Trial Outcomes & Findings for All Japanese Population: Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma (NCT NCT06956170)
NCT ID: NCT06956170
Last Updated: 2025-06-11
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
21 participants
Primary outcome timeframe
Up to approximately 120 weeks
Results posted on
2025-06-11
Participant Flow
This study enrolled a total of 12 Japanese participants and the analyses included 9 Japanese participants that had been previously enrolled in the global study for 207499 (NCT04484623), resulting in a total of 21 participants.
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
Japanese 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.
|
Bortezomib + Pomalidomide + Dexamethasone
Japanese participants with RRMM received 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+ in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, 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
|
10
|
11
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
Reasons for withdrawal
| Measure |
Belantamab Mafodotin+Pomalidomide+Dexamethasone
Japanese 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.
|
Bortezomib + Pomalidomide + Dexamethasone
Japanese participants with RRMM received 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+ in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, 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
Death
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Ongoing
|
7
|
10
|
Baseline Characteristics
All Japanese Population: 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=10 Participants
Japanese 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.
|
Bortezomib + Pomalidomide + Dexamethasone
n=11 Participants
Japanese participants with RRMM received 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+ in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, 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=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.6 YEARS
STANDARD_DEVIATION 5.95 • n=99 Participants
|
72.5 YEARS
STANDARD_DEVIATION 5.70 • n=107 Participants
|
72.6 YEARS
STANDARD_DEVIATION 5.67 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian- Japanese Heritage
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 120 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=10 Participants
Japanese 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.
|
Bortezomib + Pomalidomide + Dexamethasone
n=11 Participants
Japanese participants with RRMM received 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+ in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, 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 0.2 to
The median and upper limit of 95% Confidence Interval were not estimable due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
|
14.8 Months
Interval 1.9 to
The upper limit of 95% Confidence Interval was not estimable due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
|
SECONDARY outcome
Timeframe: Up to approximately 407 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 407 weeksDuration of Response (DoR) defined as the time from first documented evidence of partial response (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 407 weeksMRD negativity rate defined as the percentage of participants who achieve MRD negative status (as assessed by NGS 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 407 weeksORR is 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 407 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 407 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 407 weeksTime to Best Response (TTBR) 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 407 weeksTime to Response (TTR) 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 407 weeksTime to Progression (TTP) 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 407 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 407 weeksAn AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 407 weeksBlood samples will be collected for the analysis of hematology parameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 407 weeksBlood samples will be collected for the analysis of clinical chemistry parameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 407 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 407 weeksBlood samples will be collected for PK analysis of belantamab mafodotin.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 407 weeksBlood samples will be collected for PK analysis of belantamab mafodotin.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 407 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 407 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 407 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 407 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 407 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 407 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 407 weeksSerum samples will be 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 407 weeksSerum samples will be collected for the analysis of the presence of ADAs using validated immunoassays. All samples will 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 407 weeksThe PRO-CTCAE is a patient-reported outcome measure that was developed to evaluate symptomatic toxicities in patients in cancer clinical trials; it characterizes the frequency, severity, interference, and presence or absence of symptomatic toxicities. Responses ranges from 0 ("never," "none," "not at all," or "absent") to 4 ("almost constantly," "very severe," or "very much"), with a higher score indicating a higher frequency, severity, or interference of adverse events.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to approximately 407 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 represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent 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: Baseline and up to approximately 407 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 to 100. 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. 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: Baseline and up to approximately 407 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 to 100. A high score for disease symptoms represents a high level of symptomatology or problems. 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
Adverse Events
Belantamab Mafodotin+Pomalidomide+Dexamethasone
Serious events: 5 serious events
Other events: 10 other events
Deaths: 2 deaths
Bortezomib + Pomalidomide + Dexamethasone
Serious events: 4 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Belantamab Mafodotin+Pomalidomide+Dexamethasone
n=10 participants at risk
Japanese 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.
|
Bortezomib + Pomalidomide + Dexamethasone
n=11 participants at risk
Japanese participants with RRMM received 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+ in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, 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.
|
|---|---|---|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Eye disorders
Cataract
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
General disorders
Oedema
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Hepatobiliary disorders
Cholelithiasis
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Cytomegalovirus chorioretinitis
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Influenza
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Morganella infection
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included 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%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
Other adverse events
| Measure |
Belantamab Mafodotin+Pomalidomide+Dexamethasone
n=10 participants at risk
Japanese 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.
|
Bortezomib + Pomalidomide + Dexamethasone
n=11 participants at risk
Japanese participants with RRMM received 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+ in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, 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.
|
|---|---|---|
|
Eye disorders
Vision blurred
|
90.0%
9/10 • Number of events 17 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Eye disorders
Vitreous floaters
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Gastrointestinal disorders
Constipation
|
50.0%
5/10 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
63.6%
7/11 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
4/10 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
18.2%
2/11 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
1/10 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
30.0%
3/10 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
36.4%
4/11 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Eye disorders
Cataract
|
30.0%
3/10 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Eye disorders
Dry eye
|
20.0%
2/10 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Eye disorders
Eye discharge
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Eye disorders
Eye irritation
|
20.0%
2/10 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Eye disorders
Eye pain
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Eye disorders
Foreign body sensation in eyes
|
40.0%
4/10 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Eye disorders
Glaucoma
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Eye disorders
Photophobia
|
10.0%
1/10 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
27.3%
3/11 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Gastrointestinal disorders
Periodontal disease
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
General disorders
Injection site reaction
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
27.3%
3/11 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
General disorders
Localised oedema
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
General disorders
Malaise
|
30.0%
3/10 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
General disorders
Oedema
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
General disorders
Oedema peripheral
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
36.4%
4/11 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Immune system disorders
Hypogammaglobulinaemia
|
30.0%
3/10 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Bacteraemia
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Bacterial infection
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Bronchitis
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
COVID-19
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Cystitis
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Dermatophytosis of nail
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Herpes zoster
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Infection
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Influenza
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Otitis externa
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Otitis media
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Renal abscess
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Sepsis
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Streptococcal infection
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
2/10 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Injury, poisoning and procedural complications
Oral contusion
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Investigations
Alanine aminotransferase increased
|
60.0%
6/10 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
18.2%
2/11 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Investigations
Albumin urine present
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
4/10 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Investigations
Basophil count increased
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Investigations
Blood alkaline phosphatase increased
|
30.0%
3/10 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
18.2%
2/11 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Investigations
Blood lactate dehydrogenase increased
|
10.0%
1/10 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Investigations
Coagulation test abnormal
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Investigations
Cytomegalovirus test positive
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Investigations
Gamma-glutamyltransferase increased
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Investigations
Lymphocyte count decreased
|
10.0%
1/10 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
27.3%
3/11 • Number of events 27 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Investigations
Neutrophil count decreased
|
30.0%
3/10 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
45.5%
5/11 • Number of events 45 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Investigations
Neutrophil count increased
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Investigations
Platelet count decreased
|
30.0%
3/10 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
36.4%
4/11 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Investigations
Weight decreased
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Investigations
White blood cell count decreased
|
10.0%
1/10 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
36.4%
4/11 • Number of events 28 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
2/10 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
27.3%
3/11 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Nervous system disorders
Aphasia
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Nervous system disorders
Cognitive disorder
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Nervous system disorders
Dizziness
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
27.3%
3/11 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Nervous system disorders
Hypoaesthesia
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Nervous system disorders
Tremor
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Renal and urinary disorders
Neurogenic bladder
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Renal and urinary disorders
Pollakiuria
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.0%
3/10 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Vascular disorders
Flushing
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included 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