Trial Outcomes & Findings for A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid. (NCT NCT04612790)
NCT ID: NCT04612790
Last Updated: 2024-11-29
Results Overview
A responder was defined as a participant who was in complete remission while off OCS for ≥2 months at Week 36.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
67 participants
Primary outcome timeframe
At Week 36
Results posted on
2024-11-29
Participant Flow
This study was conducted in adult participants with symptomatic bullous pemphigoid (BP) at 32 sites in 11 countries. Study consisted of screening period, double-blind (DB) period in which 67 participants were randomized in 1:1 ratio to either receive benralizumab or placebo for 36 weeks followed by optional open-label extension (OLE) period (for participants who completed the DB period), in which all participants received benralizumab for at least 1 year.
Study was terminated following a pre-planned futility analysis as efficacy results did not pass pre-defined futility hurdle. Prior to futility analysis,AstraZeneca created protocol#5 and Statistical analysis plan(SAP)#3. Updated protocol was never submitted to health authorities as study was terminating. Results align with protocol#5 and SAP#3.
Participant milestones
| Measure |
DB Period: Benralizumab
Participants received benralizumab with an initial loading dose of 60 milligrams (mg) followed by a maintenance dose of 30 mg every 4 weeks (Q4W) as a subcutaneous (SC) injection for 36 weeks.
|
DB Period: Placebo
Participants received volume-matched placebo as a SC injection on the same dosing schedule as benralizumab Q4W for 36 weeks.
|
OLE Period: Benralizumab (DB)/Benralizumab (OLE)
Participants who received benralizumab in DB period received benralizumab 30 mg Q4W in OLE period for at least 1 year.
|
OLE Period: Placebo (DB)/Benralizumab (OLE)-
Participants who received matched placebo in DB period received benralizumab 30 mg Q4W in OLE period for at least 1 year.
|
|---|---|---|---|---|
|
DB Period (Up to 36 Weeks)
STARTED
|
34
|
33
|
0
|
0
|
|
DB Period (Up to 36 Weeks)
COMPLETED
|
16
|
19
|
0
|
0
|
|
DB Period (Up to 36 Weeks)
NOT COMPLETED
|
18
|
14
|
0
|
0
|
|
OLE Period (Up to 1 Year)
STARTED
|
0
|
0
|
16
|
18
|
|
OLE Period (Up to 1 Year)
Randomized But Did Not Receive Treatment in OLE Period
|
0
|
0
|
0
|
1
|
|
OLE Period (Up to 1 Year)
COMPLETED
|
0
|
0
|
0
|
0
|
|
OLE Period (Up to 1 Year)
NOT COMPLETED
|
0
|
0
|
16
|
18
|
Reasons for withdrawal
| Measure |
DB Period: Benralizumab
Participants received benralizumab with an initial loading dose of 60 milligrams (mg) followed by a maintenance dose of 30 mg every 4 weeks (Q4W) as a subcutaneous (SC) injection for 36 weeks.
|
DB Period: Placebo
Participants received volume-matched placebo as a SC injection on the same dosing schedule as benralizumab Q4W for 36 weeks.
|
OLE Period: Benralizumab (DB)/Benralizumab (OLE)
Participants who received benralizumab in DB period received benralizumab 30 mg Q4W in OLE period for at least 1 year.
|
OLE Period: Placebo (DB)/Benralizumab (OLE)-
Participants who received matched placebo in DB period received benralizumab 30 mg Q4W in OLE period for at least 1 year.
|
|---|---|---|---|---|
|
DB Period (Up to 36 Weeks)
Death
|
1
|
1
|
0
|
0
|
|
DB Period (Up to 36 Weeks)
Adverse Event
|
2
|
0
|
0
|
0
|
|
DB Period (Up to 36 Weeks)
Study terminated by sponsor
|
8
|
6
|
0
|
0
|
|
DB Period (Up to 36 Weeks)
Withdrawal by Subject
|
2
|
4
|
0
|
0
|
|
DB Period (Up to 36 Weeks)
Physician Decision
|
4
|
3
|
0
|
0
|
|
DB Period (Up to 36 Weeks)
Other
|
1
|
0
|
0
|
0
|
|
OLE Period (Up to 1 Year)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
OLE Period (Up to 1 Year)
Investigator decision
|
0
|
0
|
2
|
1
|
|
OLE Period (Up to 1 Year)
Study terminated by sponsor
|
0
|
0
|
14
|
15
|
|
OLE Period (Up to 1 Year)
Other
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid.
Baseline characteristics by cohort
| Measure |
DB Period: Benralizumab
n=34 Participants
Participants received benralizumab with an initial loading dose of 60 mg followed by a maintenance dose of 30 mg Q4W as a SC injection for 36 weeks.
|
DB Period: Placebo
n=33 Participants
Participants received volume-matched placebo as a SC injection on the same dosing schedule as benralizumab Q4W for 36 weeks.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.0 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
72.5 Years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
70.2 Years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 36Population: FAS included all randomized participants who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only participants who had the opportunity to reach Week 36 are included in the analysis.
A responder was defined as a participant who was in complete remission while off OCS for ≥2 months at Week 36.
Outcome measures
| Measure |
DB Period: Benralizumab
n=18 Participants
Participants received benralizumab with an initial loading dose of 60 mg followed by a maintenance dose of 30 mg Q4W as a SC injection for 36 weeks.
|
DB Period: Placebo
n=19 Participants
Participants received volume-matched placebo as a SC injection on the same dosing schedule as benralizumab Q4W for 36 weeks.
|
|---|---|---|
|
Percentage of Responders at Week 36
|
11.1 Percentage of participants
Interval -2.7 to 26.11
|
5.26 Percentage of participants
Interval -5.06 to 15.07
|
SECONDARY outcome
Timeframe: Up to Week 36Population: FAS included all randomized participants who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only participants who had the opportunity to reach Week 36 are included in the analysis.
Relapse was defined as the appearance of 3 or more new lesions per month (blisters, eczematous lesions, or urticarial plaques); or at least 1 large (\>10 centimeter \[cm\] diameter) eczematous lesion or urticarial plaques that did not heal within 1 week; or the extension of established lesions or daily pruritus in participants who had achieved disease control.
Outcome measures
| Measure |
DB Period: Benralizumab
n=18 Participants
Participants received benralizumab with an initial loading dose of 60 mg followed by a maintenance dose of 30 mg Q4W as a SC injection for 36 weeks.
|
DB Period: Placebo
n=19 Participants
Participants received volume-matched placebo as a SC injection on the same dosing schedule as benralizumab Q4W for 36 weeks.
|
|---|---|---|
|
Percentage of Participants Who Remained Relapse-Free up to Week 36
|
23.78 Percentage of participants
Interval 5.95 to 41.61
|
19.79 Percentage of participants
Interval 1.43 to 38.15
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 36Population: FAS included all randomized participants who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only participants who had the opportunity to reach Week 36 are included in the analysis.
The cumulative OCS exposure was estimated as the sum over the relevant 4-week periods from the mixed-effect model for repeated measures (MMRM) model. Baseline was defined as the last recorded value on or prior to the date of randomization. Equivalents were prednisone equivalents (converted from mg).
Outcome measures
| Measure |
DB Period: Benralizumab
n=18 Participants
Participants received benralizumab with an initial loading dose of 60 mg followed by a maintenance dose of 30 mg Q4W as a SC injection for 36 weeks.
|
DB Period: Placebo
n=19 Participants
Participants received volume-matched placebo as a SC injection on the same dosing schedule as benralizumab Q4W for 36 weeks.
|
|---|---|---|
|
Cumulative OCS Exposure From Baseline to Week 36
|
71.37 mg per kilogram (mg/kg)
Standard Deviation 63.19
|
62.71 mg per kilogram (mg/kg)
Standard Deviation 46.90
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 36Population: FAS included all randomized participants who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only those participants with data collected at specified timepoints are reported.
BPDAI is a clinician completed tool that is used for independent disease severity assessment to measure disease extent in BP. The total BPDAI activity score is calculated as the arithmetic sum of the 3 subcomponents - cutaneous blisters/erosions, cutaneous urticaria/erythema, and mucosal blisters/erosions. The BPDAI total activity gives an indication of disease activity, with score range from 0 (no disease activity) to 360 (severe disease activity). Higher scores indicating greater disease activity. Baseline was defined as the last recorded value on or prior to the date of randomization.
Outcome measures
| Measure |
DB Period: Benralizumab
n=14 Participants
Participants received benralizumab with an initial loading dose of 60 mg followed by a maintenance dose of 30 mg Q4W as a SC injection for 36 weeks.
|
DB Period: Placebo
n=12 Participants
Participants received volume-matched placebo as a SC injection on the same dosing schedule as benralizumab Q4W for 36 weeks.
|
|---|---|---|
|
Change From Baseline in Bullous Pemphigoid Disease Area Index (BPDAI) Activity Score at Week 36
|
-53.29 Score on a scale
Standard Deviation 46.33
|
-52.75 Score on a scale
Standard Deviation 17.36
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 36Population: FAS included all randomized participants who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only those participants with data collected at specified timepoints are reported.
The BPDAI-Pruritus is a separate component of the BPDAI that asks the participant to grade the severity of pruritus over the past 24 hours, the past week, and the past month. For each recall period, severity of pruritus is rated on a numeric rating scale (NRS) ranging from 0 for no itch to 10 for maximal itching. The BPDAI-Pruritus score was computed as the sum of 3 components ranging from 0 to 30. Higher scores indicated worse condition. Baseline was defined as the last recorded value on or prior to the date of randomization.
Outcome measures
| Measure |
DB Period: Benralizumab
n=14 Participants
Participants received benralizumab with an initial loading dose of 60 mg followed by a maintenance dose of 30 mg Q4W as a SC injection for 36 weeks.
|
DB Period: Placebo
n=12 Participants
Participants received volume-matched placebo as a SC injection on the same dosing schedule as benralizumab Q4W for 36 weeks.
|
|---|---|---|
|
Change From Baseline in BPDAI-Pruritus Score at Week 36
|
-5.57 Score on a scale
Standard Deviation 7.23
|
-16.58 Score on a scale
Standard Deviation 9.21
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 16Population: FAS included all randomized participants who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only participants who had the opportunity to reach Week 16 are included in the analysis.
The cumulative OCS exposure was estimated as the sum over the relevant 4-week periods from the MMRM model. Baseline was defined as the last recorded value on or prior to the date of randomization. Equivalents were prednisone equivalents (converted from mg).
Outcome measures
| Measure |
DB Period: Benralizumab
n=24 Participants
Participants received benralizumab with an initial loading dose of 60 mg followed by a maintenance dose of 30 mg Q4W as a SC injection for 36 weeks.
|
DB Period: Placebo
n=24 Participants
Participants received volume-matched placebo as a SC injection on the same dosing schedule as benralizumab Q4W for 36 weeks.
|
|---|---|---|
|
Cumulative OCS Exposure From Baseline to Week 16
|
46.90 mg/kg
Standard Deviation 27.19
|
42.15 mg/kg
Standard Deviation 33.33
|
Adverse Events
DB Period: Benralizumab
Serious events: 9 serious events
Other events: 22 other events
Deaths: 1 deaths
DB Period: Placebo
Serious events: 8 serious events
Other events: 23 other events
Deaths: 1 deaths
OLE Period: Benralizumab (DB)/Benralizumab (OLE)
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
OLE Period: Placebo (DB)/Benralizumab (OLE)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB Period: Benralizumab
n=34 participants at risk
Participants received benralizumab with an initial loading dose of 60 mg followed by a maintenance dose of 30 mg Q4W as a SC injection for 36 weeks.
|
DB Period: Placebo
n=33 participants at risk
Participants received volume-matched placebo as a SC injection on the same dosing schedule as benralizumab Q4W for 36 weeks.
|
OLE Period: Benralizumab (DB)/Benralizumab (OLE)
n=16 participants at risk
Participants who received benralizumab in DB period received benralizumab 30 mg Q4W in OLE period for at least 1 year.
|
OLE Period: Placebo (DB)/Benralizumab (OLE)
n=18 participants at risk
Participants who received matched placebo in DB period benralizumab 30 mg Q4W in OLE period for at least 1 year.
|
|---|---|---|---|---|
|
Infections and infestations
Bacterial infection
|
2.9%
1/34 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Covid-19
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Covid-19 pneumonia
|
2.9%
1/34 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Pneumonia
|
2.9%
1/34 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Sepsis
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
2.9%
1/34 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
2.9%
1/34 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.9%
1/34 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Metabolism and nutrition disorders
Gout
|
2.9%
1/34 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.9%
1/34 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Skin and subcutaneous tissue disorders
Henoch-schonlein purpura
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
11.8%
4/34 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Vascular disorders
Hypotension
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
Other adverse events
| Measure |
DB Period: Benralizumab
n=34 participants at risk
Participants received benralizumab with an initial loading dose of 60 mg followed by a maintenance dose of 30 mg Q4W as a SC injection for 36 weeks.
|
DB Period: Placebo
n=33 participants at risk
Participants received volume-matched placebo as a SC injection on the same dosing schedule as benralizumab Q4W for 36 weeks.
|
OLE Period: Benralizumab (DB)/Benralizumab (OLE)
n=16 participants at risk
Participants who received benralizumab in DB period received benralizumab 30 mg Q4W in OLE period for at least 1 year.
|
OLE Period: Placebo (DB)/Benralizumab (OLE)
n=18 participants at risk
Participants who received matched placebo in DB period benralizumab 30 mg Q4W in OLE period for at least 1 year.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
General disorders
Oedema peripheral
|
11.8%
4/34 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.1%
2/33 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
General disorders
Pyrexia
|
2.9%
1/34 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.1%
2/33 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Body tinea
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.1%
2/33 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Covid-19
|
17.6%
6/34 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
12.1%
4/33 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Herpes zoster
|
11.8%
4/34 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.1%
2/33 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
2/34 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Oral candidiasis
|
5.9%
2/34 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.1%
2/33 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.1%
2/33 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
9.1%
3/33 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.9%
2/34 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Investigations
Heart rate increased
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.1%
2/33 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Investigations
Weight increased
|
5.9%
2/34 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.1%
2/33 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.1%
2/33 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
2/34 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.1%
2/33 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Nervous system disorders
Headache
|
2.9%
1/34 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Psychiatric disorders
Delirium
|
2.9%
1/34 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.1%
2/33 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.1%
2/33 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.1%
2/33 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
1/34 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.1%
2/33 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
1/34 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Eye disorders
Cataract
|
2.9%
1/34 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.9%
2/34 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.2%
1/16 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
2.9%
1/34 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.1%
2/33 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.9%
2/34 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
3.0%
1/33 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Vascular disorders
Flushing
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Vascular disorders
Hypertension
|
8.8%
3/34 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.1%
2/33 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/34 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
1/34 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
6.1%
2/33 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).
The safety analysis set consists of all participants who had received at least 1 dose of IP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place