Trial Outcomes & Findings for A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype (NCT NCT04718389)
NCT ID: NCT04718389
Last Updated: 2026-05-18
Results Overview
Clinically significant exacerbations recorded were defined as worsening of asthma requiring the use of systemic corticosteroids (CS) \[such as intramuscular (IM), intravenous (IV) or oral\] and/or hospitalization and/or Emergency Department (ED) visit. For all participants, IV or oral steroids (e.g., prednisone) for at least 3 days or a single IM corticosteroid dose is required. For participants on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required. Exacerbations recorded in the electronic case report form (eCRF) were considered as verified clinically significant exacerbations and included in the primary analysis. Exacerbations separated by less than 7 days was treated as a continuation of the same exacerbation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1717 participants
Primary outcome timeframe
Up to Week 52
Results posted on
2026-05-18
Participant Flow
A total of 1717 participants were randomized to the study out of which 1687 participants were included in Full Analysis Set (FAS). FAS population included all randomised participants who received at least one dose of study intervention excluding 27 participants from 4 sites with Good Clinical Practices (GCP) non-compliance/significant data integrity concerns and 3 were randomized in error but did not receive study intervention.
A total of 1717 participants were randomized in the study.
Participant milestones
| Measure |
Depemokimab 100mg SC
Participants received GSK3511294 (Depemokimab) 100 milligrams (mg) subcutaneous (SC) injection administered every 26 weeks (week 0 and week 26) alongside placebo SC treatment matching the active comparator (participant's anti-IL-5/5R treatment prior to randomisation: either placebo matching mepolizumab every 4 weeks or placebo matching benralizumab every 8 weeks).
|
Mepolizumab 100 mg / Benralizumab 30 mg SC
Participants received their existing active comparator (either mepolizumab 100 mg every 4 weeks or benralizumab 30 mg every 8 weeks) according to the participant's treatment prior to randomisation plus placebo SC matching GSK3511294 (Depemokimab) administered every 26 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
859
|
858
|
|
Overall Study
FAS
|
848
|
839
|
|
Overall Study
Safety-modified Set
|
859
|
855
|
|
Overall Study
COMPLETED
|
763
|
772
|
|
Overall Study
NOT COMPLETED
|
96
|
86
|
Reasons for withdrawal
| Measure |
Depemokimab 100mg SC
Participants received GSK3511294 (Depemokimab) 100 milligrams (mg) subcutaneous (SC) injection administered every 26 weeks (week 0 and week 26) alongside placebo SC treatment matching the active comparator (participant's anti-IL-5/5R treatment prior to randomisation: either placebo matching mepolizumab every 4 weeks or placebo matching benralizumab every 8 weeks).
|
Mepolizumab 100 mg / Benralizumab 30 mg SC
Participants received their existing active comparator (either mepolizumab 100 mg every 4 weeks or benralizumab 30 mg every 8 weeks) according to the participant's treatment prior to randomisation plus placebo SC matching GSK3511294 (Depemokimab) administered every 26 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
12
|
6
|
|
Overall Study
Lost to Follow-up
|
16
|
7
|
|
Overall Study
Protocol Violation
|
8
|
3
|
|
Overall Study
Physician Decision
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
37
|
44
|
|
Overall Study
Subject reached protocol defined stopping criteria
|
3
|
0
|
|
Overall Study
GCP violation sites
|
11
|
16
|
|
Overall Study
No study intervention received
|
0
|
3
|
Baseline Characteristics
A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype
Baseline characteristics by cohort
| Measure |
Depemokimab 100mg SC
n=848 Participants
Participants received GSK3511294 (Depemokimab) 100 milligrams (mg) subcutaneous (SC) injection administered every 26 weeks (week 0 and week 26) alongside placebo SC treatment matching the active comparator (participant's anti-IL-5/5R treatment prior to randomisation: either placebo matching mepolizumab every 4 weeks or placebo matching benralizumab every 8 weeks).
