Trial Outcomes & Findings for Study of Dose Confirmation and Safety of Crizanlizumab in Pediatric Sickle Cell Disease Patients (NCT NCT03474965)

Last Updated: 2025-10-16

Results Overview

The area under the curve (AUC) from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1) following the first dose. AUCd15 was calculated based on serum concentrations of crizanlizumab.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

117 participants

Primary outcome timeframe

Day 1 to Day 15

Results posted on

2025-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Age 12 to <18 Years, 5 mg/kg Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg Age 2 to \<6 years, 8.5 mg/kg
Overall Study STARTED	50	13	40	14
Overall Study COMPLETED	33	10	29	11
Overall Study NOT COMPLETED	17	3	11	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Age 12 to <18 Years, 5 mg/kg Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg Age 2 to \<6 years, 8.5 mg/kg
Overall Study Pregnancy	1	0	0	0
Overall Study Lost to Follow-up	0	0	1	0
Overall Study Death	1	0	0	0
Overall Study Adverse Event	1	0	0	1
Overall Study Physician Decision	3	1	2	0
Overall Study Participant Decision	7	0	1	0
Overall Study Guardian Decision	4	2	7	2

Baseline Characteristics

Study of Dose Confirmation and Safety of Crizanlizumab in Pediatric Sickle Cell Disease Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Age 12 to <18 Years, 5 mg/kg n=50 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=13 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=40 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=14 Participants Age 2 to \<6 years, 8.5 mg/kg	Total n=117 Participants Total of all reporting groups
Age, Categorical <=18 years	50 Participants n=5 Participants	13 Participants n=7 Participants	40 Participants n=5 Participants	14 Participants n=4 Participants	117 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	15.00 Years STANDARD_DEVIATION 1.921 • n=5 Participants	8.87 Years STANDARD_DEVIATION 1.745 • n=7 Participants	9.29 Years STANDARD_DEVIATION 1.614 • n=5 Participants	4.81 Years STANDARD_DEVIATION 0.868 • n=4 Participants	11.15 Years STANDARD_DEVIATION 3.983 • n=21 Participants
Age, Customized 0 - <28 d	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Customized 28 d - <2 y	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Customized 2 y - <12 y	0 Participants n=5 Participants	13 Participants n=7 Participants	40 Participants n=5 Participants	14 Participants n=4 Participants	67 Participants n=21 Participants
Age, Customized 12 y - <18 y	50 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	50 Participants n=21 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants	5 Participants n=4 Participants	56 Participants n=21 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	8 Participants n=7 Participants	23 Participants n=5 Participants	9 Participants n=4 Participants	61 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	10 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	32 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants	8 Participants n=4 Participants	66 Participants n=21 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants	2 Participants n=4 Participants	30 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 15

Population: Pharmacokinetic analysis set 1 - for treated participants with a valid measurement without a protocol deviation with impact.

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=10 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=11 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=13 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=10 Participants Age 2 to \<6 years, 8.5 mg/kg
Pharmacokinetics (PK): AUCd15 of Crizanlizumab After First Dose - Part A	10500 hr*ug/mL Standard Deviation 2290	8180 hr*ug/mL Standard Deviation 1620	20600 hr*ug/mL Standard Deviation 4530	14400 hr*ug/mL Standard Deviation 3990

PRIMARY outcome

Timeframe: Week 15 - Steady state

Population: Pharmacokinetic analysis set 1 - for treated participants with a valid measurement without a protocol deviation with impact.

The AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1).

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=7 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=6 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=11 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=12 Participants Age 2 to \<6 years, 8.5 mg/kg
Pharmacokinetics (PK) - AUCtau for Serum Crizanlizumab After Multiple Doses - Part A - Steady State	15800 hr*ug/mL Standard Deviation 2080	14800 hr*ug/mL Standard Deviation 3770	35700 hr*ug/mL Standard Deviation 8100	22100 hr*ug/mL Standard Deviation 6200

PRIMARY outcome

Timeframe: Week 1 (after first dose) and Week 15 (steady state)

Population: Pharmacokinetic analysis set 1 - for treated participants with a valid measurement without a protocol deviation with impact.

The maximum (peak) observed, serum, drug concentration after single or multiple dose administration (mass x volume-1)

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=11 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=11 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=13 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=12 Participants Age 2 to \<6 years, 8.5 mg/kg
Pharmacokinetics (PK) - Cmax for Crizanlizumab After First Dose and Multiple Doses - Part A - Steady State PK Single Dose (Week 1) (n=11,11,13,10)	80.5 ug/mL Standard Deviation 17.7	65.9 ug/mL Standard Deviation 11.3	175 ug/mL Standard Deviation 36.0	110 ug/mL Standard Deviation 37.3
Pharmacokinetics (PK) - Cmax for Crizanlizumab After First Dose and Multiple Doses - Part A - Steady State PK Multiple Dose - Week 15 (Steady state) (n=7,8,12,12)	95.6 ug/mL Standard Deviation 26.6	77.5 ug/mL Standard Deviation 19.0	171 ug/mL Standard Deviation 35.3	111 ug/mL Standard Deviation 27.4

PRIMARY outcome

Timeframe: Day 1 to Day 15

Population: Pharmacodynamic analysis set 1 - for treated participants with a valid measurement above the limit of quantitation without a protocol deviation with impact and for measurements that were above the limit of quantitation. (Age 2 to \<6 years, 8.5 mg/kg has n = '0' since the values were below the limit of quantitation (BLQ).)

The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1) following the first dose. AUCd15 was calculated based on P-selectin inhibition curves.

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=11 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=12 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=13 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg Age 2 to \<6 years, 8.5 mg/kg
Pharmacodynamics (PD) - P-selectin Inhibition Parameters for Crizanlizumab After First Dose - Part A - AUCd15	33700 hr*{Percent} inhibition P-selectin Standard Deviation 2440	34400 hr*{Percent} inhibition P-selectin Standard Deviation 3660	33200 hr*{Percent} inhibition P-selectin Standard Deviation 3410	—

PRIMARY outcome

Timeframe: Week 15 - Steady state

Population: Pharmacokinetic analysis set 1 - for treated participants with a valid measurement without a protocol deviation with impact.

The AUC of %inhibition calculated to the end of a dosing interval (tau) after multiple dose. AUCtau was calculated based on P-selectin inhibition curves.

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=6 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=7 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=11 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=10 Participants Age 2 to \<6 years, 8.5 mg/kg
Pharmacodynamics (PD) - P-selectin Inhibition Parameters for Crizanlizumab - Part A - AUCtau After Multiple Dose - Steady State	66700 hr*{Percent} inhibition P-selectin Standard Deviation 9560	64800 hr*{Percent} inhibition P-selectin Standard Deviation 3550	68600 hr*{Percent} inhibition P-selectin Standard Deviation 9210	66300 hr*{Percent} inhibition P-selectin Standard Deviation 5710

PRIMARY outcome

Timeframe: Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.

Population: Safety analysis set - all treated participants

An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=50 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=13 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=40 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=14 Participants Age 2 to \<6 years, 8.5 mg/kg
Frequency of Any Adverse Events (AEs) as a Measure of Safety and Tolerability AEs leading to dose interruption/reduction	17 Participants	6 Participants	10 Participants	7 Participants
Frequency of Any Adverse Events (AEs) as a Measure of Safety and Tolerability Adverse events (AEs)	47 Participants	13 Participants	38 Participants	14 Participants
Frequency of Any Adverse Events (AEs) as a Measure of Safety and Tolerability AEs -Treatment-related	16 Participants	5 Participants	14 Participants	4 Participants
Frequency of Any Adverse Events (AEs) as a Measure of Safety and Tolerability Serious Adverse events (SAEs)	18 Participants	9 Participants	20 Participants	12 Participants
Frequency of Any Adverse Events (AEs) as a Measure of Safety and Tolerability SAEs -Treatment-related	1 Participants	1 Participants	2 Participants	1 Participants
Frequency of Any Adverse Events (AEs) as a Measure of Safety and Tolerability Fatal SAEs	1 Participants	0 Participants	0 Participants	0 Participants
Frequency of Any Adverse Events (AEs) as a Measure of Safety and Tolerability Fatal SAEs-Treatment-related	0 Participants	0 Participants	0 Participants	0 Participants
Frequency of Any Adverse Events (AEs) as a Measure of Safety and Tolerability AEs requiring additional therapy	45 Participants	13 Participants	37 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline, Year 1 and Year 2

Population: Full analysis set - for treated participants with a valid measurement without a protocol deviation with impact who had VOC events leading to healthcare visit in clinic/ER/hospital.

