Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome (NCT NCT04752566)

Last Updated: 2025-09-08

Results Overview

The mobility of the participants was evaluated on a 7 point disability functional grade scale and described as Hughes FG score of 0 (Healthy, no signs or symptoms of Guillain-Barré syndrome); 1 (Minor signs or symptoms and able to run); 2 (Able to walk 5 metre (m) across an open space without assistance); 3 (Able to walk 5 m across an open space with the help of one person and waist-level walking-frame, stick, or sticks); 4 (Chairbound/bedbound: unable to walk as in 3); 5 (Requiring assisted ventilation \[for at least part of day or night\]) and 6 (Dead), where higher numbers indicate more severe impairment. The Kaplan-Meier estimate of time to event of FG\<=1 is reported. Time (days) to first event=Date of first event-Date of first dose+1. Participants who discontinued early without achieving FG \<= 1 were censored at the date of discontinuation. Participants who completed the study without achieving FG\<=1 were censored at the date of study completion.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

57 participants

Primary outcome timeframe

Up to Week 24

Results posted on

2025-09-08

Participant Flow

All participants were on concomitant intravenous immunoglobulin (IVIg) therapy as per standard of care.

Participant milestones

Participant milestones
Measure	Eculizumab Participants received eculizumab intravenous (IV) infusion on Days 1, 8, 15, and 22.	Placebo Participants received placebo matched to eculizumab via IV infusion on Days 1, 8, 15, and 22.
Overall Study STARTED	37	20
Overall Study Received at Least 1 Dose of Study Drug	37	20
Overall Study COMPLETED	32	18
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Eculizumab Participants received eculizumab intravenous (IV) infusion on Days 1, 8, 15, and 22.	Placebo Participants received placebo matched to eculizumab via IV infusion on Days 1, 8, 15, and 22.
Overall Study Protocol Violation	0	1
Overall Study Death	1	0
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	2	0
Overall Study Physician Decision	1	1

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eculizumab n=37 Participants Participants received eculizumab IV infusion on Days 1, 8, 15, and 22.	Placebo n=20 Participants Participants received placebo matched to eculizumab via IV infusion on Days 1, 8, 15, and 22.	Total n=57 Participants Total of all reporting groups
Age, Continuous	56.6 years STANDARD_DEVIATION 19.61 • n=5 Participants	56.2 years STANDARD_DEVIATION 18.34 • n=7 Participants	56.4 years STANDARD_DEVIATION 19.01 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	5 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants	20 Participants n=7 Participants	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	37 Participants n=5 Participants	20 Participants n=7 Participants	57 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Week 24

Population: Full analysis set included all randomized participants who received at least 1 dose of study drug and had a baseline FG score and at least 1 postbaseline FG score. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Eculizumab n=20 Participants Participants received eculizumab IV infusion on Days 1, 8, 15, and 22.	Placebo n=13 Participants Participants received placebo matched to eculizumab via IV infusion on Days 1, 8, 15, and 22.
Time to First Reaching a Hughes Functional Grade (FG) Score <=1	112.0 Days Interval 59.0 to NA signifies upper limit was not estimable as study does not have enough events to estimate the median time to event.	168.0 Days Interval 36.0 to NA signifies upper limit was not estimable as study does not have enough events to estimate the median time to event.

SECONDARY outcome

Timeframe: Week 8, Week 24

Population: Full analysis set included all randomized participants who received at least 1 dose of study drug and had a baseline FG score and at least 1 postbaseline FG score.

The mobility of the participants was evaluated on a 7 point disability FG scale and described as Hughes FG score of 0 (Healthy, no signs or symptoms of Guillain-Barré syndrome); 1 (Minor signs or symptoms and able to run); 2 (Able to walk 5 m across an open space without assistance); 3 (Able to walk 5 m across an open space with the help of one person and waist-level walking-frame, stick, or sticks); 4 (Chairbound/bedbound: unable to walk as in 3); 5 (Requiring assisted ventilation \[for at least part of day or night\]) and 6 (Dead), where higher numbers indicate more severe impairment. If a participant had an FG score \<= 1 prior to or at Week 8 and Week 24, respectively, then the participant is considered a responder. Otherwise, participants discontinued prior to Week 8 and Week 24 or with an FG score \> 1 at Week 8 and Week 24 are nonresponders, respectively.

Outcome measures

Outcome measures
Measure	Eculizumab n=37 Participants Participants received eculizumab IV infusion on Days 1, 8, 15, and 22.	Placebo n=20 Participants Participants received placebo matched to eculizumab via IV infusion on Days 1, 8, 15, and 22.
Number of Participants With A Hughes Functional Grade (FG) Score <=1 Week 24	20 Participants	13 Participants
Number of Participants With A Hughes Functional Grade (FG) Score <=1 Week 8	12 Participants	7 Participants

SECONDARY outcome

Timeframe: Week 24

Population: Full analysis set included all randomized participants who received at least 1 dose of study drug and had a baseline FG score and at least 1 postbaseline FG score.

The mobility of the participants was evaluated on a 7 point disability FG scale and described as Hughes FG score of 0 (Healthy, no signs or symptoms of Guillain-Barré syndrome); 1 (Minor signs or symptoms and able to run); 2 (Able to walk 5 m across an open space without assistance); 3 (Able to walk 5 m across an open space with the help of one person and waist-level walking-frame, stick, or sticks); 4 (Chairbound/bedbound: unable to walk as in 3); 5 (Requiring assisted ventilation \[for at least part of day or night\]) and 6 (Dead), where higher numbers indicate more severe impairment. Participants with a change from baseline in FG score (value at Week 24 - baseline value) \<= -3 were considered a responder. Participants with change from baseline \> -3 and participants who discontinued prior to Week 24 were considered non-responders.

Outcome measures

Outcome measures
Measure	Eculizumab n=37 Participants Participants received eculizumab IV infusion on Days 1, 8, 15, and 22.	Placebo n=20 Participants Participants received placebo matched to eculizumab via IV infusion on Days 1, 8, 15, and 22.
Number of Participants With A Hughes Functional Grade Score Improvement of >=3	16 Participants	10 Participants

SECONDARY outcome

Timeframe: Day 1 up to Week 24

Population: Safety set included all participants who received at least 1 dose of study drug.

TEAEs were defined as an adverse event (AE) with onset on or after the first dose of the study drug. An AE is any untoward medical occurrence in a participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Outcome measures

Outcome measures
Measure	Eculizumab n=37 Participants Participants received eculizumab IV infusion on Days 1, 8, 15, and 22.	Placebo n=20 Participants Participants received placebo matched to eculizumab via IV infusion on Days 1, 8, 15, and 22.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	34 Participants	19 Participants

SECONDARY outcome

Timeframe: Week 24

Population: Pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of study drug and who have at least 1 postdose PD sample. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Eculizumab n=32 Participants Participants received eculizumab IV infusion on Days 1, 8, 15, and 22.	Placebo n=18 Participants Participants received placebo matched to eculizumab via IV infusion on Days 1, 8, 15, and 22.
Free Complement Component 5 in Serum	131.0438 micrograms/milliliters Standard Deviation 29.40068	147.8833 micrograms/milliliters Standard Deviation 36.70182

SECONDARY outcome

Timeframe: Week 24

Population: Pharmacodynamic analysis set included all participants who received at least 1 dose of study drug and who have at least 1 postdose PD sample. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Eculizumab n=32 Participants Participants received eculizumab IV infusion on Days 1, 8, 15, and 22.	Placebo n=18 Participants Participants received placebo matched to eculizumab via IV infusion on Days 1, 8, 15, and 22.
Hemolytic Complement Activity in Serum	91.79 percentage of hemolysis Standard Deviation 11.077	91.83 percentage of hemolysis Standard Deviation 11.767

SECONDARY outcome

Timeframe: Up to Week 24

Population: Full analysis set included all randomized participants who received at least 1 dose of study drug and had a baseline FG score and at least 1 postbaseline FG score.

For participants with multiple hospitalizations, the total duration of all hospitalizations was summarized.

Outcome measures

Outcome measures
Measure	Eculizumab n=37 Participants Participants received eculizumab IV infusion on Days 1, 8, 15, and 22.	Placebo n=20 Participants Participants received placebo matched to eculizumab via IV infusion on Days 1, 8, 15, and 22.
Length of Stay in the Hospital	49.5 days Standard Deviation 27.15	39.8 days Standard Deviation 12.97

SECONDARY outcome

Timeframe: Up to Week 24

Population: Full analysis set included all randomized participants who received at least 1 dose of study drug and had a baseline FG score and at least 1 postbaseline FG score.

For participants with more than 1 episode of the same support, the total duration across all episodes was summarized.