|
Mepolizumab 100 mg / Benralizumab 30 mg SC
n=839 Participants
Participants received their existing active comparator (either mepolizumab 100 mg every 4 weeks or benralizumab 30 mg every 8 weeks) according to the participant's treatment prior to randomisation plus placebo SC matching GSK3511294 (Depemokimab) administered every 26 weeks.
|
Total
n=1687 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.3 YEARS
STANDARD_DEVIATION 13.24 • n=11 Participants
|
58.9 YEARS
STANDARD_DEVIATION 13.24 • n=9 Participants
|
58.6 YEARS
STANDARD_DEVIATION 13.24 • n=20 Participants
|
|
Sex: Female, Male
Female
|
528 Participants
n=11 Participants
|
522 Participants
n=9 Participants
|
1050 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
320 Participants
n=11 Participants
|
317 Participants
n=9 Participants
|
637 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
AMERICAN INDIAN OR ALASKA NATIVE
|
3 Participants
n=11 Participants
|
3 Participants
n=9 Participants
|
6 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
148 Participants
n=11 Participants
|
140 Participants
n=9 Participants
|
288 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
26 Participants
n=11 Participants
|
35 Participants
n=9 Participants
|
61 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
|
2 Participants
n=11 Participants
|
4 Participants
n=9 Participants
|
6 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
659 Participants
n=11 Participants
|
645 Participants
n=9 Participants
|
1304 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
MIXED RACE
|
5 Participants
n=11 Participants
|
5 Participants
n=9 Participants
|
10 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Other: Unspecified
|
5 Participants
n=11 Participants
|
7 Participants
n=9 Participants
|
12 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Up to Week 52Population: The FAS included all randomized participants who received at least one dose of study intervention excluding participants from sites with GCP violations. Participants were analyzed according to the intervention they were allocated at randomization. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Clinically significant exacerbations recorded were defined as worsening of asthma requiring the use of systemic corticosteroids (CS) \[such as intramuscular (IM), intravenous (IV) or oral\] and/or hospitalization and/or Emergency Department (ED) visit. For all participants, IV or oral steroids (e.g., prednisone) for at least 3 days or a single IM corticosteroid dose is required. For participants on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required. Exacerbations recorded in the electronic case report form (eCRF) were considered as verified clinically significant exacerbations and included in the primary analysis. Exacerbations separated by less than 7 days was treated as a continuation of the same exacerbation.
Outcome measures
| Measure |
Depemokimab 100mg SC
n=813 Participants
Participants received GSK3511294 (Depemokimab) 100 milligrams (mg) subcutaneous (SC) injection administered every 26 weeks (week 0 and week 26) alongside placebo SC treatment matching the active comparator (participant's anti-IL-5/5R treatment prior to randomisation: either placebo matching mepolizumab every 4 weeks or placebo matching benralizumab every 8 weeks).
|
Mepolizumab 100 mg / Benralizumab 30 mg SC
n=803 Participants
Participants received their existing active comparator (either mepolizumab 100 mg every 4 weeks or benralizumab 30 mg every 8 weeks) according to the participant's treatment prior to randomisation plus placebo SC matching GSK3511294 (Depemokimab) administered every 26 weeks.
|
|---|---|---|
|
Annualized Rate of Clinically Significant Exacerbations Over 52 Weeks
|
0.57 Exacerbation per participant per year
Interval 0.5 to 0.64
|
0.49 Exacerbation per participant per year
Interval 0.43 to 0.55
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) up to Week 52Population: The FAS included all randomized participants who received at least one dose of study intervention excluding participants from sites with GCP violations. Participants were analyzed according to the intervention they were allocated at randomization. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. Least Square (LS) mean represents the weighted mean change from baseline values.
SGRQ: validated, disease specific questionnaire comprising of 51 questions designed to measure health related quality of life in participants with disease of airway obstruction. It assesses how respiratory symptoms and limitations affect daily life. SGRQ 3 domains: Symptoms, Activity and, Impacts. Each item has an empirically derived weight, and domain scores are combined to produce a total score ranging: 0 to 100. Scores are expressed as a percentage of overall impairment between 100 (worst possible health status) and 0 (best possible health status). Higher scores indicating greater impairment of quality of life. Change from Baseline (CFB): value at indicated time point minus Baseline value. For each participant, WM CFB in SGRQ total score was calculated using linear trapezoidal rule to estimate area under the curve (AUC) from Baseline (Day 1) across Weeks 4, 12, 26, and 52 and presented as a single consolidated SGRQ total score on original scale (i.e., not expressed per unit time).
