Trial Outcomes & Findings for Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma (NCT NCT04484623)
NCT ID: NCT04484623
Last Updated: 2025-03-18
Results Overview
PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD is defined as increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5 grams per deciliter {g/dL}\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200 milligrams per 24 hours {mg/24h}\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels \[absolute increase \>10mg/dL\]; appearance of new lesion,\>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1 centimeter (cm) in short axis.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
302 participants
Primary outcome timeframe
Up to approximately 174 weeks
Results posted on
2025-03-18
Participant Flow
The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Participant milestones
| Measure |
Belantamab Mafodotin+Pomalidomide+Dexamethasone
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
|
Pomalidomide+Bortezomib+Dexamethasone
Participants with RRMM received oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, in combination with subcutaneous (SC) injection of 1.3 mg/meter\^2(m\^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
|
|---|---|---|
|
Overall Study
STARTED
|
155
|
147
|
|
Overall Study
Safety Population
|
150
|
145
|
|
Overall Study
COMPLETED
|
48
|
54
|
|
Overall Study
NOT COMPLETED
|
107
|
93
|
Reasons for withdrawal
| Measure |
Belantamab Mafodotin+Pomalidomide+Dexamethasone
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
|
Pomalidomide+Bortezomib+Dexamethasone
Participants with RRMM received oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, in combination with subcutaneous (SC) injection of 1.3 mg/meter\^2(m\^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Deviation
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
11
|
8
|
|
Overall Study
Ongoing
|
94
|
84
|
Baseline Characteristics
Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Belantamab Mafodotin+Pomalidomide+Dexamethasone
n=155 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
|
Pomalidomide+Bortezomib+Dexamethasone
n=147 Participants
Participants with RRMM received oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, in combination with subcutaneous (SC) injection of 1.3 mg/meter\^2(m\^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 YEARS
STANDARD_DEVIATION 8.56 • n=5 Participants
|
66.7 YEARS
STANDARD_DEVIATION 10.03 • n=7 Participants
|
66.1 YEARS
STANDARD_DEVIATION 9.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
133 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
260 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Others
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 174 weeksPopulation: Intent-to-Treat (ITT) Population included all randomized participants whether or not randomized treatment was administered.
PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD is defined as increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5 grams per deciliter {g/dL}\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200 milligrams per 24 hours {mg/24h}\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels \[absolute increase \>10mg/dL\]; appearance of new lesion,\>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1 centimeter (cm) in short axis.
Outcome measures
| Measure |
Belantamab Mafodotin+Pomalidomide+Dexamethasone
n=155 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
|
Pomalidomide+Bortezomib+Dexamethasone
n=147 Participants
Participants with RRMM received oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, in combination with subcutaneous (SC) injection of 1.3 mg/meter\^2(m\^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
NA Months
Interval 20.6 to
NA indicates median and upper limit of 95% CI which were not estimable due to low number of participants with events.
|
12.7 Months
Interval 9.1 to 18.5
|
SECONDARY outcome
Timeframe: Up to approximately 473 weeksOverall Survival (OS) defined as the interval of time from randomization to the date of death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksDuration of Response (DoR) defined as the time from first documented evidence of PR or better until progressive disease (PD) or death due to any cause. Response will be based on IRC-assessment per IMWG criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksMRD negativity rate defined as the percentage of participants who achieve MRD negative status (as assessed by next-generation sequencing at 10\^5 threshold) at least once during the time of confirmed CR or better response based on IRC-assessment per IMWG.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksORR will be defined as the percentage of participants with a confirmed partial response or better (i.e., PR, VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksComplete Response Rate (CRR), defined as the percentage of participants with a confirmed complete response (CR) or better (i.e., CR and stringent complete response (sCR)) based on IRC assessment per IMWG criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksVGPR is defined as the percentage of participants with a confirmed VGPR or better (i.e., VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksTTBR defined as the interval of time between the date of randomization and the earliest date of achieving best response among participants with a confirmed PR or better based on IRC-assessment per IMWG.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksTTR defined as the time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve a response (i.e., confirmed PR or better) based on IRC-assessment per IMWG.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksTTP defined as the time from randomization until the earliest date of PD based on IRC-assessment per IMWG criteria, or death due to PD.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksPFS2 defined as time from randomization to disease progression (investigator-assessed response) after initiation of new anti-myeloma therapy or death from any cause, whichever is earlier. If disease progression after new antimyeloma therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any cause, whichever is earlier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksBlood samples will be collected for the analysis of hematology parameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksBlood samples will be collected for the analysis of clinical chemistry parameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksBlood samples will be collected for PK analysis of belantamab mafodotin.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksBlood samples will be collected for PK analysis of belantamab mafodotin.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksBlood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksBlood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksBlood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksBlood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksBlood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksBlood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksSerum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be tested in screening assay, and positive samples will be further characterized for antibody titers.