Trial Outcomes & Findings for Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis (NCT NCT03996369)

NCT ID: NCT03996369

Last Updated: 2022-12-21

Results Overview

Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to \[\>=\] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (\<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 354 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2022-12-21

Participant Flow

The study included a screening period (up to 28 days), a double-blind induction treatment period (12 weeks), and a 2-week and a 4-week follow-up period. The target population consisted of male or female participants aged between 16 and 80 years (inclusive), with moderately to severely active ulcerative colitis (UC).

During the screening period, participants were evaluated for study entry based on the inclusion and exclusion criteria. Screening procedures to evaluate participant eligibility for the study were to be conducted within 28 days prior to study intervention administration on Day 1.

Participant milestones

Measure	Etrasimod 2 mg Participants were administered one tablet of etrasimod 2 milligrams (mg) orally once daily (QD) for 12 weeks.	Placebo Participants were administered one tablet of placebo orally QD for 12 weeks.
Overall Study STARTED	238	116
Overall Study COMPLETED	213	103
Overall Study NOT COMPLETED	25	13

Reasons for withdrawal

Measure	Etrasimod 2 mg Participants were administered one tablet of etrasimod 2 milligrams (mg) orally once daily (QD) for 12 weeks.	Placebo Participants were administered one tablet of placebo orally QD for 12 weeks.
Overall Study Protocol deviation	1	1
Overall Study Physician Decision	4	2
Overall Study Participant decision	0	1
Overall Study Lack of Efficacy	4	0
Overall Study Adverse Event	9	0
Overall Study Withdrawal by Subject	6	8
Overall Study Didn't meet Inclusion/Exclusion criteria	1	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis

Baseline characteristics by cohort

Measure	Etrasimod 2 mg n=238 Participants Participants were administered one tablet of etrasimod 2 milligrams (mg) orally once daily (QD) for 12 weeks.	Placebo n=116 Participants Participants were administered one tablet of placebo orally QD for 12 weeks.	Total n=354 Participants Total of all reporting groups
Age, Continuous	40.3 Years STANDARD_DEVIATION 13.49 • n=5 Participants	40.4 Years STANDARD_DEVIATION 13.28 • n=7 Participants	40.4 Years STANDARD_DEVIATION 13.40 • n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants	43 Participants n=7 Participants	146 Participants n=5 Participants
Sex: Female, Male Male	135 Participants n=5 Participants	73 Participants n=7 Participants	208 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	226 Participants n=5 Participants	107 Participants n=7 Participants	333 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Asian	47 Participants n=5 Participants	25 Participants n=7 Participants	72 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	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	176 Participants n=5 Participants	88 Participants n=7 Participants	264 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Full Analysis Set Population (All randomized participants who received at least 1 dose of study intervention), with actual Baseline MMS 5 to 9. Only those participants with data available at the specified time points were analyzed.

Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to [>=] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.

Outcome measures

Measure	Etrasimod 2 mg n=222 Participants Participants were administered one tablet of etrasimod 2 milligrams (mg) orally once daily (QD) for 12 weeks.	Placebo n=112 Participants Participants were administered one tablet of placebo orally QD for 12 weeks.
Percentage of Participants Achieving Clinical Remission	24.8 Percentage of participants	15.2 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set Population with actual Baseline MMS 5 to 9. Only those participants with data available at the specified time points were analyzed.

Endoscopic improvement was defined as an ES <= 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease); higher score indicated more severe disease.

Outcome measures

Measure	Etrasimod 2 mg n=222 Participants Participants were administered one tablet of etrasimod 2 milligrams (mg) orally once daily (QD) for 12 weeks.	Placebo n=112 Participants Participants were administered one tablet of placebo orally QD for 12 weeks.
Percentage of Participants Achieving Endoscopic Improvement	30.6 Percentage of participants	18.8 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set Population with actual Baseline MMS 5 to 9. Only those participants with data available at the specified time points were analyzed.

Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a >= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.

Outcome measures

Measure	Etrasimod 2 mg n=222 Participants Participants were administered one tablet of etrasimod 2 milligrams (mg) orally once daily (QD) for 12 weeks.	Placebo n=112 Participants Participants were administered one tablet of placebo orally QD for 12 weeks.
Percentage of Participants Achieving Symptomatic Remission	46.8 Percentage of participants	29.5 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set Population with actual Baseline MMS 5 to 9. Only those participants with data available at the specified time points were analyzed.

Mucosal healing was defined as an ES <= 1 (excluding friability) with histologic remission measured by a Geboes Index score less than [<] 2.0). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease.

Outcome measures

Measure	Etrasimod 2 mg n=222 Participants Participants were administered one tablet of etrasimod 2 milligrams (mg) orally once daily (QD) for 12 weeks.	Placebo n=112 Participants Participants were administered one tablet of placebo orally QD for 12 weeks.
Percentage of Participants With Mucosal Healing	16.2 Percentage of participants	8.9 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set Population with actual Baseline MMS 5 to 9. Only those participants with data available at the specified time points were analyzed.

Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a >= 2-point and >= 30 percent (%) decrease from Baseline MMS, and a >= 1-point decrease from Baseline in RB sub-score or an absolute RB sub-score <= 1. Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.

Outcome measures

Measure	Etrasimod 2 mg n=222 Participants Participants were administered one tablet of etrasimod 2 milligrams (mg) orally once daily (QD) for 12 weeks.	Placebo n=112 Participants Participants were administered one tablet of placebo orally QD for 12 weeks.
Percentage of Participants Achieving Clinical Response	62.2 Percentage of participants	41.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set Population with actual Baseline MMS 5 to 9. Only those participants with data available at the specified time points were analyzed.

Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease); higher score indicated more severe disease.

Outcome measures

Measure	Etrasimod 2 mg n=222 Participants Participants were administered one tablet of etrasimod 2 milligrams (mg) orally once daily (QD) for 12 weeks.	Placebo n=112 Participants Participants were administered one tablet of placebo orally QD for 12 weeks.
Percentage of Participants Achieving Endoscopic Normalization	17.1 Percentage of participants	8.0 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4 and 8

Population: Full Analysis Set Population with actual Baseline MMS 5 to 9. Only those participants with data available at the specified time points were analyzed.

Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a >= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.

Outcome measures

Measure	Etrasimod 2 mg n=222 Participants Participants were administered one tablet of etrasimod 2 milligrams (mg) orally once daily (QD) for 12 weeks.	Placebo n=112 Participants Participants were administered one tablet of placebo orally QD for 12 weeks.
Percentage of Participants Achieving Symptomatic Remission at Weeks 2, 4 and 8 Week 2	16.2 Percentage of participants	10.7 Percentage of participants
Percentage of Participants Achieving Symptomatic Remission at Weeks 2, 4 and 8 Week 4	27.5 Percentage of participants	16.1 Percentage of participants
Percentage of Participants Achieving Symptomatic Remission at Weeks 2, 4 and 8 Week 8	38.7 Percentage of participants	24.1 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8 and 12

Population: Full Analysis Set Population with actual Baseline MMS 5 to 9. Only those participants with data available at the specified time points were analyzed.

Complete symptomatic remission was defined as an SF sub-score = 0 and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.

Outcome measures

Measure	Etrasimod 2 mg n=222 Participants Participants were administered one tablet of etrasimod 2 milligrams (mg) orally once daily (QD) for 12 weeks.	Placebo n=112 Participants Participants were administered one tablet of placebo orally QD for 12 weeks.
Percentage of Participants Achieving Complete Symptomatic Remission Week 2	4.5 Percentage of participants	1.8 Percentage of participants
Percentage of Participants Achieving Complete Symptomatic Remission Week 4	11.7 Percentage of participants	3.6 Percentage of participants
Percentage of Participants Achieving Complete Symptomatic Remission Week 8	14.0 Percentage of participants	7.1 Percentage of participants
Percentage of Participants Achieving Complete Symptomatic Remission Week 12	18.0 Percentage of participants	8.9 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8 and 12

Population: Full Analysis Set Population with actual Baseline MMS 5 to 9. Only those participants with data available at the specified time points were analyzed.

Non-invasive clinical response was defined as a >= 30% decrease from Baseline in composite RB and SF sub-scores, and a >= 1 point decrease from Baseline in RB sub-score or RB sub-score <= 1. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease.

Outcome measures

Measure	Etrasimod 2 mg n=222 Participants Participants were administered one tablet of etrasimod 2 milligrams (mg) orally once daily (QD) for 12 weeks.	Placebo n=112 Participants Participants were administered one tablet of placebo orally QD for 12 weeks.
Percentage of Participants Achieving Non-invasive Clinical Response Week 2	39.2 Percentage of participants	24.1 Percentage of participants
Percentage of Participants Achieving Non-invasive Clinical Response Week 4	55.9 Percentage of participants	41.1 Percentage of participants
Percentage of Participants Achieving Non-invasive Clinical Response Week 8	68.0 Percentage of participants	45.5 Percentage of participants
Percentage of Participants Achieving Non-invasive Clinical Response Week 12	67.6 Percentage of participants	50.0 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8 and 12

Population: Full Analysis Set Population with actual Baseline MMS 5 to 9. Only those participants with data available at the specified time points were analyzed.

Symptomatic response was defined as a >= 30% decrease from Baseline in composite RB and SF score. The SF sub-score ranged from 0 to 3 (where 0= normal number of stools and 3= at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0= no blood and 3= blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease.

Outcome measures

Measure	Etrasimod 2 mg n=222 Participants Participants were administered one tablet of etrasimod 2 milligrams (mg) orally once daily (QD) for 12 weeks.	Placebo n=112 Participants Participants were administered one tablet of placebo orally QD for 12 weeks.
Percentage of Participants Achieving Symptomatic Response Week 2	39.6 Percentage of participants	24.1 Percentage of participants
Percentage of Participants Achieving Symptomatic Response Week 4	56.3 Percentage of participants	41.1 Percentage of participants
Percentage of Participants Achieving Symptomatic Response Week 8	68.5 Percentage of participants	46.4 Percentage of participants
Percentage of Participants Achieving Symptomatic Response Week 12	68.5 Percentage of participants	50.0 Percentage of participants

Adverse Events

Etrasimod 2 mg

Serious events: 6 serious events

Other events: 112 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Measure	Etrasimod 2 mg n=238 participants at risk Participants were administered one tablet of etrasimod 2 milligrams (mg) orally once daily (QD) for 12 weeks.	Placebo n=116 participants at risk Participants were administered one tablet of placebo orally QD for 12 weeks.
Gastrointestinal disorders Colitis ulcerative	1.3% 3/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Cardiac disorders Coronary artery disease	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Injury, poisoning and procedural complications Hepatobiliary procedural complication	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Nervous system disorders Migraine	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Anaemia	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.

Other adverse events

Measure	Etrasimod 2 mg n=238 participants at risk Participants were administered one tablet of etrasimod 2 milligrams (mg) orally once daily (QD) for 12 weeks.	Placebo n=116 participants at risk Participants were administered one tablet of placebo orally QD for 12 weeks.
Gastrointestinal disorders Nausea	4.2% 10/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	1.7% 2/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Colitis ulcerative	3.4% 8/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Vomiting	2.1% 5/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	1.7% 2/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal pain	1.3% 3/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	2.6% 3/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Diarrhoea	1.3% 3/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Flatulence	0.84% 2/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal tenderness	0.84% 2/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal pain lower	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal pain upper	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Anal eczema	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Frequent bowel movements	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Gingival bleeding	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Irritable bowel syndrome	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Toothache	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	1.7% 2/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Chronic gastritis	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Gastritis	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Gastrointestinal hypermotility	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Haemorrhoids	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Hyperaesthesia teeth	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Lip blister	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Stomatitis	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Urinary tract infection	1.7% 4/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations COVID-19	1.3% 3/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	2.6% 3/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Upper respiratory tract infection	0.84% 2/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Sinusitis	0.84% 2/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Nasopharyngitis	1.3% 3/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	1.7% 2/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Anal abscess	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Campylobacter infection	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Clostridium difficile colitis	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Clostridium difficile infection	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Cytomegalovirus infection	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Cystitis	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Conjunctivitis	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Gastroenteritis	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Genitourinary tract infection	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Hordeolum	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Infected dermal cyst	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Influenza	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Localised infection	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Rhinitis	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Oral herpes	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Herpes zoster	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	1.7% 2/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Enterocolitis bacterial	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Laryngitis	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Rash pustular	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Tooth infection	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Viral infection	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Gamma-glutamyltransferase increased	2.1% 5/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Alanine aminotransferase increased	1.3% 3/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Blood creatine phosphokinase increased	1.3% 3/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Blood alkaline phosphatase increased	0.84% 2/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Aspartate aminotransferase increased	0.84% 2/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Activated partial thromboplastin time prolonged	0.84% 2/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Blood bilirubin increased	0.84% 2/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Blood cholesterol increased	0.84% 2/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Blood triglycerides increased	0.84% 2/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Weight decreased	0.84% 2/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Blood glucose increased	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Blood pressure increased	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Blood thyroid stimulating hormone increased	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Blood thyroid stimulating hormone decreased	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Heart rate increased	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Heart rate decreased	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Hepatic enzyme increased	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Prothrombin time prolonged	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Liver function test abnormal	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations International normalised ratio increased	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Pulmonary function test decreased	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Transaminases increased	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Blood creatinine increased	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations FEV1/FVC ratio decreased	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Lipase increased	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Lung diffusion test decreased	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	1.7% 2/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Nervous system disorders Headache	4.6% 11/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	1.7% 2/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Platelet count increased	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Nervous system disorders Somnolence	1.3% 3/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Nervous system disorders Dizziness	1.3% 3/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Nervous system disorders Dizziness postural	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Nervous system disorders Drug withdrawal headache	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Nervous system disorders Migraine	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	3.4% 4/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Nervous system disorders Sinus headache	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Nervous system disorders Presyncope	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Anaemia	5.9% 14/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	6.9% 8/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Iron deficiency anaemia	1.3% 3/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	2.6% 3/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Blood loss anaemia	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Microcytic anaemia	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Thrombocytosis	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
General disorders Fatigue	1.3% 3/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
General disorders Pyrexia	3.4% 8/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	2.6% 3/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
General disorders Chest discomfort	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
General disorders Feeling abnormal	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
General disorders Injection site reaction	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
General disorders Malaise	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
General disorders Non-cardiac chest pain	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
General disorders Thirst	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
General disorders Asthenia	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
General disorders Vaccination site pain	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
General disorders Oedema peripheral	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
General disorders Oedema	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Arthritis	0.84% 2/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Back pain	1.7% 4/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Muscular weakness	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Arthralgia	1.7% 4/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	2.6% 3/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Myalgia	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Pain in extremity	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Spinal pain	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypophosphataemia	1.7% 4/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Iron deficiency	1.3% 3/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypercholesterolaemia	0.84% 2/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Folate deficiency	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Gout	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hyperkalaemia	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypoalbuminaemia	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypomagnesaemia	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypokalaemia	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypoproteinaemia	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypovolaemia	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Underweight	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Increased appetite	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Vitamin D deficiency	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Eye disorders Uveitis	0.84% 2/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Eye disorders Vision blurred	0.84% 2/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Eye disorders Blepharitis	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Eye disorders Conjunctival haemorrhage	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Eye disorders Eye pain	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Eye disorders Conjunctivitis allergic	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Eye disorders Eyelid margin crusting	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Eye disorders Glaucoma	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Eye disorders Meibomian gland dysfunction	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Eye disorders Macular oedema	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Eye disorders Macular hole	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Eye disorders Visual impairment	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Eye disorders Pigment dispersion syndrome	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Eye disorders Metamorphopsia	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Eye disorders Visual snow syndrome	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Eye disorders Chorioretinopathy	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Eye disorders Exudative retinopathy	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Eye disorders Ocular hypertension	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Cardiac disorders Sinus bradycardia	1.7% 4/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Cardiac disorders Tachycardia	0.84% 2/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	1.7% 2/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Cardiac disorders Atrioventricular block first degree	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Cardiac disorders Bradycardia	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Cardiac disorders Sinus tachycardia	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Cardiac disorders Sinus arrhythmia	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Cardiac disorders Palpitations	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Cardiac disorders Ventricular extrasystoles	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Rash	0.84% 2/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Alopecia	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Cutaneous vasculitis	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Dermatitis contact	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Dry skin	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Night sweats	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Nail bed bleeding	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Miliaria	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Pruritus	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Hepatobiliary disorders Liver disorder	1.3% 3/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Blister	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Hepatobiliary disorders Hepatic function abnormal	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Hepatobiliary disorders Hepatic cytolysis	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Hepatobiliary disorders Cholestasis	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Vascular disorders Hypertension	1.3% 3/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Vascular disorders Venous thrombosis	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Vascular disorders Essential hypertension	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Injury, poisoning and procedural complications Fall	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Injury, poisoning and procedural complications Vaccination complication	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Injury, poisoning and procedural complications Wound complication	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Injury, poisoning and procedural complications Contusion	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.84% 2/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Cough	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Ear and labyrinth disorders Ear pain	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Ear and labyrinth disorders Tinnitus	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Renal and urinary disorders Haematuria	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Reproductive system and breast disorders Testicular torsion	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Renal and urinary disorders Nephrolithiasis	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Reproductive system and breast disorders Vaginal haemorrhage	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Endocrine disorders Hyperthyroidism	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Immune system disorders Food allergy	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papilloma	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Psychiatric disorders Initial insomnia	0.42% 1/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal distension	2.1% 5/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Dyspepsia	0.00% 0/238 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.86% 1/116 • All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention. Safety set population included all randomized participants who received at least 1 dose of study intervention.

Additional Information

Arena CT.gov Administrator

Arena Pharmaceuticals, Inc.

Phone: +1 855-218-9153

Email: ct.gov@arenapharm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place