Outcome measures
| Measure |
Depemokimab 100mg SC
n=765 Participants
Participants received GSK3511294 (Depemokimab) 100 milligrams (mg) subcutaneous (SC) injection administered every 26 weeks (week 0 and week 26) alongside placebo SC treatment matching the active comparator (participant's anti-IL-5/5R treatment prior to randomisation: either placebo matching mepolizumab every 4 weeks or placebo matching benralizumab every 8 weeks).
|
Mepolizumab 100 mg / Benralizumab 30 mg SC
n=755 Participants
Participants received their existing active comparator (either mepolizumab 100 mg every 4 weeks or benralizumab 30 mg every 8 weeks) according to the participant's treatment prior to randomisation plus placebo SC matching GSK3511294 (Depemokimab) administered every 26 weeks.
|
|---|---|---|
|
Weighted Mean (WM) Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score
|
-0.69 Scores on Scale
Standard Error 0.476
|
-0.86 Scores on Scale
Standard Error 0.486
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) up to Week 52Population: The FAS included all randomized participants who received at least one dose of study intervention excluding participants from sites with GCP violations. Participants were analyzed according to the intervention they were allocated at randomization. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. LS mean represents the weighted mean change from baseline values.
The ACQ 5 is a validated, 5-item patient reported tool assessing asthma symptoms over the past week. The 5 questions enquired to recall how their asthma had been during the previous week and to respond about the frequency and/or severity of symptoms (nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheezing). Each item is scored from 0 (no impairment) to 6 (maximum impairment), and the final ACQ 5 score is the average of all items, ranging from 0 to 6. Lower scores indicate better asthma control, while higher scores indicate poorer control. CFB was defined as value at the indicated time point minus Baseline value. For each participant, the WM CFB in ACQ-5 score was calculated using the linear trapezoidal rule to estimate the AUC from Baseline (Day 1) across Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48 and 52) and presented as a single consolidated ACQ-5 score on the original scale (i.e., not expressed per unit/time).
Outcome measures
| Measure |
Depemokimab 100mg SC
n=773 Participants
Participants received GSK3511294 (Depemokimab) 100 milligrams (mg) subcutaneous (SC) injection administered every 26 weeks (week 0 and week 26) alongside placebo SC treatment matching the active comparator (participant's anti-IL-5/5R treatment prior to randomisation: either placebo matching mepolizumab every 4 weeks or placebo matching benralizumab every 8 weeks).
|
Mepolizumab 100 mg / Benralizumab 30 mg SC
n=758 Participants
Participants received their existing active comparator (either mepolizumab 100 mg every 4 weeks or benralizumab 30 mg every 8 weeks) according to the participant's treatment prior to randomisation plus placebo SC matching GSK3511294 (Depemokimab) administered every 26 weeks.
|
|---|---|---|
|
Weighted Mean Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score
|
0.03 Scores on Scale
Standard Error 0.026
|
0.06 Scores on Scale
Standard Error 0.026
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) up to Week 52Population: The FAS included all randomized participants who received at least one dose of study intervention excluding participants from sites with GCP violations. Participants were analyzed according to the intervention they were allocated at randomization. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. LS mean represents the weighted mean change from baseline values.
Forced Expiratory Volume in One Second (FEV1) is defined as the volume of air that can be forced out in one second after taking a deep breath by a person and was measured by spirometry testing. Change from Baseline in clinic pre-bronchodilator FEV1 was determined. Change from Baseline was defined as value at the indicated time point minus Baseline value. For each participant, the WM change from baseline in FEV1 was calculated using the linear trapezoidal rule to estimate the AUC from Baseline (Day 1) across Weeks 12, 26, 40, and 52). WM change from baseline in FEV1 over 52-week period was presented as a single consolidated data.
Outcome measures
| Measure |
Depemokimab 100mg SC
n=795 Participants
Participants received GSK3511294 (Depemokimab) 100 milligrams (mg) subcutaneous (SC) injection administered every 26 weeks (week 0 and week 26) alongside placebo SC treatment matching the active comparator (participant's anti-IL-5/5R treatment prior to randomisation: either placebo matching mepolizumab every 4 weeks or placebo matching benralizumab every 8 weeks).
|
Mepolizumab 100 mg / Benralizumab 30 mg SC
n=782 Participants
Participants received their existing active comparator (either mepolizumab 100 mg every 4 weeks or benralizumab 30 mg every 8 weeks) according to the participant's treatment prior to randomisation plus placebo SC matching GSK3511294 (Depemokimab) administered every 26 weeks.
|
|---|---|---|
|
Weighted Mean Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)
|
-0.014 Liter
Standard Error 0.0093
|
-0.018 Liter
Standard Error 0.0095
|
Adverse Events
Depemokimab 100mg SC
Serious events: 81 serious events
Other events: 587 other events
Deaths: 0 deaths
Mepolizumab 100 mg / Benralizumab 30 mg SC
Serious events: 76 serious events
Other events: 554 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Depemokimab 100mg SC
n=859 participants at risk
Participants received GSK3511294 (Depemokimab) 100 milligrams (mg) subcutaneous (SC) injection administered every 26 weeks (week 0 and week 26) alongside placebo SC treatment matching the active comparator (participant's anti-IL-5/5R treatment prior to randomisation: either placebo matching mepolizumab every 4 weeks or placebo matching benralizumab every 8 weeks).
|
Mepolizumab 100 mg / Benralizumab 30 mg SC
n=855 participants at risk
Participants received their existing active comparator (either mepolizumab 100 mg every 4 weeks or benralizumab 30 mg every 8 weeks) according to the participant's treatment prior to randomisation plus placebo SC matching GSK3511294 (Depemokimab) administered every 26 weeks.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.23%
2/859 • Number of events 2 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.23%
2/855 • Number of events 2 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Cardiac disorders
Coronary artery disease
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Investigations
Alanine aminotransferase increased
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Investigations
Influenza B virus test positive
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Investigations
Transaminases increased
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Musculoskeletal and connective tissue disorders
Diastasis recti abdominis
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Musculoskeletal and connective tissue disorders
Loose body in joint
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.35%
3/859 • Number of events 3 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.23%
2/859 • Number of events 3 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myelomonocytic leukaemia
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spleen
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Nervous system disorders
Cognitive disorder
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Nervous system disorders
Dementia
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Nervous system disorders
Thunderclap headache
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.23%
2/859 • Number of events 2 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Nervous system disorders
Vertebrobasilar infarction
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 2 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Psychiatric disorders
Anxiety
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Psychiatric disorders
Depression
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Renal and urinary disorders
Calculus bladder
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Renal and urinary disorders
Hypercalciuria
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Renal and urinary disorders
Renal colic
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.2%
19/859 • Number of events 20 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
1.4%
12/855 • Number of events 14 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.23%
2/859 • Number of events 2 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.23%
2/855 • Number of events 2 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Surgical and medical procedures
Orthognathic surgery
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Vascular disorders
Aortic dissection
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Vascular disorders
Peripheral venous disease
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Urosepsis
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Eye disorders
Cataract
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Eye disorders
Blindness
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 2 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Gastrointestinal disorders
Leukoplakia oral
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Gastrointestinal disorders
Proctitis
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
General disorders
Drug withdrawal syndrome
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
General disorders
Nodule
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
General disorders
Oedema peripheral
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Hepatobiliary disorders
Acute cholecystitis necrotic
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Immune system disorders
Anaphylactic reaction
|
0.12%
1/859 • Number of events 2 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Immune system disorders
Contrast media reaction
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Immune system disorders
Drug hypersensitivity
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Appendicitis perforated
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
COVID-19
|
0.81%
7/859 • Number of events 7 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.47%
4/855 • Number of events 4 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Cellulitis
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Chronic sinusitis
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Diverticulitis
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Diverticulitis intestinal haemorrhagic
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Empyema
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Erysipelas
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Infective exacerbation of asthma
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.23%
2/855 • Number of events 2 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Influenza
|
0.35%
3/859 • Number of events 3 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Oral candidiasis
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Otitis media acute
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Otosalpingitis
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Pharyngitis bacterial
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Pneumonia
|
1.3%
11/859 • Number of events 11 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.82%
7/855 • Number of events 7 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Postoperative wound infection
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Pyelitis
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Staphylococcal infection
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Tonsillitis
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.35%
3/855 • Number of events 3 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
0.12%
1/859 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.00%
0/855 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/859 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
0.12%
1/855 • Number of events 1 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
Other adverse events
| Measure |
Depemokimab 100mg SC
n=859 participants at risk
Participants received GSK3511294 (Depemokimab) 100 milligrams (mg) subcutaneous (SC) injection administered every 26 weeks (week 0 and week 26) alongside placebo SC treatment matching the active comparator (participant's anti-IL-5/5R treatment prior to randomisation: either placebo matching mepolizumab every 4 weeks or placebo matching benralizumab every 8 weeks).