Outcome measures

Outcome measures
Measure	Eculizumab n=37 Participants Participants received eculizumab IV infusion on Days 1, 8, 15, and 22.	Placebo n=20 Participants Participants received placebo matched to eculizumab via IV infusion on Days 1, 8, 15, and 22.
Number of Participants Who Required Mechanical Ventilator Support	8 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Week 24

Population: Pharmacokinetic analysis set (PKAS) included all participants who received at least 1 dose of study drug and who had at least 1 postdose PK sample. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Eculizumab n=32 Participants Participants received eculizumab IV infusion on Days 1, 8, 15, and 22.	Placebo Participants received placebo matched to eculizumab via IV infusion on Days 1, 8, 15, and 22.
Concentration of Eculizumab in Serum	4.690 micrograms/milliliters Standard Deviation 0.0000	—

SECONDARY outcome

Timeframe: Up to Week 12

Population: Safety set included all participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Eculizumab n=37 Participants Participants received eculizumab IV infusion on Days 1, 8, 15, and 22.	Placebo n=20 Participants Participants received placebo matched to eculizumab via IV infusion on Days 1, 8, 15, and 22.
Number of Participants With Positive Antidrug Antibodies	0 Participants	0 Participants

Adverse Events

Eculizumab

Serious events: 4 serious events

Other events: 34 other events

Deaths: 1 deaths

Placebo

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Eculizumab n=37 participants at risk Participants received eculizumab IV infusion on Days 1, 8, 15, and 22.	Placebo n=20 participants at risk Participants received placebo matched to eculizumab via IV infusion on Days 1, 8, 15, and 22.
General disorders Hanging	2.7% 1/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	0.00% 0/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia aspiration	5.4% 2/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	0.00% 0/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Infections and infestations COVID-19	2.7% 1/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	0.00% 0/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Nervous system disorders Chronic inflammatory demyelinating polyradiculoneuropathy	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.

Other adverse events

Additional Information

Alexion Pharmaceuticals Inc.

Phone: +1 855-752-2356

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Eculizumab n=37 participants at risk Participants received eculizumab IV infusion on Days 1, 8, 15, and 22.	Placebo n=20 participants at risk Participants received placebo matched to eculizumab via IV infusion on Days 1, 8, 15, and 22.
Blood and lymphatic system disorders Anaemia	10.8% 4/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	0.00% 0/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Leukopenia	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Cardiac disorders Bradycardia	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Eye disorders Dry eye	5.4% 2/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	0.00% 0/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	10.8% 4/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	35.0% 7/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	13.5% 5/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Stomatitis	5.4% 2/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal distension	5.4% 2/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	0.00% 0/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastritis	5.4% 2/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	0.00% 0/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	5.4% 2/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	0.00% 0/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
General disorders Pyrexia	13.5% 5/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	0.00% 0/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
General disorders Oedema	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
General disorders Pain	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Hepatobiliary disorders Hepatic function abnormal	10.8% 4/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	10.0% 2/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Hepatobiliary disorders Drug-induced liver injury	8.1% 3/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	0.00% 0/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Hepatobiliary disorders Liver disorder	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Immune system disorders Hypersensitivity	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	13.5% 5/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	15.0% 3/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia aspiration	13.5% 5/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	10.0% 2/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Infections and infestations COVID-19	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Infections and infestations Conjunctivitis	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Infections and infestations Genital candidiasis	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Investigations Aspartate aminotransferase increased	5.4% 2/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	15.0% 3/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Investigations Alanine aminotransferase increased	2.7% 1/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	15.0% 3/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Investigations Liver function test increased	2.7% 1/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	10.0% 2/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Investigations Neutrophil count decreased	5.4% 2/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	0.00% 0/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Investigations Blood creatine phosphokinase increased	2.7% 1/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Investigations Blood lactate dehydrogenase increased	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Investigations C-reactive protein increased	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Investigations Fibrin D dimer increased	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Investigations Gamma-glutamyltransferase increased	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Investigations Protein urine	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	13.5% 5/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	15.0% 3/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	5.4% 2/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	0.00% 0/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Dehydration	2.7% 1/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	5.4% 2/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	8.1% 3/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	0.00% 0/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	5.4% 2/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	0.00% 0/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Nervous system disorders Headache	13.5% 5/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	15.0% 3/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Nervous system disorders Neuropathy peripheral	2.7% 1/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Nervous system disorders Facial paralysis	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Nervous system disorders Lumbar radiculopathy	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Nervous system disorders Restless legs syndrome	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Insomnia	27.0% 10/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	40.0% 8/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Delirium	5.4% 2/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	0.00% 0/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Dysuria	2.7% 1/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Haematuria	5.4% 2/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	0.00% 0/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Renal impairment	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Genital rash	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Sputum retention	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis contact	8.1% 3/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	15.0% 3/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash	10.8% 4/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Dry skin	10.8% 4/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	0.00% 0/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Eczema	5.4% 2/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis diaper	2.7% 1/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin erosion	2.7% 1/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Asteatosis	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Eczema asteatotic	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Vascular disorders Deep vein thrombosis	10.8% 4/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Vascular disorders Venous thrombosis limb	2.7% 1/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.
Vascular disorders Hypotension	0.00% 0/37 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.	5.0% 1/20 • Day 1 up to Week 24 Safety set included all participants who received at least 1 dose of study drug.