VOC is defined as pain crises as well as other complicated crises, such as acute chest syndrome (ACS), priapism, and hepatic or splenic sequestration. The baseline annualized rate of VOC was defined as the number of VOCs leading to healthcare visit occurring within the last 12 months prior to screening until first dose. This annualized rate of VOC was calculated by multiplying the number of VOCs by 365 and dividing by the number of days in the observation period. (Parts A and B)

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=50 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=13 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=40 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=14 Participants Age 2 to \<6 years, 8.5 mg/kg
Annualized Rate Vaso Occlusive Crisis (VOC) Events Leading to Healthcare Visit in Clinic / Emergency Room (ER) / Hospital Baseline annualized rate of VOC	3.00 VOC events per year Interval 1.0 to 26.0	1.00 VOC events per year Interval 0.0 to 6.0	2.00 VOC events per year Interval 1.0 to 13.0	1.00 VOC events per year Interval 1.0 to 5.0
Annualized Rate Vaso Occlusive Crisis (VOC) Events Leading to Healthcare Visit in Clinic / Emergency Room (ER) / Hospital Annualized rate of VOC on treatment (up to Year 2)	1.80 VOC events per year Interval 0.0 to 14.5	0.79 VOC events per year Interval 0.0 to 10.4	1.48 VOC events per year Interval 0.0 to 8.7	1.22 VOC events per year Interval 0.0 to 5.3
Annualized Rate Vaso Occlusive Crisis (VOC) Events Leading to Healthcare Visit in Clinic / Emergency Room (ER) / Hospital Annualized rate of VOC on treatment Year 1 (n=42,11,35,12)	2.00 VOC events per year Interval 0.0 to 14.0	0.00 VOC events per year Interval 0.0 to 4.0	1.00 VOC events per year Interval 0.0 to 6.0	0.00 VOC events per year Interval 0.0 to 3.0
Annualized Rate Vaso Occlusive Crisis (VOC) Events Leading to Healthcare Visit in Clinic / Emergency Room (ER) / Hospital Annualized rate of VOC on treatment Year 2 (n=32,10,27,10)	2.00 VOC events per year Interval 0.0 to 8.0	0.00 VOC events per year Interval 0.0 to 5.0	1.00 VOC events per year Interval 0.0 to 9.0	2.00 VOC events per year Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: Up to Year 2

Population: Full analysis set - for treated participants with a valid measurement without a protocol deviation with impact who had VOC events treated at home (based on documentation by health care provider following phone contact with the patient.

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=19 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=2 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=10 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=2 Participants Age 2 to \<6 years, 8.5 mg/kg
Annualized Rate Vaso Occlusive Crisis (VOC) Events Treated at Home (Based on Documentation by Health Care Provider Following Phone Contact With the Patient)	0.94 VOC events per year Interval 0.5 to 3.9	2.71 VOC events per year Interval 0.5 to 4.9	0.49 VOC events per year Interval 0.49 to 3.0	0.73 VOC events per year Interval 0.5 to 1.0

SECONDARY outcome

Timeframe: Up to Year 2

Population: Full analysis set - for treated participants with uncomplicated pain crisis without a protocol deviation with impact who had VOC events leading to healthcare visit - uncomplicated pain crisis.

VOC is defined as pain crises as well as other complicated crises, such as acute chest syndrome (ACS), priapism, and hepatic or splenic sequestration. This annualized rate of VOC was calculated by multiplying the number of VOCs by 365 and dividing by the number of days in the observation period. (Parts A and B) Uncomplicated pain crisis is defined as an acute episode of pain with no known cause for pain other than a vaso-occlusive event; and requiring treatment with a parenteral or oral opioids or other parenteral analgesic; but is NOT classified as an acute chest syndrome, hepatic sequestration, splenic sequestration or priapism. The end of an uncomplicated pain crisis will be considered the resolution of acute pain, such that residual pain (or absence of any pain) is considered to be chronic, and the current pain medication regimen is considered to be for this chronic pain.

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=50 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=12 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=38 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=14 Participants Age 2 to \<6 years, 8.5 mg/kg
Annualized Rate Vaso Occlusive Crisis (VOC) Events Leading to Healthcare Visit - Uncomplicated Pain Crisis	1.79 VOC events per year Interval 0.0 to 14.5	0.98 VOC events per year Interval 0.0 to 10.4	1.47 VOC events per year Interval 0.0 to 8.7	0.97 VOC events per year Interval 0.0 to 5.3

SECONDARY outcome

Timeframe: Up to Year 2

Population: Full analysis set - for treated participants with acute chest syndrome without a protocol deviation with impact who had VOC events leading to healthcare visit - acute chest syndrome.

VOC is defined as pain crises as well as other complicated crises, such as acute chest syndrome (ACS), priapism, and hepatic or splenic sequestration. This annualized rate of VOC was calculated by multiplying the number of VOCs by 365 and dividing by the number of days in the observation period. (Parts A and B) Acute Chest Syndrome (ACS) is defined on the basis of the finding of a new pulmonary infiltrate involving at least one complete lung segment that was consistent with alveolar consolidation, but excluding atelectasis (as indicated by chest X-ray). At least one of the following additional signs or symptoms needs to be present as well: chest pain, a temperature of more than 38.5°C, tachypnea, wheezing or cough. ACS will be considered resolved when the patient is no longer hospitalized (unless for reason other than the ACS episode) and none of the additional signs or symptoms above are present (unless for reason other than the ACS).

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=18 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=4 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=15 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=6 Participants Age 2 to \<6 years, 8.5 mg/kg
Annualized Rate Vaso Occlusive Crisis (VOC) Events Leading to Healthcare Visit - Acute Chest Syndrome	0.49 VOC events per year Interval 0.0 to 3.7	0.64 VOC events per year Interval 0.0 to 1.5	0.49 VOC events per year Interval 0.0 to 1.0	0.49 VOC events per year Interval 0.0 to 1.9

SECONDARY outcome

Timeframe: Up to Year 2

Population: Full analysis set - for treated participants with hepatic sequestration without a protocol deviation with impact who had VOC events treated at home (based on documentation by health care provider following phone contact with the patient) - hepatic sequestration. There were no observations which met this criteria.

VOC is defined as pain crises as well as other complicated crises, such as acute chest syndrome (ACS), priapism, and hepatic or splenic sequestration. This annualized rate of VOC was calculated by multiplying the number of VOCs by 365 and dividing by the number of days in the observation period. (Parts A and B) Hepatic sequestration is defined on the basis of findings of right upper quadrant pain, an enlarged liver, and an acute decrease in hemoglobin concentration (e.g. a decrease in hemoglobin of \~ 2 g/dL). Acute hepatic sequestration will be considered resolved when right upper quadrant pain has returned to baseline (pre-event) levels and hemoglobin has been stable for 24 hrs. There were no patients with VOC events of hepatic sequestration treated at home. Therefore, there were no observations which met the report criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Year 2

Population: Full analysis set - for treated participants with splenic sequestration with a valid measurement and without a protocol deviation with impact who had VOC events leading to healthcare visit - splenic sequestration. (No patients in the 4th group met this criteria.)

VOC is defined as pain crises as well as other complicated crises, such as acute chest syndrome (ACS), priapism, and hepatic or splenic sequestration. This annualized rate of VOC was calculated by multiplying the number of VOCs by 365 and dividing by the number of days in the observation period. (Parts A and B) Splenic sequestration if defined on the basis of findings of left upper quadrant pain, an enlarged spleen, and an acute decrease in hemoglobin concentration (e.g., a decrease in hemoglobin of \~ 2 g/dL). Acute splenic sequestration will be considered resolved when left upper quadrant pain has returned to baseline (pre-event) levels and hemoglobin has been stable for 24 hrs.

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=3 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=1 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=1 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg Age 2 to \<6 years, 8.5 mg/kg
Annualized Rate Vaso Occlusive Crisis (VOC) Events Leading to Healthcare Visit - Splenic Sequestration	0.00 VOC events per year Interval 0.0 to 0.5	0.00 VOC events per year Interval 0.0 to 0.0	0.00 VOC events per year Interval 0.0 to 0.0	—

SECONDARY outcome

Timeframe: Up to Year 2

Population: Full analysis set - for treated participants with priapism and with a valid measurement above the limit of quantitation without a protocol deviation with impact who had VOC events leading to healthcare visit - priapism. (No patients in the 1st and 4th group met this criteria.)