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksSerum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be to be further tested in screening assay, and positive samples will be further characterized for antibody titers.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksThe PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksThe EORTC QLQ-C30 includes 30-items with single and multi-item scales. These includes five functional scales (physical functioning \[PF\], role functioning \[RF\], cognitive functioning \[CF\], emotional functioning \[EF\] and social functioning \[SF\]), three symptom scales (fatigue, pain and nausea/vomiting \[N/V\]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhoea, insomnia, dyspnoea, appetite loss \[AL\] and financial difficulties \[FD\]). Response options are 1 to 4. Scores are averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represents better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represents significant symptomatology. Baseline is defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline is calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksThe EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score for Future Perspective and Body Image represents a high/healthy level of functioning.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 473 weeksThe EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. For the EORTC IL52, disease symptoms domain of the QLQ-MY20 will be used for bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score for Future Perspective and Body Image represents a high/healthy level of functioning.
Outcome measures
Outcome data not reported
Adverse Events
Belantamab Mafodotin+Pomalidomide+Dexamethasone
Serious events: 95 serious events
Other events: 148 other events
Deaths: 48 deaths
Pomalidomide+Bortezomib+Dexamethasone
Serious events: 65 serious events
Other events: 130 other events
Deaths: 54 deaths
Serious adverse events
| Measure |
Belantamab Mafodotin+Pomalidomide+Dexamethasone
n=150 participants at risk
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
|
Pomalidomide+Bortezomib+Dexamethasone
n=145 participants at risk
Participants with RRMM received oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, in combination with subcutaneous (SC) injection of 1.3 mg/meter\^2(m\^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.3%
5/150 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
2.1%
3/145 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.0%
9/150 • Number of events 13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
2.8%
4/145 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
3.4%
5/145 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Cardiac disorders
Angina pectoris
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Cardiac disorders
Atrial fibrillation
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
2.1%
3/145 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
2.1%
3/145 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Cardiac disorders
Myocardial infarction
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Eye disorders
Cataract
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Eye disorders
Diplopia
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Gastrointestinal disorders
Ascites
|
1.3%
2/150 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Gastrointestinal disorders
Constipation
|
0.67%
1/150 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.3%
2/150 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Gastrointestinal disorders
Volvulus
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
General disorders
Chest pain
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
General disorders
Death
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
2.1%
3/145 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
General disorders
Device related thrombosis
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
General disorders
General physical health deterioration
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
General disorders
Generalised oedema
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
General disorders
Oedema
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
General disorders
Pyrexia
|
1.3%
2/150 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
1.4%
2/145 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
1.3%
2/150 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Atypical pneumonia
|
1.3%
2/150 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
1.4%
2/145 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Bronchitis
|
1.3%
2/150 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
COVID-19
|
6.7%
10/150 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
2.8%
4/145 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
COVID-19 pneumonia
|
11.3%
17/150 • Number of events 18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
4.1%
6/145 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Candida sepsis
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Cytomegalovirus infection
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Device related infection
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Encephalitis
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Gastroenteritis
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Herpes zoster
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Influenza
|
1.3%
2/150 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
1.4%
2/145 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Klebsiella infection
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Meningoencephalitis bacterial
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Meningoencephalitis herpetic
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Neutropenic sepsis
|
1.3%
2/150 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
1.4%
2/145 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Oral candidiasis
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Parvovirus B19 infection
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
2.0%
3/150 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Pneumonia
|
18.0%
27/150 • Number of events 33 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
7.6%
11/145 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Pneumonia aspiration
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Pneumonia bacterial
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Pneumonia influenzal
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
1.3%
2/150 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Polyomavirus-associated nephropathy
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Pseudomembranous colitis
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Pseudomonas infection
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.3%
2/150 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Respiratory tract infection
|
2.0%
3/150 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Rhinovirus infection
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
1.4%
2/145 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Sepsis
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
2.1%
3/145 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Septic shock
|
1.3%
2/150 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Staphylococcal infection
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Streptococcal sepsis
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Tooth infection
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
2/150 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Urinary tract infection
|
3.3%
5/150 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Urosepsis
|
1.3%
2/150 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Varicella
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Viral infection
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Visceral leishmaniasis
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
0.67%
1/150 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Injury, poisoning and procedural complications
Fall
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Investigations
Blood creatinine increased
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Investigations
Neutrophil count decreased
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Investigations
Platelet count decreased
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Investigations
White blood cell count decreased
|
1.3%
2/150 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc space narrowing
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder adenocarcinoma
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Nervous system disorders
Autonomic neuropathy
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Nervous system disorders
Balance disorder
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Nervous system disorders
Cerebral infarction
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Nervous system disorders
Syncope
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Psychiatric disorders
Confusional state
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Psychiatric disorders
Suicide attempt
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
3/150 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
2.8%
4/145 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Renal and urinary disorders
Glomerulonephritis rapidly progressive
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Renal and urinary disorders
Polyuria
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
3/150 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
2.8%
4/145 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Vascular disorders
Deep vein thrombosis
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Vascular disorders
Hypertension
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Vascular disorders
Hypotension
|
0.67%
1/150 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/150 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
Other adverse events
| Measure |
Belantamab Mafodotin+Pomalidomide+Dexamethasone
n=150 participants at risk
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
|
Pomalidomide+Bortezomib+Dexamethasone
n=145 participants at risk
Participants with RRMM received oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, in combination with subcutaneous (SC) injection of 1.3 mg/meter\^2(m\^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
|
|---|---|---|
|
Investigations
Neutrophil count decreased
|
20.0%
30/150 • Number of events 116 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
13.1%
19/145 • Number of events 100 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Blood and lymphatic system disorders
Anaemia
|
23.3%
35/150 • Number of events 52 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
25.5%
37/145 • Number of events 63 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Blood and lymphatic system disorders
Neutropenia
|
46.0%
69/150 • Number of events 206 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
33.1%
48/145 • Number of events 191 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
36.0%
54/150 • Number of events 113 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
27.6%
40/145 • Number of events 99 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Eye disorders
Cataract
|
26.7%
40/150 • Number of events 56 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
9.7%
14/145 • Number of events 16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Eye disorders
Corneal epithelial microcysts
|
22.7%
34/150 • Number of events 51 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Eye disorders
Corneal opacity
|
8.7%
13/150 • Number of events 23 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Eye disorders
Dry eye
|
60.7%
91/150 • Number of events 232 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
9.7%
14/145 • Number of events 17 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Eye disorders
Eye irritation
|
50.0%
75/150 • Number of events 198 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
9.0%
13/145 • Number of events 16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Eye disorders
Eye pain
|
32.7%
49/150 • Number of events 100 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
4.8%
7/145 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Eye disorders
Foreign body sensation in eyes
|
60.7%
91/150 • Number of events 257 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
6.2%
9/145 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Eye disorders
Keratitis
|
5.3%
8/150 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Eye disorders
Keratopathy
|
7.3%
11/150 • Number of events 14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.00%
0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Eye disorders
Lacrimation increased
|
6.0%
9/150 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
2.8%
4/145 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Eye disorders
Photophobia
|
44.0%
66/150 • Number of events 168 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
4.1%
6/145 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Eye disorders
Punctate keratitis
|
22.7%
34/150 • Number of events 63 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
0.69%
1/145 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Eye disorders
Vision blurred
|
79.3%
119/150 • Number of events 426 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
15.2%
22/145 • Number of events 24 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Eye disorders
Visual acuity reduced
|
22.7%
34/150 • Number of events 62 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
5.5%
8/145 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Eye disorders
Visual impairment
|
15.3%
23/150 • Number of events 54 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
1.4%
2/145 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Gastrointestinal disorders
Constipation
|
14.7%
22/150 • Number of events 35 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
22.8%
33/145 • Number of events 42 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Gastrointestinal disorders
Diarrhoea
|
22.7%
34/150 • Number of events 56 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
22.1%
32/145 • Number of events 50 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Gastrointestinal disorders
Nausea
|
12.0%
18/150 • Number of events 28 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
10.3%
15/145 • Number of events 16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
General disorders
Asthenia
|
10.0%
15/150 • Number of events 26 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
13.8%
20/145 • Number of events 29 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
General disorders
Fatigue
|
26.7%
40/150 • Number of events 45 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
22.1%
32/145 • Number of events 39 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
General disorders
Oedema peripheral
|
10.7%
16/150 • Number of events 21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
15.9%
23/145 • Number of events 26 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
General disorders
Pyrexia
|
18.7%
28/150 • Number of events 41 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
6.2%
9/145 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Immune system disorders
Hypogammaglobulinaemia
|
5.3%
8/150 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
4.1%
6/145 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Bronchitis
|
7.3%
11/150 • Number of events 14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
4.1%
6/145 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
COVID-19
|
32.0%
48/150 • Number of events 57 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
18.6%
27/145 • Number of events 30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Infection
|
2.0%
3/150 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
5.5%
8/145 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
9/150 • Number of events 15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
4.8%
7/145 • Number of events 13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Pneumonia
|
8.7%
13/150 • Number of events 15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
6.2%
9/145 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Upper respiratory tract infection
|
26.0%
39/150 • Number of events 64 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
17.2%
25/145 • Number of events 46 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Infections and infestations
Urinary tract infection
|
13.3%
20/150 • Number of events 36 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
9.0%
13/145 • Number of events 16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Investigations
Alanine aminotransferase increased
|
15.3%
23/150 • Number of events 34 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
9.0%
13/145 • Number of events 23 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
15/150 • Number of events 20 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
7.6%
11/145 • Number of events 15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Investigations
Blood alkaline phosphatase increased
|
5.3%
8/150 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
4.1%
6/145 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Investigations
Blood creatinine increased
|
6.0%
9/150 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
3.4%
5/145 • Number of events 14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.7%
10/150 • Number of events 15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
2.1%
3/145 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Investigations
Platelet count decreased
|
20.0%
30/150 • Number of events 55 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
14.5%
21/145 • Number of events 40 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.0%
9/150 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
6.2%
9/145 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.0%
9/150 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
2.8%
4/145 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.3%
11/150 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
6.9%
10/145 • Number of events 16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.7%
13/150 • Number of events 15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
7.6%
11/145 • Number of events 14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.7%
16/150 • Number of events 20 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
14.5%
21/145 • Number of events 27 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.3%
8/150 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
2.8%
4/145 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.7%
10/150 • Number of events 13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
5.5%
8/145 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.7%
13/150 • Number of events 15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
5.5%
8/145 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Nervous system disorders
Dizziness
|
6.0%
9/150 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
11.7%
17/145 • Number of events 20 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Nervous system disorders
Headache
|
6.0%
9/150 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
5.5%
8/145 • Number of events 13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Nervous system disorders
Neuropathy peripheral
|
7.3%
11/150 • Number of events 16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
23.4%
34/145 • Number of events 44 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.3%
5/150 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
10.3%
15/145 • Number of events 22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Nervous system disorders
Tremor
|
6.0%
9/150 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
3.4%
5/145 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Psychiatric disorders
Insomnia
|
13.3%
20/150 • Number of events 23 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
12.4%
18/145 • Number of events 20 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
20/150 • Number of events 28 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
7.6%
11/145 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.3%
26/150 • Number of events 29 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
7.6%
11/145 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.3%
11/150 • Number of events 14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
3.4%
5/145 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.0%
6/150 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
6.9%
10/145 • Number of events 14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.3%
11/150 • Number of events 13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
1.4%
2/145 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER