2 yearsPopulation: Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.
iCR, based on IMWG criteria per blinded IRC assessment, is defined as: negative immunofixation of serum and urine; disappearance of any soft tissue plasmacytoma(s), in the case of any presence of soft tissue plasmacytoma(s) at baseline; less than 5% plasma cells in bone marrow; normal free light chain (FLC) ratio; absence of clonal plasma cells in bone marrow analyzed by immunohistochemistry or 2- to 4-color flow cytometry; absence of phenotypically aberrant plasma cells (clonal) in bone marrow (BM) with a minimum of 1 million total BM cells analyzed by multiparametric flow cytometry (\>4 colors). Results reported as percentage of participants achieving iCR.
Outcome measures
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=82 Participants
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=83 Participants
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=83 Participants
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
iCR Rate
|
3.7 percentage of participants
|
1.2 percentage of participants
|
1.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5.2 yearsPopulation: Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.
sCR, based on IMWG criteria per blinded IRC assessment, is defined as: negative immunofixation of serum and urine; disappearance of any soft tissue plasmacytoma(s), in the case of any presence of soft tissue plasmacytoma(s) at baseline; less than 5% plasma cells in bone marrow; normal FLC ratio; absence of clonal plasma cells in bone marrow analyzed by immunohistochemistry or 2- to 4-color flow cytometry. Results reported as percentage of participants achieving sCR.
Outcome measures
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=82 Participants
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=83 Participants
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=83 Participants
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
sCR Rate
|
1.2 percentage of participants
|
1.2 percentage of participants
|
3.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5.2 yearsPopulation: Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.
CR, based on IMWG criteria per blinded IRC assessment, is defined as: negative immunofixation of serum and urine; disappearance of any soft tissue plasmacytoma(s), in the case of any presence of soft tissue plasmacytoma(s) at baseline; less than 5% plasma cells in bone marrow; in case the only measurable disease at baseline is the serum FLC assessment, a normal FLC ratio of 0.26 to 1.65 is required additionally to qualify for CR. Results reported as percentage of participants achieving CR.
Outcome measures
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=82 Participants
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=83 Participants
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=83 Participants
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
CR Rate
|
8.5 percentage of participants
|
8.4 percentage of participants
|
2.4 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5.2 yearsPopulation: Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.
VGPR, based on IMWG criteria per blinded IRC assessment, is defined as: serum and/or urine M protein detectable by immunofixation but not on protein electrophoresis, or ≥90% reduction from baseline in serum) and urine M protein \<100 milligrams/24 hours); in the case of the presence of any soft tissue plasmacytoma(s) at baseline, a reduction in the sum of the products of the cross-diameters by ≥50% from baseline is required; in case the only measurable disease in a participant at baseline is the serum FLC level (that is, no measurable disease in serum and urine PEP), a decrease of \>90% in the difference between involved and uninvolved FLC levels from baseline is required. Results reported as percentage of participants achieving VGPR.
Outcome measures
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=82 Participants
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=83 Participants
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=83 Participants
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
VGPR Rate
|
19.5 percentage of participants
|
25.3 percentage of participants
|
20.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5.2 yearsPopulation: Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.
PFS, assessed based on IMWG criteria per blind IRC assessment, is defined as the time from date of randomization to date of first documented disease progression or death (regardless of cause of death).
Outcome measures
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=82 Participants
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=83 Participants
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=83 Participants
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
15 months
Interval 7.4 to 24.7
|
13 months
Interval 7.0 to 13.8
|
8 months
Interval 5.0 to 10.7
|
SECONDARY outcome
Timeframe: Up to 5.2 yearsPopulation: Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.
OS is defined as the time from date of randomization to the date of death due to any cause.
Outcome measures
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=82 Participants
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=83 Participants
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=83 Participants
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
Overall Survival (OS)
|
35 months
Interval 27.8 to
Not evaluable due to insufficient number of events
|
32 months
Interval 30.7 to
Not evaluable due to insufficient number of events
|
22 months
Interval 18.6 to
Not evaluable due to insufficient number of events
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose)Population: Pharmacokinetics Analysis Set (PAS): all participants with at least 1 evaluable pharmacokinetics concentration of panobinostat after dosing on Day 1. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed.
Serial blood samples were collected for panobinostat Cmax analysis. Results are reported in nanograms/milliliter (ng/mL).
Outcome measures
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=50 Participants
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=64 Participants
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=62 Participants
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax): Panobinostat
|
14.30 ng/mL
Standard Deviation 7.77
|
14.12 ng/mL
Standard Deviation 8.96
|
6.13 ng/mL
Standard Deviation 3.51
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose)Population: Pharmacokinetics Analysis Set (PAS): all participants with at least 1 evaluable pharmacokinetics concentration of bortezomib after dosing on Day 1. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed.
Serial blood samples were collected for bortezomib Cmax analysis. Results are reported in ng/mL.
Outcome measures
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=61 Participants
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=69 Participants
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=63 Participants
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
Cmax: Bortezomib
|
16.67 ng/mL
Standard Deviation 7.79
|
19.47 ng/mL
Standard Deviation 10.00
|
18.29 ng/mL
Standard Deviation 8.80
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose)Population: Pharmacokinetics Analysis Set (PAS): all participants with at least 1 evaluable pharmacokinetics concentration of panobinostat after dosing on Day 1. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed.
Serial blood samples were collected for panobinostat Tmax analysis. Results are reported in hours.
Outcome measures
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=50 Participants
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=64 Participants
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=62 Participants
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
Time to Reach Cmax (Tmax): Panobinostat
|
1.93 hours
Standard Deviation 1.53
|
1.80 hours
Standard Deviation 1.63
|
1.82 hours
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose)Population: Pharmacokinetics Analysis Set (PAS): all participants with at least 1 evaluable pharmacokinetics concentration of bortezomib after dosing on Day 1. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed.
Serial blood samples were collected for bortezomib Tmax analysis. Results are reported in hours.
Outcome measures
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=61 Participants
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=69 Participants
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=63 Participants
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
Tmax: Bortezomib
|
0.84 hours
Standard Deviation 0.46
|
0.77 hours
Standard Deviation 0.36
|
0.77 hours
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: Up to 5.2 YearsPopulation: Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed.
The exposure-response relationship was assessed utilizing Cmax (Cycle 1 Day 1) for panobinostat versus the outcomes of ORR, grade 3/4 thrombocytopenia, and grade 3/4 diarrhea. Two statistical models were used: logistic regression models, in which these 3 outcomes were treated in a binary fashion according to their occurrence; Cox regression models, with the relevant outcomes being the time to occurrence of grade 3/4 thrombocytopenia and the time to occurrence of grade 3/4 diarrhea. Results are reported as model-based probability. An increase in the model-based probability indicates an increase in the occurrence of the outcomes (ORR, grade 3/4 thrombocytopenia, 3/4 diarrhea) with increasing values of Cmax (that is, with increasing dose of panobinostat).
Outcome measures
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=18 Participants
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=20 Participants
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=18 Participants
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
Exposure Response: Cmax for Panobinostat
ORR by IRC (up to 8 cycles)
|
63.1 percent probability
Interval 46.7 to 76.9
|
62.2 percent probability
Interval 47.5 to 75.0
|
35.3 percent probability
Interval 20.6 to 53.4
|
|
Exposure Response: Cmax for Panobinostat
Grade 3/4 Thrombocytopenia
|
32.2 percent probability
Interval 17.7 to 51.2
|
28.7 percent probability
Interval 17.5 to 43.4
|
21.7 percent probability
Interval 10.6 to 39.4
|
|
Exposure Response: Cmax for Panobinostat
Grade 3/4 Diarrhea
|
6.2 percent probability
Interval 2.1 to 16.7
|
7.5 percent probability
Interval 3.1 to 17.2
|
2.5 percent probability
Interval 0.3 to 16.3
|
SECONDARY outcome
Timeframe: Cycle 15 Day 1, at approximately 295 daysPopulation: Full analysis set (FAS): all participants to whom study treatment was assigned by randomization and who had a valid baseline HRQoL assessment and at least 1 post-baseline assessment. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed.
Health-related quality of life (HRQoL) was assessed by the EORTC QLQ-C30, which is frequently employed in clinical oncology trials and is recognized as reliable and valid. The EORTC QLQ-C30 measures functional dimensions (physical, role, emotional, cognitive, and social), 3 symptom items (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact), and a global health scale (GHS) and quality-of-life scale. For each domain and item, a linear transformation is applied to standardize the score between 0 and 100. Results are presented specifically for the GHS score. A higher GHS score indicates a higher HRQoL. Each cycle was 21 days long.
Outcome measures
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=18 Participants
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=16 Participants
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=18 Participants
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
Change From Baseline in European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Core 30-item Questionnaire (QLQ-C30) Global Health Status (GHS) Score
|
6.0 score on a scale
Standard Deviation 23.01
|
0.0 score on a scale
Standard Deviation 30.12
|
-4.6 score on a scale
Standard Deviation 24.12
|
SECONDARY outcome
Timeframe: Cycle 15 Day 1, at approximately 295 daysPopulation: Full analysis set (FAS): all participants to whom study treatment was assigned by randomization and who had a valid baseline HRQoL assessment and at least 1 post-baseline assessment. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed.
HRQoL was assessed by the FACT/GOG-Ntx, a 38-item questionnaire designed to assess general quality of life and severity and impact of neurotoxicity from systemic chemotherapy. It is frequently employed in clinical oncology trials and is recognized as a reliable and valid measure to assess symptoms associated with neurotoxicity. It focuses on 4 general quality of life domains for physical well-being, functional well-being, social/family well-being, and emotional well-being, and includes the neurotoxicity subscale domain to characterize treatment-related neurotoxicity. Results are presented specifically for the 11-item neurotoxicity subscale, which uses a 5-point rating scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). Each item is scored from 0-4, with the severity of neurotoxicity measured as the sum of the 11 items, ranging from 0 to 44. Lower scores indicate lower neurotoxicity and higher HRQoL. Each cycle was 21 days long.
Outcome measures
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=18 Participants
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=15 Participants
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=18 Participants
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
Change From Baseline in the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group-Neurotoxicity (GOG-Ntx) Neurotoxicity Subscale Score
|
-3.6 score on a scale
Standard Deviation 7.39
|
-3.9 score on a scale
Standard Deviation 4.19
|
-0.1 score on a scale
Standard Deviation 5.71
|
SECONDARY outcome
Timeframe: Up to 5.2 yearsPopulation: Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.
TTP, based on IMWG criteria per blinded IRC assessment, is defined as the time from the date of randomization to the date of the first documented disease progression or death due to multiple myeloma.
Outcome measures
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=82 Participants
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=83 Participants
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=83 Participants
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
Time to Progression (TTP)
|
17 months
Interval 8.3 to
Not evaluable due to insufficient number of events
|
13 months
Interval 7.0 to 16.1
|
8 months
Interval 5.9 to 11.6
|
SECONDARY outcome
Timeframe: Up to 5.2 yearsPopulation: Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.
TTR, based on IMWG criteria per blinded IRC assessment, is the time between date of randomization to the date of first onset of PR or better response (iCR or sCR or CR or VGPR).
Outcome measures
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=82 Participants
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=83 Participants
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=83 Participants
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
Time to Response (TTR)
|
3 months
Interval 1.0 to
Not evaluable due to insufficient number of events
|
3 months
Interval 1.0 to
Not evaluable due to insufficient number of events
|
3 months
Interval 1.0 to
Not evaluable due to insufficient number of events
|
SECONDARY outcome
Timeframe: Up to 5.2 yearsPopulation: Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.
DOR, based on IMWG criteria per blinded IRC assessment, is defined as the duration from the first documented onset of PR or better (iCR or sCR or CR or VGPR) to the date of first documented disease progression or death due to multiple myeloma.
Outcome measures
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=82 Participants
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=83 Participants
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=83 Participants
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
Duration of Response (DOR)
|
22 months
Interval 13.9 to
Not evaluable due to insufficient number of events
|
12 months
Interval 8.8 to 21.3
|
10.429 months
Interval 6.2 to 14.5
|
Adverse Events
Arm A - Panobinostat (20 mg, TIW)
Serious events: 44 serious events
Other events: 78 other events
Deaths: 34 deaths
Arm B - Panobinostat (20 mg, BIW)
Serious events: 40 serious events
Other events: 82 other events
Deaths: 41 deaths
Arm C - Panobinostat (10 mg, TIW)
Serious events: 36 serious events
Other events: 78 other events
Deaths: 47 deaths
Serious adverse events
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=78 participants at risk
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=83 participants at risk
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=80 participants at risk
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.8%
3/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.4%
2/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
2/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.4%
2/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Blood and lymphatic system disorders
Bicytopenia
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Blood and lymphatic system disorders
Methaemoglobinaemia
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Cardiac disorders
Atrial Flutter
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Cardiac disorders
Cardiac Failure
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.5%
2/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
3/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.4%
2/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
3.6%
3/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.4%
2/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal Motility Disorder
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
General disorders
Asthenia
|
2.6%
2/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
General disorders
Fatigue
|
2.6%
2/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.4%
2/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
General disorders
Drug Withdrawal Syndrome
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
General disorders
Death
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
3.6%
3/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
General disorders
Pain
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
4.8%
4/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Pneumonia
|
10.3%
8/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
13.3%
11/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
11.2%
9/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
3.8%
3/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Bacterial Pyelonephritis
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Bronchitis
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.4%
2/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Gastroenteritis
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Infection
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Meningitis
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Pneumonia Parainfluenza Viral
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Pyelonephritis
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Sepsis
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
4.8%
4/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Abscess Limb
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Bacterial Sepsis
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Diarrhoea Infectious
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Haemophilus Sepsis
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.4%
2/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Parainfluenza Virus Infection
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Pneumonia Haemophilus
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Pneumonia Viral
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Pyelonephritis Acute
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Rhinovirus Infection
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.4%
2/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Streptococcal Sepsis
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.5%
2/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Injury, poisoning and procedural complications
Forearm Fracture
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Injury, poisoning and procedural complications
Transfusion-related Acute Lung Injury
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Investigations
Troponin Increased
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Investigations
Blood Creatine Increased
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Investigations
Myocardial Necrosis Marker Increased
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
3.8%
3/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.5%
2/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Tract Adenoma
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haematological Malignancy
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Nervous system disorders
Syncope
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Psychiatric disorders
Hypomania
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.5%
2/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/39 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.3%
1/44 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/48 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Reproductive system and breast disorders
Orchitis Noninfective
|
0.00%
0/39 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.3%
1/44 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/48 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
3/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive Airways Disorder
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Vascular disorders
Circulatory Collapse
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Vascular disorders
Hypotension
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Vascular disorders
Peripheral Ischaemia
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.5%
2/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Respiratory Tract Infection
|
3.8%
3/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
Other adverse events
| Measure |
Arm A - Panobinostat (20 mg, TIW)
n=78 participants at risk
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm B - Panobinostat (20 mg, BIW)
n=83 participants at risk
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
Arm C - Panobinostat (10 mg, TIW)
n=80 participants at risk
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
55.1%
43/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
44.6%
37/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
32.5%
26/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
42.3%
33/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
26.5%
22/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
30.0%
24/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
32.1%
25/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
19.3%
16/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
12.5%
10/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.4%
5/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.5%
2/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Eye disorders
Cataract
|
7.7%
6/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
3.6%
3/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
65.4%
51/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
63.9%
53/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
48.8%
39/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Nausea
|
37.2%
29/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
34.9%
29/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
16.2%
13/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Constipation
|
26.9%
21/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
19.3%
16/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
22.5%
18/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
20.5%
16/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
25.3%
21/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
7.5%
6/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
15.4%
12/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
10.8%
9/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.5%
9/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
3.6%
3/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
5.0%
4/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.4%
5/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
13.3%
11/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
8.8%
7/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
5.1%
4/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.4%
2/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
General disorders
Fatigue
|
34.6%
27/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
30.1%
25/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
30.0%
24/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
General disorders
Asthenia
|
32.1%
25/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
34.9%
29/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
18.8%
15/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
General disorders
Oedema Peripheral
|
29.5%
23/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
16.9%
14/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
17.5%
14/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
General disorders
Pyrexia
|
12.8%
10/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
14.5%
12/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
12.5%
10/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
General disorders
Non-cardiac Chest Pain
|
5.1%
4/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
3.6%
3/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.5%
2/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
25.6%
20/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
14.5%
12/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
26.2%
21/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Respiratory Tract Infection
|
16.7%
13/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
9.6%
8/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
10.0%
8/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
14.1%
11/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
9.6%
8/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.5%
2/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Bronchitis
|
11.5%
9/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
9.6%
8/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Conjunctivitis
|
6.4%
5/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
4.8%
4/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
5.1%
4/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Gastroenteritis
|
2.6%
2/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
5.0%
4/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
2/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
7.2%
6/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
10.0%
8/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Pneumonia
|
2.6%
2/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
6.0%
5/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
5.0%
4/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Infections and infestations
Influenza
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
4.8%
4/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
7.5%
6/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Investigations
Platelet Count Decreased
|
14.1%
11/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
10.8%
9/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
6.2%
5/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Investigations
Blood Creatinine Increased
|
11.5%
9/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
8.4%
7/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
5.0%
4/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
10.3%
8/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.4%
2/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.5%
2/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Investigations
C-Reactive Protein Increased
|
5.1%
4/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
3.6%
3/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Investigations
Neutrophil Count Decreased
|
5.1%
4/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.5%
2/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Investigations
White Blood Cell Count Decreased
|
5.1%
4/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Investigations
Weight Decreased
|
7.7%
6/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
6.0%
5/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
3.8%
3/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Investigations
Aspartate Aminotransferase Increased
|
6.4%
5/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.4%
2/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Investigations
Weight Increased
|
2.6%
2/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
7.2%
6/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
17.9%
14/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
10.8%
9/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
8.8%
7/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
16.7%
13/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
19.3%
16/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
12.5%
10/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.0%
7/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
3.6%
3/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
5.0%
4/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.7%
6/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
7.2%
6/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.5%
2/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.1%
4/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
8.4%
7/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
3.8%
3/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
3/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.4%
2/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
5.0%
4/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.5%
9/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
9.6%
8/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
12.5%
10/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
11.5%
9/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
4.8%
4/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
8.8%
7/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
6.4%
5/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
6.0%
5/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
6.4%
5/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
7.2%
6/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
5.0%
4/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
3/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
13.3%
11/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
6.2%
5/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
3.8%
3/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
6.0%
5/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
2.6%
2/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
7.2%
6/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
6.2%
5/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.4%
2/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
6.2%
5/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Nervous system disorders
Neuropathy Peripheral
|
25.6%
20/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
26.5%
22/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
17.5%
14/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
20.5%
16/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
10.8%
9/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
13.8%
11/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Nervous system disorders
Dizziness
|
16.7%
13/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
14.5%
12/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
6.2%
5/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Nervous system disorders
Headache
|
9.0%
7/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
7.2%
6/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
3.8%
3/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Nervous system disorders
Paraesthesia
|
5.1%
4/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
6.0%
5/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
5.0%
4/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Nervous system disorders
Polyneuropathy
|
3.8%
3/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
6.0%
5/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
6.2%
5/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Nervous system disorders
Dysgeusia
|
1.3%
1/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.4%
2/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
5.0%
4/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
7.2%
6/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Psychiatric disorders
Insomnia
|
9.0%
7/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
24.1%
20/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
13.8%
11/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Psychiatric disorders
Depression
|
5.1%
4/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
3.8%
3/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
0.00%
0/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
6.2%
5/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
12/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
15.7%
13/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
20.0%
16/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.1%
11/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
9.6%
8/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
10.0%
8/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
6/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
4.8%
4/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
3.8%
3/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.1%
4/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
3.6%
3/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.5%
2/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.1%
4/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.4%
2/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.4%
5/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.4%
2/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
2/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
7.2%
6/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
3.8%
3/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Vascular disorders
Hypotension
|
9.0%
7/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
7.2%
6/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Vascular disorders
Hypertension
|
7.7%
6/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
4.8%
4/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
6.2%
5/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
6.2%
5/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.0%
7/78 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
1.2%
1/83 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
2.5%
2/80 • Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor's agreements with investigators require proposed public disclosures of trial results to be submitted to Sponsor for review prior to publication. Sponsor may request deletion of confidential information or a delay in publication to address intellectual property concerns, but Sponsor may not suppress publication of the trial results indefinitely. Sponsor may request delay of a single-center publication until after the release of a multi-site publication or an agreed upon period of time.
- Publication restrictions are in place
Restriction type: OTHER