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=1 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=1 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg Age 2 to \<6 years, 8.5 mg/kg
Annualized Rate Vaso Occlusive Crisis (VOC) Events Leading to Healthcare Visit - Priapism	—	0.49 VOC events per year Interval 0.49 to 0.49	0.00 VOC events per year Interval 0.0 to 0.0	—

SECONDARY outcome

Timeframe: Up to Year 2

Population: Full analysis set - for treated participants with a valid measurement without a protocol deviation with impact who had hospitalizations and ER visits (VOC-related).

VOC is defined as pain crises as well as other complicated crises, such as acute chest syndrome (ACS), priapism, and hepatic or splenic sequestration. This rate was calculated by multiplying the number of hospitalizations and ER visits (VOC-related) by 365 and dividing by the number of days in the observation period. Units would be something like: hospitalizations and ER visits per year. (Parts A and B)

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=50 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=13 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=40 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=14 Participants Age 2 to \<6 years, 8.5 mg/kg
Annualized Rate of Hospitalizations and Emergency Room (ER) Visits (VOC-related) Annualized rate of hospitalizations and ER visits (up to Year 2)	1.78 hospitalizations and ER visits per year Interval 0.0 to 13.5	0.50 hospitalizations and ER visits per year Interval 0.0 to 10.4	1.01 hospitalizations and ER visits per year Interval 0.0 to 9.6	0.74 hospitalizations and ER visits per year Interval 0.0 to 5.3
Annualized Rate of Hospitalizations and Emergency Room (ER) Visits (VOC-related) Annualized rate of hospitalizations and ER visits Year 1 (n=42,11,35,12)	2.00 hospitalizations and ER visits per year Interval 0.0 to 14.0	0.00 hospitalizations and ER visits per year Interval 0.0 to 5.0	1.00 hospitalizations and ER visits per year Interval 0.0 to 6.0	0.00 hospitalizations and ER visits per year Interval 0.0 to 3.0
Annualized Rate of Hospitalizations and Emergency Room (ER) Visits (VOC-related) Annualized rate of hospitalizations and ER visits Year 2 (n=32,10,27,10)	2.00 hospitalizations and ER visits per year Interval 0.0 to 9.0	0.00 hospitalizations and ER visits per year Interval 0.0 to 5.0	1.00 hospitalizations and ER visits per year Interval 0.0 to 10.0	1.00 hospitalizations and ER visits per year Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: Up to Year 2

Population: Full analysis set - for treated participants with a valid measurement without a protocol deviation with impact who had hospitalizations and ER visits.

VOC is defined as pain crises as well as other complicated crises, such as acute chest syndrome (ACS), priapism, and hepatic or splenic sequestration. The baseline annualized rate of VOC was defined as the number of VOCs leading to healthcare visit occurring within the last 12 months prior to screening until first dose. This rate was calculated by multiplying the number of hospitalizations and ER visits (VOC-related) by 365 and dividing by the number of days in the observation period. Units would be something like: hospitalizations and ER visits per year. (Parts A and B)

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=50 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=13 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=40 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=14 Participants Age 2 to \<6 years, 8.5 mg/kg
Annualized Rate of Hospitalizations and Emergency Room (ER) Visits (Total) Annualized rate of hospitalizations and ER visits (up to Year 2)	2.68 hospitalizations and ER visits per year Interval 0.0 to 15.5	1.46 hospitalizations and ER visits per year Interval 0.0 to 11.4	1.59 hospitalizations and ER visits per year Interval 0.0 to 11.7	1.74 hospitalizations and ER visits per year Interval 0.0 to 7.7
Annualized Rate of Hospitalizations and Emergency Room (ER) Visits (Total) Annualized rate of hospitalizations and ER visits Year 1 (n=42,11,35,12)	2.00 hospitalizations and ER visits per year Interval 0.0 to 16.0	1.00 hospitalizations and ER visits per year Interval 0.0 to 5.0	2.00 hospitalizations and ER visits per year Interval 0.0 to 7.0	2.00 hospitalizations and ER visits per year Interval 0.0 to 8.0
Annualized Rate of Hospitalizations and Emergency Room (ER) Visits (Total) Annualized rate of hospitalizations and ER visits Year 2 (n=32,10,27,10)	2.50 hospitalizations and ER visits per year Interval 0.0 to 10.0	1.00 hospitalizations and ER visits per year Interval 0.0 to 8.0	1.00 hospitalizations and ER visits per year Interval 0.0 to 10.0	2.00 hospitalizations and ER visits per year Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: Years 1 and 2

Population: Full analysis set - for treated participants with a valid measurement without a protocol deviation with impact who had ER/hospitalizations.

VOC is defined as pain crises as well as other complicated crises, such as acute chest syndrome (ACS), priapism, and hepatic or splenic sequestration. The baseline annualized rate of VOC was defined as the number of VOCs leading to healthcare visit occurring within the last 12 months prior to screening until first dose. This rate was calculated by multiplying the number of days of ER/hospitalizations (both overall and VOC-related) by 365 and dividing by the number of days in the observation period. (Parts A and B)

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=50 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=13 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=40 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=14 Participants Age 2 to \<6 years, 8.5 mg/kg
Annualized Days of Emergency Room (ER) / Hospitalization (Both Overall and VOC-related) Annualized days of ER/Hospitalization on treatment - VOC related (up to Year 2)	6.74 Days per year Interval 0.0 to 87.0	0.98 Days per year Interval 0.0 to 59.2	5.36 Days per year Interval 0.0 to 40.0	2.20 Days per year Interval 0.0 to 42.7
Annualized Days of Emergency Room (ER) / Hospitalization (Both Overall and VOC-related) Annualized days of ER/Hospitalization on treatment - Total (up to Year 2)	12.37 Days per year Interval 0.0 to 87.0	5.41 Days per year Interval 0.0 to 59.2	9.03 Days per year Interval 0.0 to 57.5	10.48 Days per year Interval 0.0 to 42.7
Annualized Days of Emergency Room (ER) / Hospitalization (Both Overall and VOC-related) Annualized days of ER/Hospitalization Year 1 - VOC related (n=42,11,12, 12)	7.00 Days per year Interval 0.0 to 60.3	0.00 Days per year Interval 0.0 to 23.0	5.00 Days per year Interval 0.0 to 37.0	0.00 Days per year Interval 0.0 to 29.0
Annualized Days of Emergency Room (ER) / Hospitalization (Both Overall and VOC-related) Annualized days of ER/Hospitalization Year 1 - Total (n=42,11,12, 12)	7.00 Days per year Interval 0.0 to 60.3	2.00 Days per year Interval 0.0 to 24.0	11.00 Days per year Interval 0.0 to 37.0	6.50 Days per year Interval 0.0 to 34.0
Annualized Days of Emergency Room (ER) / Hospitalization (Both Overall and VOC-related) Annualized days of ER/Hospitalization Year 2 - VOC related (n=32,10,11, 10)	10.50 Days per year Interval 0.0 to 71.0	0.00 Days per year Interval 0.0 to 48.0	2.00 Days per year Interval 0.0 to 40.0	3.00 Days per year Interval 0.0 to 19.0
Annualized Days of Emergency Room (ER) / Hospitalization (Both Overall and VOC-related) Annualized days of ER/Hospitalization Year 2 - Total (n=32,10,11, 10)	13.00 Days per year Interval 0.0 to 71.0	2.00 Days per year Interval 0.0 to 64.0	3.00 Days per year Interval 0.0 to 40.0	10.50 Days per year Interval 0.0 to 37.0

SECONDARY outcome

Timeframe: On Treatment, up to Year 2

Population: Safety analysis set - all treated participants who had dactylitis events. There were no observations which met the report criteria.

Dactylitis, also known as 'hand-foot syndrome', is a complication of acute vaso-occlusive disease characterized by pain and edema of the digits as well as the dorsum of the hands or feet, or both simultaneously, often accompanied by increased local temperature and erythema. There were no patients with dactylitis events. Therefore, there were no observations which met the report criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 27, Year 2

Population: Safety analysis set - for treated participants with a valid measurement without a protocol deviation with impact.

Hemoglobin is a protein that carries oxygen through the body. It attaches to red blood cells, delivers oxygen throughout the body, and transports carbon dioxide back to the lungs. In sickle cell disease, red blood cells are crescent or sickle-shaped due to a genetic mutation, and those sickled red blood cells can clog blood flow, causing debilitating pain and even organ damage.

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=39 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=9 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=36 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=11 Participants Age 2 to \<6 years, 8.5 mg/kg
Absolute Change From Baseline in Hemoglobin Week 27	-1.26 g/L Standard Deviation 11.472	2.33 g/L Standard Deviation 6.856	-0.33 g/L Standard Deviation 7.015	1.55 g/L Standard Deviation 9.905
Absolute Change From Baseline in Hemoglobin End Of Treatment / Year 2 (n=24,6,11,2)	-5.38 g/L Standard Deviation 11.088	2.33 g/L Standard Deviation 7.941	-1.18 g/L Standard Deviation 11.677	15.00 g/L Standard Deviation 1.414

SECONDARY outcome

Timeframe: up to Year 2

Population: Full analysis set - for treated participants with a valid measurement without a protocol deviation with impact.

Anti-drug antibodies (ADA) are antibodies elicited from therapeutics and they are used to measure immunogenicity.

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=50 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=13 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=39 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=14 Participants Age 2 to \<6 years, 8.5 mg/kg
Immunogenicity: Measurement of Anti-drug Antibodies (ADA) to Crizanlizumab Baseline - Negative	50 Participants	13 Participants	39 Participants	14 Participants
Immunogenicity: Measurement of Anti-drug Antibodies (ADA) to Crizanlizumab Baseline - Positive	0 Participants	0 Participants	0 Participants	0 Participants
Immunogenicity: Measurement of Anti-drug Antibodies (ADA) to Crizanlizumab Baseline - Missing	0 Participants	0 Participants	1 Participants	0 Participants
Immunogenicity: Measurement of Anti-drug Antibodies (ADA) to Crizanlizumab Post-baseline - Any positive	0 Participants	1 Participants	1 Participants	0 Participants
Immunogenicity: Measurement of Anti-drug Antibodies (ADA) to Crizanlizumab Post-baseline - only last sample positive	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, up to Year 2

Population: Safety analysis set - for treated participants with a valid measurement without a protocol deviation with impact

QTcF = QT interval corrected by Fridericia's formula QTcB = Corrected QT interval Bazett's Formula QT = QT interval PR = PR interval QRS = QRS interval RR = RR interval HR = heart rate

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=49 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=13 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=40 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=13 Participants Age 2 to \<6 years, 8.5 mg/kg
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments QTcF (ms)-Increase >30 to <=60 ms (n=49,13,37,12)	1 Participants	1 Participants	2 Participants	1 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments QTcF (ms)- Increase >60 ms (n=49,13,37,12)	0 Participants	0 Participants	0 Participants	0 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments QTcF (ms)- New >450 to <=480 ms (n=49,13,40,13)	3 Participants	0 Participants	0 Participants	0 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments QTcF (ms)- New >480 to <=500 ms (n=49,13,40,13)	0 Participants	0 Participants	1 Participants	0 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments QTcF (ms)-New >500 ms (n=49,13,40,13)	0 Participants	0 Participants	0 Participants	0 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments QTcB (ms)-Increase >30 to <=60 ms (n=49,13,37,12)	12 Participants	3 Participants	7 Participants	1 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments QTcB (ms)-Increase >60 ms (n=49,13,37,12)	0 Participants	0 Participants	0 Participants	0 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments QTcB (ms)-New >450 to <=480 ms (n=40,12,35,13)	10 Participants	2 Participants	14 Participants	6 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments QTcB (ms)-New >480 to <=500 ms (n=49,13,40,13)	3 Participants	0 Participants	1 Participants	0 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments QTcB (ms)-New >500 ms (n=49,13,40,13)	0 Participants	0 Participants	0 Participants	0 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments QT (ms)-Increase >30 to <=60 ms (n=49,13,37,12)	13 Participants	5 Participants	17 Participants	3 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments QT (ms)-Increase >60 ms (n=49,13,37,12)	2 Participants	0 Participants	2 Participants	0 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments QT (ms)-New >450 to <=480 ms (n=49,13,40,13)	0 Participants	0 Participants	0 Participants	0 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments QT (ms)-New >480 to <=500 ms (n=49,13,40,13)	0 Participants	0 Participants	0 Participants	0 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments QT (ms)-New >500 ms (n=49,13,40,13)	0 Participants	0 Participants	0 Participants	0 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments PR (ms)-Increase >25% and PR >200 ms (n=48,13,37,12)	0 Participants	0 Participants	0 Participants	0 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments PR (ms)-New PR >200 ms (n=48,13,40,13)	2 Participants	0 Participants	0 Participants	0 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments QRS (ms)- Increase >25% and QRS >120 ms (n=49,13,37,12)	0 Participants	0 Participants	0 Participants	0 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments QRS (ms)-New QRS >120 ms (n=49,13,40,13)	0 Participants	0 Participants	0 Participants	0 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments RR (ms)-Increase >25% and RR >1200 ms (n=49,13,37,12)	1 Participants	0 Participants	0 Participants	0 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments RR (ms)-Decrease >25% and RR <600 ms (n=49,12,34,7)	0 Participants	1 Participants	2 Participants	0 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments HR (bpm)-Increase >25% and HR >100 bpm (n=49,12,34,7)	1 Participants	1 Participants	3 Participants	0 Participants
Notable On-treatment Findings From the Electrocardiogram (ECG) Assessments HR (bpm)-Decrease >25% and HR <50 bpm (n=49,13,37,12)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 51

Population: Full analysis set - only for participants at risk of delayed puberty, (i.e., excludes participants who already reached puberty at study start.)

As assessed per Tanner criteria. The number of Participants Analyzed row refer to participants who have not started puberty and have not had delayed puberty prior to start date of study treatment. Delayed puberty in females is defined as failure to attain Tanner Stage 2 (for both breast development and pubic hair) by age 13, or absence of menarche by age 15 or within 5 years of attainment of Tanner Stage 2.

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=3 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=12 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=5 Participants Age 2 to \<6 years, 8.5 mg/kg
Growth and Sexual Maturation Assessments (Tanner Stage) - Abnormalities - for Female Participants at Risk of Delayed Puberty at Start Date of Study Treatment Delayed puberty = yes	—	0 Participants	0 Participants	0 Participants
Growth and Sexual Maturation Assessments (Tanner Stage) - Abnormalities - for Female Participants at Risk of Delayed Puberty at Start Date of Study Treatment Delayed puberty = no	—	0 Participants	0 Participants	0 Participants
Growth and Sexual Maturation Assessments (Tanner Stage) - Abnormalities - for Female Participants at Risk of Delayed Puberty at Start Date of Study Treatment Delayed puberty = unknown (i.e., not applicable because pt not yet in age range for puberty)	—	3 Participants	12 Participants	5 Participants

SECONDARY outcome

Timeframe: Week 51

Population: Full analysis set - only for participants at risk of delayed puberty, (i.e., excludes participants who already reached puberty at study start.)

As assessed per Tanner criteria. The number of Participants Analyzed row refer to participants who have not started puberty and have not had delayed puberty prior to start date of study treatment. Delayed puberty in males is defined as failure to attain Tanner Stage 2 (for both genitalia and pubic hair) by age 14.

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=4 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=7 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=18 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=9 Participants Age 2 to \<6 years, 8.5 mg/kg
Growth and Sexual Maturation Assessments (Tanner Stage) - Abnormalities - for Male Participants at Risk of Delayed Puberty at Start Date of Study Treatment Delayed puberty = yes	0 Participants	0 Participants	0 Participants	0 Participants
Growth and Sexual Maturation Assessments (Tanner Stage) - Abnormalities - for Male Participants at Risk of Delayed Puberty at Start Date of Study Treatment Delayed puberty = no	4 Participants	0 Participants	0 Participants	0 Participants
Growth and Sexual Maturation Assessments (Tanner Stage) - Abnormalities - for Male Participants at Risk of Delayed Puberty at Start Date of Study Treatment Delayed puberty = unknown (i.e., not applicable because pt not yet in age range for puberty)	0 Participants	7 Participants	18 Participants	9 Participants

SECONDARY outcome

Timeframe: Week 3, Week 7, Week 11, Week 15, Week 19, Week 23, Week 27, Week 31, Week 35, Week 39, Week 43, Week 47 and Week 51 (Day 1, 0 hr (pre-dose))

Population: Pharmacokinetic analysis set 1 - for treated participants with a valid measurement without a protocol deviation with impact.

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=11 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=12 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=13 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=12 Participants Age 2 to \<6 years, 8.5 mg/kg
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Part A Week 3 Day 1, 0 hr (pre-dose) (n=11,12,13,10)	16.8 µg/mL Standard Deviation 4.40	14.1 µg/mL Standard Deviation 5.61	30.1 µg/mL Standard Deviation 6.17	19.8 µg/mL Standard Deviation 5.62
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Part A Week 7 Day 1, 0 hr (pre-dose) (n=9,12,12,12)	10.7 µg/mL Standard Deviation 3.30	8.70 µg/mL Standard Deviation 5.32	22.1 µg/mL Standard Deviation 8.09	13.4 µg/mL Standard Deviation 3.21
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Part A Week 11 Day 1, 0 hr (pre-dose) (n=9,11,12,11)	10.2 µg/mL Standard Deviation 4.92	6.02 µg/mL Standard Deviation 4.43	20.1 µg/mL Standard Deviation 9.36	11.0 µg/mL Standard Deviation 3.80
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Part A Week 15 Day 1, 0 hr (pre-dose) (n=7,9,11,12)	9.42 µg/mL Standard Deviation 6.47	8.45 µg/mL Standard Deviation 2.93	20.4 µg/mL Standard Deviation 7.22	10.3 µg/mL Standard Deviation 5.84
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Part A Week 19 Day 1, 0 hr (pre-dose) (n=6,9,12,11)	6.77 µg/mL Standard Deviation 4.53	7.75 µg/mL Standard Deviation 4.92	18.8 µg/mL Standard Deviation 5.28	10.2 µg/mL Standard Deviation 5.93
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Part A Week 23 Day 1, 0 hr (pre-dose) (n=9,12,12,10)	6.17 µg/mL Standard Deviation 3.92	7.15 µg/mL Standard Deviation 5.23	20.0 µg/mL Standard Deviation 6.74	10.6 µg/mL Standard Deviation 5.24
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Part A Week 27 Day 1, 0 hr (pre-dose) (n=9,10,12,10)	8.05 µg/mL Standard Deviation 5.32	7.70 µg/mL Standard Deviation 5.93	22.4 µg/mL Standard Deviation 8.71	11.8 µg/mL Standard Deviation 9.30
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Part A Week 31 Day 1, 0 hr (pre-dose) (n=6,10,11,10)	9.46 µg/mL Standard Deviation 4.34	8.57 µg/mL Standard Deviation 6.17	19.3 µg/mL Standard Deviation 6.36	9.68 µg/mL Standard Deviation 8.29
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Part A Week 35 Day 1, 0 hr (pre-dose) (n=5,11,10,9)	12.0 µg/mL Standard Deviation 6.04	6.88 µg/mL Standard Deviation 3.04	17.9 µg/mL Standard Deviation 8.03	8.43 µg/mL Standard Deviation 6.78
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Part A Week 39 Day 1, 0 hr (pre-dose) (n=7,11,10,11)	4.93 µg/mL Standard Deviation 3.00	7.04 µg/mL Standard Deviation 5.75	19.9 µg/mL Standard Deviation 5.21	12.8 µg/mL Standard Deviation 7.98
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Part A Week 43 Day 1, 0 hr (pre-dose) (n=8,10,11,8)	9.23 µg/mL Standard Deviation 4.73	7.45 µg/mL Standard Deviation 5.66	18.0 µg/mL Standard Deviation 8.07	12.8 µg/mL Standard Deviation 4.95
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Part A Week 47 Day 1, 0 hr (pre-dose) (n=8,8,10,10)	7.32 µg/mL Standard Deviation 3.84	10.4 µg/mL Standard Deviation 7.29	14.6 µg/mL Standard Deviation 8.22	10.5 µg/mL Standard Deviation 9.26
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Part A Week 51 Day 1, 0 hr (pre-dose) (n=5,9,10,8)	9.78 µg/mL Standard Deviation 6.61	9.44 µg/mL Standard Deviation 8.22	12.8 µg/mL Standard Deviation 10.6	10.3 µg/mL Standard Deviation 3.21

SECONDARY outcome

Timeframe: Week 3, Week 7, Week 11, Week 15, Week 19, Week 23, Week 27, Week 31, Week 35, Week 39, Week 43, Week 47 and Week 51 (0 hr (pre-dose))

Population: Pharmacokinetic analysis set 2 - for treated participants with a valid measurement without a protocol deviation with impact.

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=45 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=12 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=36 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=13 Participants Age 2 to \<6 years, 8.5 mg/kg
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Parts A and B Week 3 Day 1, 0 hr (pre-dose) (n=45,12,36,11)	16.6 µg/mL Standard Deviation 4.40	14.1 µg/mL Standard Deviation 5.61	23.6 µg/mL Standard Deviation 7.54	20.0 µg/mL Standard Deviation 5.37
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Parts A and B Week 7 Day 1, 0 hr (pre-dose) (n=44,12,35,13)	10.3 µg/mL Standard Deviation 5.49	8.70 µg/mL Standard Deviation 5.32	16.3 µg/mL Standard Deviation 7.50	14.4 µg/mL Standard Deviation 4.57
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Parts A and B Week 11 Day 1, 0 hr (pre-dose)(n=45,11,33,11)	9.18 µg/mL Standard Deviation 5.57	6.02 µg/mL Standard Deviation 4.43	15.3 µg/mL Standard Deviation 7.78	11.0 µg/mL Standard Deviation 3.80
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Parts A and B Week 15 Day 1, 0 hr (pre-dose) (n=39,9,33,12)	8.65 µg/mL Standard Deviation 5.73	8.45 µg/mL Standard Deviation 2.93	16.7 µg/mL Standard Deviation 7.34	10.3 µg/mL Standard Deviation 5.84
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Parts A and B Week 19 Day 1, 0 hr (pre-dose) (n=38,9,35,11)	8.13 µg/mL Standard Deviation 5.65	7.75 µg/mL Standard Deviation 4.92	17.5 µg/mL Standard Deviation 5.93	10.2 µg/mL Standard Deviation 5.93
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Parts A and B Week 23 Day 1, 0 hr (pre-dose) (n=43,12,35,10)	7.09 µg/mL Standard Deviation 4.45	7.15 µg/mL Standard Deviation 5.23	16.6 µg/mL Standard Deviation 6.90	10.6 µg/mL Standard Deviation 5.24
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Parts A and B Week 27 Day 1, 0 hr (pre-dose) (n=40,10,34,10)	7.07 µg/mL Standard Deviation 4.26	7.70 µg/mL Standard Deviation 5.93	16.5 µg/mL Standard Deviation 8.45	11.8 µg/mL Standard Deviation 9.30
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Parts A and B Week 31 Day 1, 0 hr (pre-dose) (n=39,10,35,10)	7.30 µg/mL Standard Deviation 4.80	8.57 µg/mL Standard Deviation 6.17	16.1 µg/mL Standard Deviation 7.57	9.68 µg/mL Standard Deviation 8.29
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Parts A and B Week 35 Day 1, 0 hr (pre-dose) (n=35,11,32,10)	8.96 µg/mL Standard Deviation 4.94	6.88 µg/mL Standard Deviation 3.04	13.6 µg/mL Standard Deviation 7.75	10.0 µg/mL Standard Deviation 8.11
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Parts A and B Week 39 Day 1, 0 hr (pre-dose) (n=38,11,35,12)	7.69 µg/mL Standard Deviation 5.46	7.04 µg/mL Standard Deviation 5.75	14.2 µg/mL Standard Deviation 7.79	13.4 µg/mL Standard Deviation 7.89
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Parts A and B Week 43 Day 1, 0 hr (pre-dose) (n=35,10,34,9)	8.68 µg/mL Standard Deviation 4.50	7.45 µg/mL Standard Deviation 5.66	14.8 µg/mL Standard Deviation 6.94	13.6 µg/mL Standard Deviation 5.15
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Parts A and B Week 47 Day 1, 0 hr (pre-dose)	8.99 µg/mL Standard Deviation 5.76	10.4 µg/mL Standard Deviation 7.29	13.8 µg/mL Standard Deviation 6.80	10.5 µg/mL Standard Deviation 9.26
PK Pre-dose Concentrations of Crizanlizumab Prior to Each Study Drug Dose - Parts A and B Week 51 Day 1, 0 hr (pre-dose)	8.48 µg/mL Standard Deviation 5.48	9.44 µg/mL Standard Deviation 8.22	13.4 µg/mL Standard Deviation 7.90	11.6 µg/mL Standard Deviation 4.90

SECONDARY outcome

Timeframe: Weeks 3, 7, 11,15, 19, 23, 27, 31, 35, 39, 43,47,51 (Day 1, 0 hr (pre-dose))

Population: Pharmacodynamic analysis set 1 - for treated participants with a valid measurement without a protocol deviation with impact.

A PD marker of crizanlizumab is the ex vivo P-selectin inhibition measured by a surface plasmon resonance assay using human serum samples. Crizanlizumab in serum samples binds to spiked Psel-Ig (P-selectin coupled to Ig) and inhibits its binding to a PSGL1 peptide.

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=11 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=12 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=13 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=10 Participants Age 2 to \<6 years, 8.5 mg/kg
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A Week 3 Day 1, 0 hr (pre-dose) (n=11,12,13,9)	100 % inhibition P-selectin Standard Deviation 0.0924	97.9 % inhibition P-selectin Standard Deviation 2.97	99.1 % inhibition P-selectin Standard Deviation 1.41	98.6 % inhibition P-selectin Standard Deviation 2.54
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A Week 7 Day 1, 0 hr (pre-dose) (n=9,11,12,10)	99.0 % inhibition P-selectin Standard Deviation 1.61	94.2 % inhibition P-selectin Standard Deviation 12.2	98.5 % inhibition P-selectin Standard Deviation 3.48	98.9 % inhibition P-selectin Standard Deviation 1.91
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A Week 11 Day 1, 0 hr (pre-dose) (n=9,9,12,9)	97.7 % inhibition P-selectin Standard Deviation 4.56	80.8 % inhibition P-selectin Standard Deviation 32.4	98.5 % inhibition P-selectin Standard Deviation 2.93	98.4 % inhibition P-selectin Standard Deviation 2.50
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A Week 15 Day 1, 0 hr (pre-dose) (n=6,8,11,10)	96.6 % inhibition P-selectin Standard Deviation 8.04	99.8 % inhibition P-selectin Standard Deviation 0.422	99.2 % inhibition P-selectin Standard Deviation 1.86	91.7 % inhibition P-selectin Standard Deviation 19.8
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A Week 19 Day 1, 0 hr (pre-dose) (n=6,9,12,10)	88.6 % inhibition P-selectin Standard Deviation 20.6	83.5 % inhibition P-selectin Standard Deviation 34.8	99.2 % inhibition P-selectin Standard Deviation 1.54	96.7 % inhibition P-selectin Standard Deviation 5.51
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A Week 23 Day 1, 0 hr (pre-dose) (n=9,10,11,9)	83.8 % inhibition P-selectin Standard Deviation 28.9	91.2 % inhibition P-selectin Standard Deviation 14.0	99.5 % inhibition P-selectin Standard Deviation 1.24	92.2 % inhibition P-selectin Standard Deviation 15.7
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A Week 27 Day 1, 0 hr (pre-dose) (n=9,9,11,8)	88.0 % inhibition P-selectin Standard Deviation 25.0	90.8 % inhibition P-selectin Standard Deviation 20.4	99.4 % inhibition P-selectin Standard Deviation 1.36	85.4 % inhibition P-selectin Standard Deviation 19.1
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A Week 31 Day 1, 0 hr (pre-dose) (n=6,9,9,9)	97.8 % inhibition P-selectin Standard Deviation 2.83	88.9 % inhibition P-selectin Standard Deviation 21.0	99.6 % inhibition P-selectin Standard Deviation 1.30	75.5 % inhibition P-selectin Standard Deviation 37.9
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A Week 35 Day 1, 0 hr (pre-dose) (n=5,10,8,9)	97.2 % inhibition P-selectin Standard Deviation 6.04	92.3 % inhibition P-selectin Standard Deviation 10.6	97.9 % inhibition P-selectin Standard Deviation 3.81	67.4 % inhibition P-selectin Standard Deviation 42.1
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A Week 39 Day 1, 0 hr (pre-dose) (n=7,7,8,9)	80.8 % inhibition P-selectin Standard Deviation 28.0	88.6 % inhibition P-selectin Standard Deviation 25.3	99.1 % inhibition P-selectin Standard Deviation 2.01	87.6 % inhibition P-selectin Standard Deviation 19.2
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A Week 43 Day 1, 0 hr (pre-dose) (n=8,3,9,6)	96.7 % inhibition P-selectin Standard Deviation 4.19	99.0 % inhibition P-selectin Standard Deviation 1.67	98.8 % inhibition P-selectin Standard Deviation 2.14	98.8 % inhibition P-selectin Standard Deviation 2.37
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A Week 47 Day 1, 0 hr (pre-dose) (n=8,2,8,8)	87.1 % inhibition P-selectin Standard Deviation 30.5	98.8 % inhibition P-selectin Standard Deviation 1.77	98.1 % inhibition P-selectin Standard Deviation 3.73	69.8 % inhibition P-selectin Standard Deviation 44.0
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A Week 51 Day 1, 0 hr (pre-dose) (n=5,3,8,7)	80.9 % inhibition P-selectin Standard Deviation 34.0	95.4 % inhibition P-selectin Standard Deviation 4.24	98.9 % inhibition P-selectin Standard Deviation 1.86	92.1 % inhibition P-selectin Standard Deviation 13.0

SECONDARY outcome

Timeframe: Weeks 3, 7, 11,15, 19, 23, 27, 31, 35, 39, 43,47,51 (Day 1, 0 hr (pre-dose))

Population: Pharmacodynamic analysis set 2 - for treated participants with a valid measurement without a protocol deviation with impact.

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=42 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=12 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=36 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=12 Participants Age 2 to \<6 years, 8.5 mg/kg
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A and B Week 3 Day 1, 0 hr (pre-dose) (n=42,12,36,11)	99.3 % inhibition P-selectin Standard Deviation 2.14	97.9 % inhibition P-selectin Standard Deviation 2.97	98.3 % inhibition P-selectin Standard Deviation 3.74	97.6 % inhibition P-selectin Standard Deviation 3.71
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A and B Week 7 Day 1, 0 hr (pre-dose) (n=41,12,35,12)	93.7 % inhibition P-selectin Standard Deviation 17.0	94.6 % inhibition P-selectin Standard Deviation 11.7	97.1 % inhibition P-selectin Standard Deviation 7.36	97.3 % inhibition P-selectin Standard Deviation 5.92
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A and B Week 11 Day 1, 0 hr (pre-dose) (n=41,10,33,10)	92.7 % inhibition P-selectin Standard Deviation 17.8	82.3 % inhibition P-selectin Standard Deviation 30.9	97.5 % inhibition P-selectin Standard Deviation 6.08	98.3 % inhibition P-selectin Standard Deviation 2.39
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A and B Week 15 Day 1, 0 hr (pre-dose) (n=39,9,33,11)	92.6 % inhibition P-selectin Standard Deviation 18.9	98.9 % inhibition P-selectin Standard Deviation 2.90	96.8 % inhibition P-selectin Standard Deviation 8.46	92.5 % inhibition P-selectin Standard Deviation 19.0
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A and B Week 19 Day 1, 0 hr (pre-dose) (n=36,9,35,10)	92.4 % inhibition P-selectin Standard Deviation 12.3	83.5 % inhibition P-selectin Standard Deviation 34.8	96.8 % inhibition P-selectin Standard Deviation 7.36	96.7 % inhibition P-selectin Standard Deviation 5.51
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A and B Week 23 Day 1, 0 hr (pre-dose) (n=42,11,34,9)	86.5 % inhibition P-selectin Standard Deviation 26.3	92.0 % inhibition P-selectin Standard Deviation 13.5	94.2 % inhibition P-selectin Standard Deviation 17.6	92.2 % inhibition P-selectin Standard Deviation 15.7
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A and B Week 27 Day 1, 0 hr (pre-dose) (n=37,10,33,9)	87.6 % inhibition P-selectin Standard Deviation 26.1	91.6 % inhibition P-selectin Standard Deviation 19.4	95.4 % inhibition P-selectin Standard Deviation 10.4	87.0 % inhibition P-selectin Standard Deviation 18.5
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A and B Week 31 Day 1, 0 hr (pre-dose) (n=36,10,32,9)	90.9 % inhibition P-selectin Standard Deviation 18.7	89.1 % inhibition P-selectin Standard Deviation 19.8	97.3 % inhibition P-selectin Standard Deviation 7.02	75.5 % inhibition P-selectin Standard Deviation 37.9
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A and B Week 35 Day 1, 0 hr (pre-dose) (n=32,11,29,10)	93.1 % inhibition P-selectin Standard Deviation 18.0	92.8 % inhibition P-selectin Standard Deviation 10.3	92.7 % inhibition P-selectin Standard Deviation 16.4	70.6 % inhibition P-selectin Standard Deviation 41.0
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A and B Week 39 Day 1, 0 hr (pre-dose) (n=33,8,33,11)	85.4 % inhibition P-selectin Standard Deviation 23.6	89.7 % inhibition P-selectin Standard Deviation 23.6	92.7 % inhibition P-selectin Standard Deviation 18.7	89.8 % inhibition P-selectin Standard Deviation 17.9
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A and B Week 43 Day 1, 0 hr (pre-dose) (n=31,3,32,8)	93.1 % inhibition P-selectin Standard Deviation 15.4	99.0 % inhibition P-selectin Standard Deviation 1.67	95.3 % inhibition P-selectin Standard Deviation 11.0	99.1 % inhibition P-selectin Standard Deviation 2.08
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A and B Week 47 Day 1, 0 hr (pre-dose) (n=28,2,32,9)	91.7 % inhibition P-selectin Standard Deviation 17.7	98.8 % inhibition P-selectin Standard Deviation 1.77	95.8 % inhibition P-selectin Standard Deviation 7.45	73.1 % inhibition P-selectin Standard Deviation 42.4
Percent P-selectin Inhibition of Crizanlizumab Prior to Dosing - Part A and B Week 51 Day 1, 0 hr (pre-dose) (n=27,3,26,9)	86.4 % inhibition P-selectin Standard Deviation 25.8	95.4 % inhibition P-selectin Standard Deviation 4.24	92.5 % inhibition P-selectin Standard Deviation 19.3	93.8 % inhibition P-selectin Standard Deviation 11.8

SECONDARY outcome

Population: Safety analysis set - all treated participants

Outcome measures

Outcome measures
Measure	Age 12 to <18 Years, 5 mg/kg n=50 Participants Age 12 to \<18 years, 5 mg/kg	Age 6 to <12 Years, 5 mg/kg n=13 Participants Age 6 to \<12 years, 5 mg/kg	Age 6 to <12 Years, 8.5 mg/kg n=40 Participants Age 6 to \<12 years, 8.5 mg/kg	Age 2 to <6 Years, 8.5 mg/kg n=14 Participants Age 2 to \<6 years, 8.5 mg/kg
Adverse Events by Preferred Term Related to Study Treatment Number of participants with at least one event	16 Participants	5 Participants	14 Participants	4 Participants
Adverse Events by Preferred Term Related to Study Treatment Infusion related reaction	5 Participants	2 Participants	3 Participants	1 Participants
Adverse Events by Preferred Term Related to Study Treatment Back pain	3 Participants	0 Participants	4 Participants	2 Participants
Adverse Events by Preferred Term Related to Study Treatment Nausea	3 Participants	0 Participants	1 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Pain in extremity	2 Participants	0 Participants	2 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Sickle cell anaemia with crisis	0 Participants	0 Participants	2 Participants	1 Participants
Adverse Events by Preferred Term Related to Study Treatment Arthralgia	0 Participants	1 Participants	1 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Conjunctivitis	1 Participants	1 Participants	0 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Dizziness	2 Participants	0 Participants	0 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Headache	1 Participants	0 Participants	1 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Infusion site pain	1 Participants	0 Participants	1 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Myalgia	1 Participants	1 Participants	0 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Neutropenia	0 Participants	0 Participants	1 Participants	1 Participants
Adverse Events by Preferred Term Related to Study Treatment Pain	1 Participants	1 Participants	0 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Vomiting	2 Participants	0 Participants	0 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Abdominal pain	0 Participants	1 Participants	0 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Agitation	1 Participants	0 Participants	0 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Alopecia	0 Participants	0 Participants	1 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Anaemia	0 Participants	0 Participants	1 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Asthenia	0 Participants	0 Participants	1 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Blood bilirubin increased	1 Participants	0 Participants	0 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Blood creatine phosphokinase increased	1 Participants	0 Participants	0 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Dyspnoea	0 Participants	1 Participants	0 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Fatigue	1 Participants	0 Participants	0 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Hot flush	1 Participants	0 Participants	0 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Hypersensitivity	0 Participants	0 Participants	1 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Malaise	0 Participants	1 Participants	0 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Muscle fatigue	1 Participants	0 Participants	0 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Neck pain	1 Participants	0 Participants	0 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Paraesthesia	0 Participants	0 Participants	1 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Pruritus	0 Participants	1 Participants	0 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Pyrexia	0 Participants	1 Participants	0 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Sacral pain	0 Participants	0 Participants	1 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Spinal pain	0 Participants	0 Participants	1 Participants	0 Participants
Adverse Events by Preferred Term Related to Study Treatment Vascular access complication	0 Participants	1 Participants	0 Participants	0 Participants

Adverse Events

Age 12 to < 18 Years, 5 mg/kg

Serious events: 18 serious events

Other events: 46 other events

Deaths: 1 deaths

Age 6 to < 12 Years, 5 mg/kg

Serious events: 9 serious events

Other events: 13 other events

Deaths: 0 deaths

Age 6 to < 12 Years, 8.5 mg/kg

Serious events: 20 serious events

Other events: 36 other events

Deaths: 0 deaths

Age 2 to < 6 Years, 8.5 mg/kg

Serious events: 12 serious events

Other events: 13 other events

Deaths: 0 deaths

All Participants

Serious events: 59 serious events

Other events: 108 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Age 12 to < 18 Years, 5 mg/kg n=50 participants at risk Age 12 to \< 18 years, 5 mg/kg	Age 6 to < 12 Years, 5 mg/kg n=13 participants at risk Age 6 to \< 12 years, 5 mg/kg	Age 6 to < 12 Years, 8.5 mg/kg n=40 participants at risk Age 6 to \< 12 years, 8.5 mg/kg	Age 2 to < 6 Years, 8.5 mg/kg n=14 participants at risk Age 2 to \< 6 years, 8.5 mg/kg	All Participants n=117 participants at risk All Participants / All arms combined / Total
Infections and infestations Encephalitis	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Influenza	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Escherichia urinary tract infection	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Gastroenteritis	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Blood and lymphatic system disorders Anaemia	4.0% 2/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	12.5% 5/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 9/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Blood and lymphatic system disorders Mesenteric lymphadenitis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Blood and lymphatic system disorders Sickle cell anaemia with crisis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Gastrointestinal disorders Abdominal pain	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Gastrointestinal disorders Constipation	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Gastrointestinal disorders Pancreatitis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Gastrointestinal disorders Vomiting	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
General disorders Hyperthermia	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
General disorders Pain	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.0% 2/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	21.4% 3/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.1% 6/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
General disorders Pyrexia	4.0% 2/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	15.4% 2/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	28.6% 4/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 9/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Hepatobiliary disorders Cholecystitis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	15.4% 2/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Hepatobiliary disorders Cholecystitis acute	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.0% 2/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.6% 3/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Hepatobiliary disorders Cholelithiasis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Hepatobiliary disorders Jaundice	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Immune system disorders Anaphylactic reaction	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Bronchitis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations COVID-19	8.0% 4/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	14.3% 2/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	6.0% 7/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Cellulitis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.5% 3/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.6% 3/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Cystitis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Device related infection	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Lower respiratory tract infection	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Meningitis bacterial	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Metapneumovirus infection	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Parainfluenzae virus infection	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Parvovirus B19 infection	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Pharyngitis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Pneumonia	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	10.0% 4/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	21.4% 3/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 9/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Pneumonia bacterial	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Pneumonia viral	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Pyelonephritis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Respiratory tract infection	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Respiratory tract infection viral	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Sepsis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Septic shock	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Thrombophlebitis septic	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Tonsillitis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Upper respiratory tract infection	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Urinary tract infection	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Viral infection	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.0% 2/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.6% 3/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Injury, poisoning and procedural complications Brain herniation	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Injury, poisoning and procedural complications Infusion related reaction	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Injury, poisoning and procedural complications Post procedural haemorrhage	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Investigations Human rhinovirus test positive	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Metabolism and nutrition disorders Dehydration	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Musculoskeletal and connective tissue disorders Back pain	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	21.4% 3/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	3.4% 4/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Musculoskeletal and connective tissue disorders Costochondritis	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Musculoskeletal and connective tissue disorders Fasciitis	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Musculoskeletal and connective tissue disorders Myositis	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Nervous system disorders Brain oedema	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Nervous system disorders Status migrainosus	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Nervous system disorders Syncope	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Respiratory, thoracic and mediastinal disorders Acute chest syndrome	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Vascular disorders Superficial vein thrombosis	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.

Other adverse events

Other adverse events
Measure	Age 12 to < 18 Years, 5 mg/kg n=50 participants at risk Age 12 to \< 18 years, 5 mg/kg	Age 6 to < 12 Years, 5 mg/kg n=13 participants at risk Age 6 to \< 12 years, 5 mg/kg	Age 6 to < 12 Years, 8.5 mg/kg n=40 participants at risk Age 6 to \< 12 years, 8.5 mg/kg	Age 2 to < 6 Years, 8.5 mg/kg n=14 participants at risk Age 2 to \< 6 years, 8.5 mg/kg	All Participants n=117 participants at risk All Participants / All arms combined / Total
Blood and lymphatic system disorders Anaemia	16.0% 8/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	10.0% 4/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	21.4% 3/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	13.7% 16/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Blood and lymphatic system disorders Lymphocytosis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Blood and lymphatic system disorders Neutropenia	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.5% 3/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	14.3% 2/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.1% 6/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Blood and lymphatic system disorders Sickle cell anaemia with crisis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	15.4% 2/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.0% 2/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	3.4% 4/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	10.0% 4/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	14.3% 2/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.1% 6/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Cardiac disorders Bundle branch block right	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Cardiac disorders Right ventricular enlargement	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Ear and labyrinth disorders Cerumen impaction	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Ear and labyrinth disorders Ear pain	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Eye disorders Xerophthalmia	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Gastrointestinal disorders Abdominal pain	20.0% 10/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	38.5% 5/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	30.0% 12/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	23.9% 28/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Gastrointestinal disorders Abdominal pain upper	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.5% 3/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	3.4% 4/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Gastrointestinal disorders Constipation	18.0% 9/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	23.1% 3/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	15.0% 6/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	14.3% 2/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	17.1% 20/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Gastrointestinal disorders Diarrhoea	10.0% 5/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	12.5% 5/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	14.3% 2/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	11.1% 13/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Gastrointestinal disorders Gastritis	4.0% 2/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.6% 3/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Gastrointestinal disorders Nausea	18.0% 9/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	12.5% 5/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	12.0% 14/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Gastrointestinal disorders Odynophagia	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Gastrointestinal disorders Vomiting	28.0% 14/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	15.4% 2/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	10.0% 4/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	17.9% 21/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
General disorders Chest pain	6.0% 3/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	15.4% 2/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	10.0% 4/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	8.5% 10/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
General disorders Device related thrombosis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
General disorders Fatigue	6.0% 3/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	3.4% 4/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
General disorders Hyperthermia	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
General disorders Influenza like illness	4.0% 2/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.0% 2/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	4.3% 5/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
General disorders Malaise	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
General disorders Pain	4.0% 2/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	23.1% 3/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	10.0% 4/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	14.3% 2/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	9.4% 11/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
General disorders Pyrexia	24.0% 12/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	38.5% 5/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	40.0% 16/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	35.7% 5/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	32.5% 38/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Hepatobiliary disorders Biliary colic	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Hepatobiliary disorders Cholecystitis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Hepatobiliary disorders Cholelithiasis	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.5% 3/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	4.3% 5/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Hepatobiliary disorders Jaundice	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Bronchitis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations COVID-19	22.0% 11/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	10.0% 4/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	14.3% 2/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	15.4% 18/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Conjunctivitis	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.6% 3/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Eye infection	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Gastroenteritis	6.0% 3/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.5% 3/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.1% 6/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Influenza	4.0% 2/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	15.4% 2/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	20.0% 8/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	10.3% 12/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Nasopharyngitis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.0% 2/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	21.4% 3/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	4.3% 5/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Oral candidiasis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Otitis media	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.6% 3/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Pharyngitis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Pneumonia	6.0% 3/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	12.5% 5/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 9/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Respiratory tract infection	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	14.3% 2/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	3.4% 4/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Rhinitis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Sinusitis	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	15.4% 2/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	4.3% 5/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Suspected COVID-19	6.0% 3/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	3.4% 4/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Tonsillitis	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	15.4% 2/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.0% 2/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.1% 6/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Upper respiratory tract infection	18.0% 9/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.0% 2/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	28.6% 4/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	13.7% 16/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Urinary tract infection	12.0% 6/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	21.4% 3/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	9.4% 11/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Viral infection	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.0% 2/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.6% 3/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Injury, poisoning and procedural complications Eye contusion	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Injury, poisoning and procedural complications Eye injury	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Injury, poisoning and procedural complications Infusion related reaction	8.0% 4/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	15.4% 2/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.5% 3/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	8.5% 10/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Injury, poisoning and procedural complications Joint injury	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Injury, poisoning and procedural complications Limb injury	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.0% 2/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.6% 3/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Injury, poisoning and procedural complications Nasal injury	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Injury, poisoning and procedural complications Penis injury	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Injury, poisoning and procedural complications Skeletal injury	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Investigations Alanine aminotransferase increased	4.0% 2/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.0% 2/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	4.3% 5/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Investigations Amylase increased	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Investigations Anti factor Xa activity decreased	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Investigations Arterial flow velocity increased	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Investigations Aspartate aminotransferase increased	6.0% 3/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	15.4% 2/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.1% 6/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Investigations Blood alkaline phosphatase increased	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.6% 3/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Investigations Blood bilirubin increased	6.0% 3/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	4.3% 5/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Investigations Blood creatinine increased	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Investigations C-reactive protein increased	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	14.3% 2/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.6% 3/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Investigations Cardiac murmur	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Investigations Epstein-Barr virus test positive	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Investigations Gamma-glutamyltransferase increased	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Investigations Influenza A virus test negative	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Investigations Influenza virus test negative	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Investigations International normalised ratio increased	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Investigations Lymphocyte count decreased	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Investigations Polymerase chain reaction negative	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Investigations SARS-CoV-2 test negative	24.0% 12/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	23.1% 3/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	12.8% 15/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Investigations SARS-CoV-2 test positive	6.0% 3/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.6% 3/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Metabolism and nutrition disorders Decreased appetite	4.0% 2/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.6% 3/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Metabolism and nutrition disorders Hypokalaemia	6.0% 3/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.6% 3/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	14.3% 2/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Musculoskeletal and connective tissue disorders Arthralgia	22.0% 11/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	17.5% 7/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	17.1% 20/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Musculoskeletal and connective tissue disorders Back pain	22.0% 11/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	15.4% 2/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	22.5% 9/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	28.6% 4/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	22.2% 26/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Musculoskeletal and connective tissue disorders Bone infarction	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Musculoskeletal and connective tissue disorders Bone pain	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.6% 3/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	15.4% 2/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	4.3% 5/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Musculoskeletal and connective tissue disorders Myalgia	6.0% 3/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.0% 2/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.1% 6/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Musculoskeletal and connective tissue disorders Neck pain	4.0% 2/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	3.4% 4/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Musculoskeletal and connective tissue disorders Osteonecrosis	8.0% 4/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.5% 3/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	6.0% 7/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Musculoskeletal and connective tissue disorders Pain in extremity	22.0% 11/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	23.1% 3/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	25.0% 10/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	21.4% 3/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	23.1% 27/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Nervous system disorders Dizziness	10.0% 5/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	6.0% 7/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Nervous system disorders Headache	38.0% 19/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	30.8% 4/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	25.0% 10/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	21.4% 3/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	30.8% 36/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Psychiatric disorders Anxiety	8.0% 4/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	4.3% 5/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Psychiatric disorders Insomnia	6.0% 3/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.6% 3/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Psychiatric disorders Suicidal ideation	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Renal and urinary disorders Dysuria	6.0% 3/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.6% 3/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Renal and urinary disorders Haematuria	6.0% 3/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.6% 3/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Respiratory, thoracic and mediastinal disorders Asthma exercise induced	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	14.3% 2/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 5/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	15.4% 2/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	22.5% 9/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	35.7% 5/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	17.9% 21/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.0% 3/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	23.1% 3/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	6.8% 8/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.0% 2/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.6% 3/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.0% 3/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.0% 2/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.1% 6/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.0% 4/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.1% 6/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	1.7% 2/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.5% 1/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	2.6% 3/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	10.0% 5/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.0% 2/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	14.3% 2/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	8.5% 10/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Skin and subcutaneous tissue disorders Nail dystrophy	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Skin and subcutaneous tissue disorders Pruritus	8.0% 4/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	4.3% 5/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Skin and subcutaneous tissue disorders Rash	2.0% 1/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	5.0% 2/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	3.4% 4/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Vascular disorders Hypertension	4.0% 2/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	14.3% 2/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	3.4% 4/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Vascular disorders Pallor	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.7% 1/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.
Vascular disorders Phlebitis	0.00% 0/50 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/13 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.00% 0/40 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	7.1% 1/14 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.	0.85% 1/117 • Adverse events are reported from the first dose of study treatment until end of study treatment Week 103 plus 105 days post-treatment follow-up, up to a maximum timeframe of approximately 2 years and 3.25 months.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER