Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Alglucosidase Alfa Produced at the 4000 L Scale for Pompe Disease (NCT NCT01526785)

NCT ID: NCT01526785

Last Updated: 2015-12-08

Results Overview

Clinical stability was defined as absence of death due to disease progression or new dependency on invasive ventilation and; decline in cardiac status, motor function, and pulmonary function from baseline.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 113 participants
• Primary outcome timeframe: Week 52
• Results posted on: 2015-12-08

Participant Flow

The study was conducted in the United States. A total of 113 participants were treated between 9 March 2012 and 4 June 2014.

Participant milestones

Measure	Alglucosidase Alfa Alglucosidase alfa (4000 litre \[L\] scale) intravenous (IV) infusion administered for 52 weeks as per physician's routine practice.
Overall Study STARTED	113
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Measure	Alglucosidase Alfa Alglucosidase alfa (4000 litre \[L\] scale) intravenous (IV) infusion administered for 52 weeks as per physician's routine practice.
Overall Study Study Terminated by Sponsor	8
Overall Study Death	2
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Alglucosidase Alfa Produced at the 4000 L Scale for Pompe Disease

Baseline characteristics by cohort

Measure	Alglucosidase Alfa n=113 Participants Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
Age, Continuous	4.8 years STANDARD_DEVIATION 3.73 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 52

Population: Full analysis population. Number of participants analyzed = participants with available data at Week 52 for this outcome.

Clinical stability was defined as absence of death due to disease progression or new dependency on invasive ventilation and; decline in cardiac status, motor function, and pulmonary function from baseline.

Outcome measures

Measure	Alglucosidase Alfa n=104 Participants Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
Percentage of Participants Who Were Clinically Stable or Improved at Week 52	83.7 percentage of participants Interval 75.1 to 90.2

SECONDARY outcome

Timeframe: Week 52

Population: Full analysis population.

Percentage of participants who were alive at Week 52, were reported. Survival rate was calculated by Kaplan-Meier estimate.

Outcome measures

Measure	Alglucosidase Alfa n=113 Participants Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
Survival Rate at Week 52	98.1 percentage of participants Interval 92.73 to 99.53

SECONDARY outcome

Timeframe: Week 52

Population: Full analysis population. Number of participants analyzed = participants with available data at Week 52 for this outcome.

Percentage of participants, who were invasive ventilator-free at week 52, are reported. Invasive ventilation was defined as mechanical ventilatory support applied with the use of an endotracheal tube or tracheostomy. Invasive ventilator-free survival rate was calculated by Kaplan-Meier estimate.

Outcome measures

Measure	Alglucosidase Alfa n=81 Participants Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
Invasive Ventilator-Free Survival Rate at Week 52	92.4 percentage of participants Interval 83.89 to 96.53

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Full analysis population. Number of participants analyzed = participants with available data at Week 52 for this outcome.

Z-Scores indicate the number of standard deviations (SD) from the mean in a normal distribution. A negative change from baseline indicates an increase in LVM-Z score. The normal range is -2 to 2 and greater than 2 may indicate left ventricular hypertrophy.

Outcome measures

Measure	Alglucosidase Alfa n=67 Participants Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
Change From Baseline on Left Ventricular Mass Z-Score (LVM-Z) at Week 52	-0.5 Z score Standard Deviation 1.71

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Full analysis population. Number of participants analysed = participants with baseline and Week 52 GMFM-88 data.

GMFM-88 (88-item measure to detect gross motor function) consists of 5 components, each measured on a 4-point Likert scale.The score for each dimension was expressed as a percentage of the maximum score for that dimension.Total score ranges from 0% to 100%, where higher scores indicate better motor functions.

Outcome measures

Measure	Alglucosidase Alfa n=90 Participants Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
Change From Baseline on Gross Motor Function Measure-88 (GMFM-88) at Week 52	3.7 percentage of total score Standard Deviation 17.46

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Full analysis population. Number of participants analysed = participants with baseline and Week 52 FVC data.

Percent predicted FVC values are reported. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%.

Outcome measures

Measure	Alglucosidase Alfa n=13 Participants Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
Change From Baseline in Forced Vital Capacity (FVC) at Week 52- At Supine Position	3.2 percent predicted FVC Standard Deviation 11.07

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Full analysis population. Number of participants analysed = participants with baseline and Week 52 FVC data.

Percent predicted FVC values are reported. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%.

Outcome measures

Measure	Alglucosidase Alfa n=22 Participants Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
Change From Baseline in Forced Vital Capacity (FVC) at Week 52- At Sitting Position	2.3 percent predicted FVC Standard Deviation 11.8

Adverse Events

Alglucosidase Alfa

Serious events: 73 serious events

Other events: 113 other events

Deaths: 0 deaths

Serious adverse events

Measure	Alglucosidase Alfa n=113 participants at risk Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per participant's routine practice.
Cardiac disorders Bradycardia	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Cardiac arrest	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Cardiac failure congestive	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Cardio-respiratory arrest	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Cardiopulmonary failure	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Cyanosis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Left ventricular hypertrophy	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Mitral valve incompetence	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Pulseless electrical activity	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Sinus tachycardia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Supraventricular tachycardia	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Tachycardia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Ear and labyrinth disorders Motion sickness	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Eye disorders Eyelid ptosis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Abdominal pain	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Constipation	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Dental caries	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Diarrhoea	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Dysphagia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Gastrointestinal disorder	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Intussusception	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Nausea	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Vomiting	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Chest pain	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Chills	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Device breakage	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Device malfunction	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Hypothermia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Oedema peripheral	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Pyrexia	8.8% 10/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Hepatobiliary disorders Cholecystitis acute	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Adenovirus infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Bacteraemia	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Bacterial tracheitis	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Bronchiolitis	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Cellulitis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Device related infection	5.3% 6/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Gastroenteritis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Gastroenteritis viral	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Haemophilus bacteraemia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Influenza	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Klebsiella bacteraemia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Lobar pneumonia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Lung infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Metapneumovirus infection	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Otitis media acute	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Parainfluenzae virus infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Periumbilical abscess	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Pneumonia	22.1% 25/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Pneumonia parainfluenzae viral	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Pneumonia pseudomonal	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Pneumonia respiratory syncytial viral	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Pneumonia viral	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Respiratory syncytial virus infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Respiratory tract infection	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Respiratory tract infection viral	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Rhinovirus infection	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Sepsis	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Staphylococcal infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Tracheitis	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Tracheostomy infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Upper respiratory tract infection	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Urinary tract infection	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Urinary tract infection bacterial	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Urinary tract infection staphylococcal	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Urosepsis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Viral infection	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Feeding tube complication	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Femur fracture	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Foreign body	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Foreign body aspiration	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Tracheal obstruction	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Traumatic haemothorax	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Alanine aminotransferase increased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Aspartate aminotransferase increased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Blood albumin decreased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Gamma-glutamyltransferase increased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Oxygen saturation decreased	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Metabolism and nutrition disorders Dehydration	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Metabolism and nutrition disorders Failure to thrive	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Metabolism and nutrition disorders Fluid overload	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Metabolism and nutrition disorders Hypoglycaemia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Muscle contracture	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Muscular weakness	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Brain injury	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Cerebral ischaemia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Convulsion	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Gross motor delay	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Loss of consciousness	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Presyncope	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Tremor	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Psychiatric disorders Mental status changes	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Psychiatric disorders Self-injurious ideation	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Renal and urinary disorders Urinary retention	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Apnoea	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Aspiration	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Atelectasis	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Bronchial secretion retention	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Cough	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Pulmonary granuloma	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Respiratory distress	14.2% 16/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Respiratory failure	6.2% 7/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Rhonchi	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Purpura	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Rash	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Surgical and medical procedures Central venous catheterisation	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Surgical and medical procedures Therapeutic procedure	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Vascular disorders Hypotension	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Vascular disorders Jugular vein thrombosis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.

Other adverse events

Measure	Alglucosidase Alfa n=113 participants at risk Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per participant's routine practice.
Cardiac disorders Right atrial dilatation	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Blood and lymphatic system disorders Anaemia	6.2% 7/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Blood and lymphatic system disorders Coagulopathy	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Blood and lymphatic system disorders Eosinophilia	5.3% 6/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Blood and lymphatic system disorders Iron deficiency anaemia	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Blood and lymphatic system disorders Lymphadenitis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Blood and lymphatic system disorders Lymphadenopathy	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Blood and lymphatic system disorders Neutropenia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Arrhythmia	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Bradycardia	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Bundle branch block right	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Cardiac failure	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Cardiomyopathy	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Defect conduction intraventricular	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Diastolic dysfunction	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Heart valve incompetence	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Left ventricular dysfunction	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Pericardial effusion	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Right ventricular hypertrophy	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Sinus bradycardia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Sinus tachycardia	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Supraventricular tachycardia	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Tachycardia	11.5% 13/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Tricuspid valve incompetence	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Cardiac disorders Wolff-Parkinson-White syndrome	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Congenital, familial and genetic disorders Cryptorchism	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Ear and labyrinth disorders Cerumen impaction	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Ear and labyrinth disorders Conductive deafness	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Ear and labyrinth disorders Deafness	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Ear and labyrinth disorders Deafness neurosensory	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Ear and labyrinth disorders Deafness unilateral	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Ear and labyrinth disorders Ear pain	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Ear and labyrinth disorders Eustachian tube dysfunction	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Ear and labyrinth disorders Middle ear effusion	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Ear and labyrinth disorders Mixed deafness	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Ear and labyrinth disorders Otorrhoea	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Ear and labyrinth disorders Tympanic membrane disorder	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Ear and labyrinth disorders Tympanic membrane perforation	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Endocrine disorders Precocious puberty	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Eye disorders Astigmatism	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Eye disorders Blepharitis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Eye disorders Chalazion	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Eye disorders Conjunctival hyperaemia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Eye disorders Dry eye	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Eye disorders Eye discharge	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Eye disorders Eye irritation	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Eye disorders Eye pruritus	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Eye disorders Eye swelling	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Eye disorders Eyelid oedema	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Eye disorders Eyelid ptosis	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Eye disorders Hypermetropia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Eye disorders Lid sulcus deepened	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Eye disorders Myopia	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Eye disorders Ocular hyperaemia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Eye disorders Photophobia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Eye disorders Strabismus	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Eye disorders Vision blurred	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Abdominal discomfort	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Abdominal distension	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Abdominal pain	8.8% 10/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Abdominal pain upper	9.7% 11/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Abnormal faeces	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Feeling hot	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Anal fissure	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Aphthous stomatitis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Constipation	17.7% 20/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Dental caries	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Dental discomfort	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Diarrhoea	48.7% 55/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Dysphagia	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Faecal incontinence	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Faeces discoloured	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Flatulence	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Frequent bowel movements	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Gastric ulcer	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Gastritis	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Gastrointestinal disorder	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Gastrooesophageal reflux disease	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Gingival bleeding	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Haematochezia	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Haemorrhoids	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Ileus	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Infrequent bowel movements	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Lip blister	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Lip ulceration	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Mouth ulceration	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Nausea	10.6% 12/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Oral disorder	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Rectal fissure	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Regurgitation	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Retained deciduous tooth	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Retching	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Salivary hypersecretion	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Sensitivity of teeth	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Teething	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Tongue spasm	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Tooth deposit	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Tooth impacted	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Toothache	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Gastrointestinal disorders Vomiting	37.2% 42/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Abasia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Asthenia	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Catheter site erythema	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Catheter site extravasation	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Catheter site haemorrhage	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Catheter site inflammation	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Catheter site oedema	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Catheter site pain	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Catheter site rash	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Catheter site related reaction	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Catheter site swelling	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Chest discomfort	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Chest pain	5.3% 6/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Chills	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Crepitations	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Device breakage	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Device dislocation	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Device issue	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Device malfunction	8.0% 9/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Device occlusion	11.5% 13/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Discomfort	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Disease progression	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Energy increased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Extravasation	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Fatigue	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Gait disturbance	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Granuloma	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Gravitational oedema	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Influenza like illness	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Infusion site extravasation	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Infusion site swelling	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Injection site extravasation	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Injection site swelling	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Malaise	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Oedema	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Oedema peripheral	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Pain	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Peripheral swelling	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Pyrexia	54.0% 61/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Secretion discharge	5.3% 6/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Thirst	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
General disorders Thrombosis in device	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Hepatobiliary disorders Cholelithiasis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Hepatobiliary disorders Hepatic fibrosis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Immune system disorders Drug hypersensitivity	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Immune system disorders Food allergy	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Immune system disorders Hypersensitivity	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Immune system disorders Multiple allergies	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Immune system disorders Seasonal allergy	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Abscess limb	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Acarodermatitis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Adenovirus infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Atypical pneumonia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Bacterial tracheitis	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Beta haemolytic streptococcal infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Body tinea	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Bronchiolitis	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Bronchitis	7.1% 8/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Candida infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Cellulitis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Chronic sinusitis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Clostridium difficile colitis	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Conjunctivitis	6.2% 7/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Croup infectious	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Device related infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Ear infection	10.6% 12/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Ear lobe infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Enterovirus infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Erythema infectiosum	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Escherichia urinary tract infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Eye infection	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Folliculitis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Fungal infection	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Fungal skin infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Furuncle	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Gastroenteritis	9.7% 11/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Gastroenteritis norovirus	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Gastroenteritis viral	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Gastrointestinal infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Gingival abscess	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Gingivitis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Haemophilus infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Hand-foot-and-mouth disease	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Herpes zoster	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Hordeolum	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Impetigo	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Influenza	7.1% 8/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Labyrinthitis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Lice infestation	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Lip infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Lobar pneumonia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Nail infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Nasopharyngitis	10.6% 12/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Oral candidiasis	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Oral herpes	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Otitis externa	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Otitis externa fungal	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Otitis media	20.4% 23/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Otitis media acute	5.3% 6/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Otitis media chronic	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Pharyngitis	6.2% 7/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Pharyngitis streptococcal	11.5% 13/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Pneumonia	15.0% 17/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Animal bite	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Pneumonia viral	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Pseudomonas infection	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Rash pustular	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Respiratory syncytial virus infection	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Respiratory tract infection	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Rhinitis	5.3% 6/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Rhinovirus infection	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Rotavirus infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Sinusitis	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Skin infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Staphylococcal infection	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Stoma site infection	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Streptococcal infection	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Streptococcal urinary tract infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Subcutaneous abscess	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Tinea infection	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Tonsillitis	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Tooth abscess	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Tooth infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Tracheitis	6.2% 7/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Tracheobronchitis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Tracheostomy infection	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Upper respiratory tract infection	43.4% 49/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Upper respiratory tract infection bacterial	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Urinary tract infection	16.8% 19/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Viral infection	13.3% 15/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Viral rash	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Viral upper respiratory tract infection	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Infections and infestations Vulvovaginal mycotic infection	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Agitation postoperative	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Animal scratch	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Ankle fracture	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Arthropod bite	6.2% 7/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Arthropod sting	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Concussion	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Contusion	5.3% 6/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Exposure to communicable disease	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Eye contusion	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Eye injury	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Paralysis flaccid	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Face injury	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Fall	9.7% 11/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Feeding tube complication	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Femur fracture	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Foreign body	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Hand fracture	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Head injury	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Humerus fracture	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Joint dislocation	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Laceration	5.3% 6/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Laryngeal injury	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Ligament sprain	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Limb injury	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Lower limb fracture	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Overdose	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Periorbital haemorrhage	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Post procedural haemorrhage	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Postoperative fever	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Postoperative respiratory distress	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Procedural nausea	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Procedural pain	7.1% 8/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Procedural vomiting	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Scratch	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Skin abrasion	8.0% 9/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Skin wound	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Soft tissue injury	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Splinter	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Stoma site erythema	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Stoma site haemorrhage	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Stoma site irritation	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Stoma site rash	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Stoma site reaction	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Sunburn	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Thermal burn	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Tibia fracture	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Tooth avulsion	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Tooth fracture	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Tooth injury	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Tracheostomy malfunction	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Vaccination complication	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Wound	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Injury, poisoning and procedural complications Wound dehiscence	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Alanine aminotransferase abnormal	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Alanine aminotransferase increased	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Aspartate aminotransferase abnormal	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Aspartate aminotransferase increased	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Atrial pressure increased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Blood alkaline phosphatase increased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Blood creatine phosphokinase MB increased	6.2% 7/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Blood creatine phosphokinase abnormal	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Blood creatine phosphokinase increased	6.2% 7/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Blood culture positive	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Blood lactate dehydrogenase abnormal	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Blood lactate dehydrogenase increased	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Blood potassium decreased	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Blood pressure decreased	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Blood pressure increased	6.2% 7/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Blood pressure systolic increased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Blood uric acid decreased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Blood uric acid increased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Blood zinc decreased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Body temperature increased	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Brain natriuretic peptide increased	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Breath sounds abnormal	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Creatine urine increased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Creatinine urine increased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Electrocardiogram PR shortened	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Electrocardiogram QT prolonged	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Electrocardiogram ST segment elevation	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Electrocardiogram abnormal	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Eosinophil count increased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Gamma-glutamyltransferase increased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Haematocrit decreased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Haemoglobin decreased	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Heart rate increased	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Liver function test abnormal	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Neutrophil count abnormal	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Neutrophil count increased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Neutrophil percentage increased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Occult blood positive	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Oxygen saturation decreased	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Platelet count increased	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Protein urine	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Protein urine present	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Pulmonary function test decreased	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Pulse pressure abnormal	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Respiratory rate increased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Serum ferritin decreased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Specific gravity urine	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Sputum culture positive	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Staphylococcus test positive	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Tuberculin test positive	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Urine ketone body present	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Urine output decreased	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Weight decreased	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations Weight increased	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations White blood cell count abnormal	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Investigations White blood cell count increased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Metabolism and nutrition disorders Abnormal weight gain	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Metabolism and nutrition disorders Decreased appetite	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Metabolism and nutrition disorders Dehydration	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Metabolism and nutrition disorders Electrolyte imbalance	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Metabolism and nutrition disorders Failure to thrive	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Metabolism and nutrition disorders Hypoalbuminaemia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Metabolism and nutrition disorders Hypochloraemia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Metabolism and nutrition disorders Hypoglycaemia	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Metabolism and nutrition disorders Hypokalaemia	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Metabolism and nutrition disorders Iron deficiency	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Metabolism and nutrition disorders Vitamin D deficiency	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Arthralgia	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Arthropathy	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Axillary mass	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Back pain	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Deformity thorax	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Foot deformity	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Fracture pain	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Hip deformity	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Joint contracture	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Joint stiffness	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Joint swelling	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Kyphosis	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Limb discomfort	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Muscle contracture	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Muscle spasms	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Muscle tightness	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Muscular weakness	10.6% 12/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Myalgia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Myopathy	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Neck pain	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Osteopenia	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Pain in extremity	14.2% 16/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Pain in jaw	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Scoliosis	5.3% 6/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Tendinous contracture	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Tendon discomfort	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Musculoskeletal and connective tissue disorders Tendon disorder	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Allodynia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Areflexia	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Burning sensation	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Clumsiness	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Convulsion	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Dizziness	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Facial paresis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Formication	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Gross motor delay	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Headache	12.4% 14/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Hypoaesthesia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Hyporeflexia	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Hypotonia	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Lethargy	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Motor developmental delay	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Motor dysfunction	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Muscle contractions involuntary	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Nystagmus	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Paraesthesia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Poor quality sleep	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Presyncope	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Psychomotor hyperactivity	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Somnolence	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Speech disorder	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Nervous system disorders Tremor	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Psychiatric disorders Oppositional defiant disorder	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Psychiatric disorders Aggression	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Psychiatric disorders Agitation	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Psychiatric disorders Anxiety	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Psychiatric disorders Attention deficit/hyperactivity disorder	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Psychiatric disorders Bruxism	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Psychiatric disorders Insomnia	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Psychiatric disorders Irritability	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Psychiatric disorders Mental disorder	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Psychiatric disorders Mood swings	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Psychiatric disorders Sleep disorder	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Renal and urinary disorders Dysuria	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Renal and urinary disorders Haematuria	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Renal and urinary disorders Incontinence	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Renal and urinary disorders Nephrolithiasis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Renal and urinary disorders Pollakiuria	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Renal and urinary disorders Proteinuria	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Renal and urinary disorders Urinary hesitation	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Renal and urinary disorders Urinary incontinence	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Renal and urinary disorders Urinary retention	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Reproductive system and breast disorders Genital discomfort	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Reproductive system and breast disorders Vaginal prolapse	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Reproductive system and breast disorders Vulvovaginal disorder	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Reproductive system and breast disorders Vulvovaginal erythema	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Reproductive system and breast disorders Vulvovaginal pruritus	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Aspiration	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Atelectasis	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Bronchial secretion retention	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Bronchial wall thickening	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Bronchomalacia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Choking	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Cough	31.9% 36/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.3% 6/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Hypoventilation	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Increased bronchial secretion	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	6.2% 7/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Increased viscosity of bronchial secretion	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Nasal congestion	14.2% 16/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Nasal discharge discolouration	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	11.5% 13/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Productive cough	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Pulmonary artery dilatation	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Respiratory distress	7.1% 8/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Respiratory muscle weakness	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	6.2% 7/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Respiratory tract haemorrhage	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	21.2% 24/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Rhonchi	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Sinus congestion	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Sneezing	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Snoring	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Sputum discoloured	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Sputum increased	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Throat irritation	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Throat tightness	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Tracheal ulcer	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	7.1% 8/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Use of accessory respiratory muscles	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Respiratory, thoracic and mediastinal disorders Wheezing	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Acne	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Alopecia	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Blister	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Cold sweat	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Decubitus ulcer	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Dermatitis	2.7% 3/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Dermatitis contact	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Dermatitis diaper	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Dry skin	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Ecchymosis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Eczema	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Erythema	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Excessive granulation tissue	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Granuloma skin	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Ingrowing nail	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Ingrown hair	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Macule	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Mechanical urticaria	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Papule	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Petechiae	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Pruritus	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Pruritus generalised	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Rash	27.4% 31/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Rash erythematous	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Rash macular	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Rash pruritic	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Red man syndrome	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Skin disorder	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Skin exfoliation	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Skin irritation	3.5% 4/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Skin lesion	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Skin ulcer	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Swelling face	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Skin and subcutaneous tissue disorders Urticaria	8.0% 9/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Surgical and medical procedures Central venous catheterisation	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Surgical and medical procedures Ear tube removal	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Surgical and medical procedures Gastrostomy tube removal	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Vascular disorders Aortic dilatation	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Vascular disorders Flushing	6.2% 7/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Vascular disorders Haematoma	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Vascular disorders Hypertension	4.4% 5/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Vascular disorders Hypotension	1.8% 2/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Vascular disorders Pallor	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.
Vascular disorders Peripheral coldness	0.88% 1/113 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants.

Additional Information

Trial Transparency Team

Sanofi

Email: Contact-US@sanofi.com

Results disclosure agreements

• Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
• Publication restrictions are in place

Restriction type: OTHER