|
Mepolizumab 100 mg / Benralizumab 30 mg SC
n=855 participants at risk
Participants received their existing active comparator (either mepolizumab 100 mg every 4 weeks or benralizumab 30 mg every 8 weeks) according to the participant's treatment prior to randomisation plus placebo SC matching GSK3511294 (Depemokimab) administered every 26 weeks.
|
|---|---|---|
|
General disorders
Fatigue
|
3.3%
28/859 • Number of events 33 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
2.7%
23/855 • Number of events 35 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
General disorders
Pyrexia
|
4.4%
38/859 • Number of events 43 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
2.8%
24/855 • Number of events 26 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Bronchitis
|
5.0%
43/859 • Number of events 54 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
3.6%
31/855 • Number of events 33 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
COVID-19
|
18.3%
157/859 • Number of events 162 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
16.7%
143/855 • Number of events 150 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Influenza
|
5.8%
50/859 • Number of events 64 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
4.4%
38/855 • Number of events 43 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Lower respiratory tract infection
|
4.7%
40/859 • Number of events 47 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
4.4%
38/855 • Number of events 52 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Nasopharyngitis
|
20.6%
177/859 • Number of events 271 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
20.0%
171/855 • Number of events 254 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Respiratory tract infection
|
5.5%
47/859 • Number of events 54 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
4.6%
39/855 • Number of events 46 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Sinusitis
|
6.6%
57/859 • Number of events 74 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
5.8%
50/855 • Number of events 57 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.4%
98/859 • Number of events 125 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
13.0%
111/855 • Number of events 157 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Infections and infestations
Urinary tract infection
|
4.9%
42/859 • Number of events 47 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
2.9%
25/855 • Number of events 36 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
37/859 • Number of events 44 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
6.2%
53/855 • Number of events 67 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
42/859 • Number of events 44 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
4.1%
35/855 • Number of events 37 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Nervous system disorders
Headache
|
6.8%
58/859 • Number of events 80 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
7.3%
62/855 • Number of events 90 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.8%
67/859 • Number of events 84 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
4.9%
42/855 • Number of events 43 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.7%
40/859 • Number of events 51 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
4.2%
36/855 • Number of events 41 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.6%
31/859 • Number of events 40 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
2.6%
22/855 • Number of events 24 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Vascular disorders
Hypertension
|
4.7%
40/859 • Number of events 46 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
3.4%
29/855 • Number of events 29 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.9%
25/859 • Number of events 25 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
3.0%
26/855 • Number of events 29 • All cause mortality, SAEs and other AEs were collected from signing of Informed Consent (Day -1) up to week 56 (End of follow up).
Analysis involved Safety-modified population, comprising all randomized participants who received at least one dose of study intervention. Participants were analysed according to the intervention they are allocated at randomisation, unless a participant received a different intervention to the randomised intervention at all protocol-defined administrations at which study medication was received, in which case the participants were analysed according to the actual intervention they received.
|
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