Trial Outcomes & Findings for Clinical Study In Infants With Rapidly Progressive Lysosomal Acid Lipase Deficiency (NCT NCT02193867)

NCT ID: NCT02193867

Last Updated: 2019-11-18

Results Overview

The number of participants experiencing severe TEAEs is presented for participants who received sebelipase alfa in this open-label study. Adverse events were obtained through spontaneous reporting or elicited by specific questioning or examination of the participant's parent or legal guardian. An adverse event was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant, whether or not causally related to administration of study drug. Adverse event severity was graded by the Investigator as mild, moderate, or severe based on definitions developed from Clinical Data Interchange Standards Consortium Study Data Tabulation Model standard terminology v3.1.1. Adverse events reporting was from the date of informed consent until completion of the follow-up visit at approximately 30 days after the last dose of study drug. A summary of all serious and other nonserious AEs regardless of causality is located in the Reported AE module.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: Screening through Month 37
• Results posted on: 2019-11-18

Participant Flow

A total of 6 sites were initiated, and participants were treated at 5 sites in 4 countries (United Kingdom [UK], United States [US], Finland, Italy). One study site in the US was initiated but did not screen or treat any participants.

The study consisted of a screening period of up to 3 weeks. Participants who met all eligibility criteria were enrolled, treated, and analyzed.

Participant milestones

Measure	Open-Label Sebelipase Alfa All participants initiated once weekly (qw) intravenous (IV) infusions with sebelipase alfa at a dose of 1 milligram/kilogram (mg/kg) qw. A participant who met protocol defined dose escalation criteria at a dose of 1 mg/kg qw could be considered for a dose escalation to 3 mg/kg qw. If a participant continued to meet dose escalation criteria after at least 4 infusions at a dose of 3 mg/kg qw, the participant could be considered for a further dose escalation to 5 mg/kg qw. Under country-specific provisions (UK only), participants could be considered for a further dose escalation to 7.5 mg/kg qw if a thorough case review indicated that a participant continued to have evidence of disease progression at a dose of 5 mg/kg qw. All dose escalations were contingent upon acceptable safety and tolerability of preceding infusions and were undertaken by mutual agreement of the Investigator and Sponsor and after approval by an independent safety committee.
Overall Study STARTED	10
Overall Study Received At Least 1 Dose Of Study Drug	10
Overall Study Completed 18 Months Of Treatment	8
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Open-Label Sebelipase Alfa All participants initiated once weekly (qw) intravenous (IV) infusions with sebelipase alfa at a dose of 1 milligram/kilogram (mg/kg) qw. A participant who met protocol defined dose escalation criteria at a dose of 1 mg/kg qw could be considered for a dose escalation to 3 mg/kg qw. If a participant continued to meet dose escalation criteria after at least 4 infusions at a dose of 3 mg/kg qw, the participant could be considered for a further dose escalation to 5 mg/kg qw. Under country-specific provisions (UK only), participants could be considered for a further dose escalation to 7.5 mg/kg qw if a thorough case review indicated that a participant continued to have evidence of disease progression at a dose of 5 mg/kg qw. All dose escalations were contingent upon acceptable safety and tolerability of preceding infusions and were undertaken by mutual agreement of the Investigator and Sponsor and after approval by an independent safety committee.
Overall Study Death	2
Overall Study Sponsor Study Termination	2

Baseline Characteristics

Clinical Study In Infants With Rapidly Progressive Lysosomal Acid Lipase Deficiency

Baseline characteristics by cohort

Measure	Open-Label Sebelipase Alfa n=10 Participants All participants initiated qw IV infusions with sebelipase alfa at a dose of 1 mg/kg qw. A participant who met protocol defined dose escalation criteria at a dose of 1 mg/kg qw could be considered for a dose escalation to 3 mg/kg qw. If a participant continued to meet dose escalation criteria after at least 4 infusions at a dose of 3 mg/kg qw, the participant could be considered for a further dose escalation to 5 mg/kg qw. Under country-specific provisions (UK only), participants could be considered for a further dose escalation to 7.5 mg/kg qw if a thorough case review indicated that a participant continued to have evidence of disease progression at a dose of 5 mg/kg qw. All dose escalations were contingent upon acceptable safety and tolerability of preceding infusions and were undertaken by mutual agreement of the Investigator and Sponsor and after approval by an independent safety committee.
Age, Continuous	4.13 months STANDARD_DEVIATION 2.859 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · American Indian or Alaska Native	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	6 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Egyptian	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Turkish Kurdish	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Screening through Month 37

Population: FAS: All participants who received any amount of sebelipase alfa (1.0, 3.0, 5.0, or 7.5 mg/kg qw) during the study and where applicable, met end point criteria.

The number of participants experiencing severe TEAEs is presented for participants who received sebelipase alfa in this open-label study. Adverse events were obtained through spontaneous reporting or elicited by specific questioning or examination of the participant's parent or legal guardian. An adverse event was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant, whether or not causally related to administration of study drug. Adverse event severity was graded by the Investigator as mild, moderate, or severe based on definitions developed from Clinical Data Interchange Standards Consortium Study Data Tabulation Model standard terminology v3.1.1. Adverse events reporting was from the date of informed consent until completion of the follow-up visit at approximately 30 days after the last dose of study drug. A summary of all serious and other nonserious AEs regardless of causality is located in the Reported AE module.

Outcome measures

Measure

Open-Label Sebelipase Alfa n=10 Participants All participants initiated qw IV infusions with sebelipase alfa at a dose of 1 mg/kg qw. A participant who met protocol defined dose escalation criteria at a dose of 1 mg/kg qw could be considered for a dose escalation to 3 mg/kg qw. If a participant continued to meet dose escalation criteria after at least 4 infusions at a dose of 3 mg/kg qw, the participant could be considered for a further dose escalation to 5 mg/kg qw. Under country-specific provisions (UK only), participants could be considered for a further dose escalation to 7.5 mg/kg qw if a thorough case review indicated that a participant continued to have evidence of disease progression at a dose of 5 mg/kg qw. All dose escalations were contingent upon acceptable safety and tolerability of preceding infusions and were undertaken by mutual agreement of the Investigator and Sponsor and after approval by an independent safety committee.

Participants Experiencing Severe Treatment-emergent Adverse Events (TEAEs)

7 Participants

SECONDARY outcome

Timeframe: Baseline through Month 12, Month 18, Month 24, and Month 36

Population: FAS: All participants who received any amount of sebelipase alfa (1.0, 3.0, 5.0, or 7.5 mg/kg qw) during the study and where applicable, met end point criteria.

The percentage of participants in the FAS who survived to 12, 18, 24, and 36 months of age. The exact confidence interval was calculated using the Clopper-Pearson method. Participants with unknown survival status at the age specified in the analysis were excluded. At 36 months, there were 2 participants who were alive and still on study who had not yet reached the age specified in the analysis. As such, these participants were excluded from the calculation of percent surviving.

Outcome measures

Measure	Open-Label Sebelipase Alfa n=10 Participants All participants initiated qw IV infusions with sebelipase alfa at a dose of 1 mg/kg qw. A participant who met protocol defined dose escalation criteria at a dose of 1 mg/kg qw could be considered for a dose escalation to 3 mg/kg qw. If a participant continued to meet dose escalation criteria after at least 4 infusions at a dose of 3 mg/kg qw, the participant could be considered for a further dose escalation to 5 mg/kg qw. Under country-specific provisions (UK only), participants could be considered for a further dose escalation to 7.5 mg/kg qw if a thorough case review indicated that a participant continued to have evidence of disease progression at a dose of 5 mg/kg qw. All dose escalations were contingent upon acceptable safety and tolerability of preceding infusions and were undertaken by mutual agreement of the Investigator and Sponsor and after approval by an independent safety committee.
Percentage Of Participants Surviving To 12, 18, 24, And 36 Months Of Age Month 12	90 percentage of participants Interval 55.5 to 99.7
Percentage Of Participants Surviving To 12, 18, 24, And 36 Months Of Age Month 18	80 percentage of participants Interval 44.4 to 97.5
Percentage Of Participants Surviving To 12, 18, 24, And 36 Months Of Age Month 24	80 percentage of participants Interval 44.4 to 97.5
Percentage Of Participants Surviving To 12, 18, 24, And 36 Months Of Age Month 36	75 percentage of participants Interval 34.9 to 96.8

SECONDARY outcome

Timeframe: Baseline through Month 36

Population: FAS: All participants who received any amount of sebelipase alfa (1.0, 3.0, 5.0, or 7.5 mg/kg qw) during the study and where applicable, met end point criteria.

Age at death for participants who died during the study. All deaths were assessed by the Investigator as unrelated to study drug.

Outcome measures

Measure

Open-Label Sebelipase Alfa n=2 Participants All participants initiated qw IV infusions with sebelipase alfa at a dose of 1 mg/kg qw. A participant who met protocol defined dose escalation criteria at a dose of 1 mg/kg qw could be considered for a dose escalation to 3 mg/kg qw. If a participant continued to meet dose escalation criteria after at least 4 infusions at a dose of 3 mg/kg qw, the participant could be considered for a further dose escalation to 5 mg/kg qw. Under country-specific provisions (UK only), participants could be considered for a further dose escalation to 7.5 mg/kg qw if a thorough case review indicated that a participant continued to have evidence of disease progression at a dose of 5 mg/kg qw. All dose escalations were contingent upon acceptable safety and tolerability of preceding infusions and were undertaken by mutual agreement of the Investigator and Sponsor and after approval by an independent safety committee.

Median Age At Death

9.33 months Interval 4.9 to 13.8

SECONDARY outcome

Timeframe: Baseline, Month 12, Month 24, and Month 36

Population: FAS: All participants who received any amount of sebelipase alfa (1.0, 3.0, 5.0, or 7.5 mg/kg qw) during the study and where applicable, met end point criteria.

This outcome measure evaluated the effects of sebelipase alfa on growth by measuring the changes from baseline in percentiles for WFA. Percentiles for WFA were summarized as observed values by visit. Baseline was defined as the last available assessment prior to the first infusion of sebelipase alfa.

Outcome measures

Measure	Open-Label Sebelipase Alfa n=9 Participants All participants initiated qw IV infusions with sebelipase alfa at a dose of 1 mg/kg qw. A participant who met protocol defined dose escalation criteria at a dose of 1 mg/kg qw could be considered for a dose escalation to 3 mg/kg qw. If a participant continued to meet dose escalation criteria after at least 4 infusions at a dose of 3 mg/kg qw, the participant could be considered for a further dose escalation to 5 mg/kg qw. Under country-specific provisions (UK only), participants could be considered for a further dose escalation to 7.5 mg/kg qw if a thorough case review indicated that a participant continued to have evidence of disease progression at a dose of 5 mg/kg qw. All dose escalations were contingent upon acceptable safety and tolerability of preceding infusions and were undertaken by mutual agreement of the Investigator and Sponsor and after approval by an independent safety committee.
Change From Baseline In Percentiles For Weight For Age (WFA) At 12, 24, And 36 Months Month 12	27.760 percentile Interval 1.34 to 67.58
Change From Baseline In Percentiles For Weight For Age (WFA) At 12, 24, And 36 Months Month 24	41.276 percentile Interval 7.54 to 63.77
Change From Baseline In Percentiles For Weight For Age (WFA) At 12, 24, And 36 Months Month 36	59.310 percentile Interval 36.39 to 72.51

SECONDARY outcome

Timeframe: Baseline to Month 12, Month 24, and Month 36

Population: FAS: All participants who received any amount of sebelipase alfa (1.0, 3.0, 5.0, or 7.5 mg/kg qw) during the study and where applicable, met end point criteria.

The number of participants who met criteria for the following 3 dichotomous indicators of under nutrition were reported. These indicators included the following:

1. Stunting was defined as at least 2 standard deviations below the median for length-for-age/height-for-age.

2. Wasting was defined as wasting at least 2 standard deviations below the median for weight-for-length/weight-for-height.

3. Underweight was defined as at least 2 standard deviations below the median for WFA.

Outcome measures

Measure	Open-Label Sebelipase Alfa n=10 Participants All participants initiated qw IV infusions with sebelipase alfa at a dose of 1 mg/kg qw. A participant who met protocol defined dose escalation criteria at a dose of 1 mg/kg qw could be considered for a dose escalation to 3 mg/kg qw. If a participant continued to meet dose escalation criteria after at least 4 infusions at a dose of 3 mg/kg qw, the participant could be considered for a further dose escalation to 5 mg/kg qw. Under country-specific provisions (UK only), participants could be considered for a further dose escalation to 7.5 mg/kg qw if a thorough case review indicated that a participant continued to have evidence of disease progression at a dose of 5 mg/kg qw. All dose escalations were contingent upon acceptable safety and tolerability of preceding infusions and were undertaken by mutual agreement of the Investigator and Sponsor and after approval by an independent safety committee.
Number Of Participants With Stunting, Wasting, Or Underweight At Baseline, 12, 24, And 36 Months Stunting, Baseline	4 Participants
Number Of Participants With Stunting, Wasting, Or Underweight At Baseline, 12, 24, And 36 Months Stunting, Month 12	0 Participants
Number Of Participants With Stunting, Wasting, Or Underweight At Baseline, 12, 24, And 36 Months Stunting, Month 24	0 Participants
Number Of Participants With Stunting, Wasting, Or Underweight At Baseline, 12, 24, And 36 Months Stunting, Month 36	0 Participants
Number Of Participants With Stunting, Wasting, Or Underweight At Baseline, 12, 24, And 36 Months Wasting, Baseline	5 Participants
Number Of Participants With Stunting, Wasting, Or Underweight At Baseline, 12, 24, And 36 Months Wasting, Month 12	0 Participants
Number Of Participants With Stunting, Wasting, Or Underweight At Baseline, 12, 24, And 36 Months Wasting, Month 24	0 Participants
Number Of Participants With Stunting, Wasting, Or Underweight At Baseline, 12, 24, And 36 Months Wasting, Month 36	0 Participants
Number Of Participants With Stunting, Wasting, Or Underweight At Baseline, 12, 24, And 36 Months Underweight, Baseline	6 Participants
Number Of Participants With Stunting, Wasting, Or Underweight At Baseline, 12, 24, And 36 Months Underweight, Month 12	0 Participants
Number Of Participants With Stunting, Wasting, Or Underweight At Baseline, 12, 24, And 36 Months Underweight, Month 24	0 Participants
Number Of Participants With Stunting, Wasting, Or Underweight At Baseline, 12, 24, And 36 Months Underweight, Month 36	0 Participants

SECONDARY outcome

Timeframe: Baseline, Month 12, Month 24, and Month 36

Population: FAS: All participants who received any amount of sebelipase alfa (1.0, 3.0, 5.0, or 7.5 mg/kg qw) during the study and where applicable, met end point criteria.

This outcome measure evaluated the effects of sebelipase alfa on liver function by measuring the change from baseline in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) at months 12, 24, and 36. Results are reported in units/liter (U/L).

Outcome measures

Measure	Open-Label Sebelipase Alfa n=10 Participants All participants initiated qw IV infusions with sebelipase alfa at a dose of 1 mg/kg qw. A participant who met protocol defined dose escalation criteria at a dose of 1 mg/kg qw could be considered for a dose escalation to 3 mg/kg qw. If a participant continued to meet dose escalation criteria after at least 4 infusions at a dose of 3 mg/kg qw, the participant could be considered for a further dose escalation to 5 mg/kg qw. Under country-specific provisions (UK only), participants could be considered for a further dose escalation to 7.5 mg/kg qw if a thorough case review indicated that a participant continued to have evidence of disease progression at a dose of 5 mg/kg qw. All dose escalations were contingent upon acceptable safety and tolerability of preceding infusions and were undertaken by mutual agreement of the Investigator and Sponsor and after approval by an independent safety committee.
Change From Baseline In Serum Transaminases (ALT And AST) At Month 12, 24, And 36 ALT: Month 12	0 U/L Interval -175.0 to 66.0
Change From Baseline In Serum Transaminases (ALT And AST) At Month 12, 24, And 36 ALT: Month 24	14.0 U/L Interval -207.0 to 80.0
Change From Baseline In Serum Transaminases (ALT And AST) At Month 12, 24, And 36 ALT: Month 36	-42.0 U/L Interval -224.0 to 6.0
Change From Baseline In Serum Transaminases (ALT And AST) At Month 12, 24, And 36 AST: Month 12	-33.5 U/L Interval -322.0 to 8.0
Change From Baseline In Serum Transaminases (ALT And AST) At Month 12, 24, And 36 AST: Month 24	-4.0 U/L Interval -90.0 to 36.0
Change From Baseline In Serum Transaminases (ALT And AST) At Month 12, 24, And 36 AST: Month 36	-101.0 U/L Interval -351.0 to -9.0

SECONDARY outcome

Timeframe: Baseline, Month 12, Month 24, and Month 36

Population: FAS: All participants who received any amount of sebelipase alfa (1.0, 3.0, 5.0, or 7.5 mg/kg qw) during the study and where applicable, met end point criteria.

The median change in the inflammatory marker serum ferritin from Baseline to Months 12, 24, and 36 is presented. The number of participants analyzed reflects only those from the FAS who had both a baseline value and a value at the indicated timepoint (Months 12, 24, and 36). Results are reported in micrograms (ug)/L.

Outcome measures

Measure	Open-Label Sebelipase Alfa n=2 Participants All participants initiated qw IV infusions with sebelipase alfa at a dose of 1 mg/kg qw. A participant who met protocol defined dose escalation criteria at a dose of 1 mg/kg qw could be considered for a dose escalation to 3 mg/kg qw. If a participant continued to meet dose escalation criteria after at least 4 infusions at a dose of 3 mg/kg qw, the participant could be considered for a further dose escalation to 5 mg/kg qw. Under country-specific provisions (UK only), participants could be considered for a further dose escalation to 7.5 mg/kg qw if a thorough case review indicated that a participant continued to have evidence of disease progression at a dose of 5 mg/kg qw. All dose escalations were contingent upon acceptable safety and tolerability of preceding infusions and were undertaken by mutual agreement of the Investigator and Sponsor and after approval by an independent safety committee.
Change From Baseline In Serum Ferritin At Month 12, 24, And 36 Month 12	-2957.00 ug/L Interval -2957.0 to -2957.0
Change From Baseline In Serum Ferritin At Month 12, 24, And 36 Month 24	-1722.00 ug/L Interval -2984.0 to -460.0

SECONDARY outcome

Timeframe: Baseline through Month 36

Population: FAS: All participants who received any amount of sebelipase alfa (1.0, 3.0, 5.0, or 7.5 mg/kg qw) during the study and where applicable, met end point criteria.

The number of participants achieving and maintaining TFHN are presented. For TFHN to be achieved, the participant had to meet the following criteria:

1. Two post baseline measurements of hemoglobin, at least 4 weeks apart, were above the age-adjusted lower limit of normal (LLN);

2. No known additional measurements of hemoglobin were below the age-adjusted LLN during the (minimum) 4 week period;

3. No transfusions were administered to the participant during the (minimum) 4 week period, or for 2 weeks prior to the first hemoglobin measurement in the (minimum) 4 week period. If all 3 criteria were met, a participant was considered to have achieved TFHN on the date of the first hemoglobin assessment in the 4 week period. A participant was considered to have maintained TFHN if he/she was transfusion free at Week 6 and had no abnormally low hemoglobin levels (levels below the age adjusted LLN) beginning at Week 8 of the study and continuing for at least 13 weeks (3 months).

Outcome measures

Measure	Open-Label Sebelipase Alfa n=10 Participants All participants initiated qw IV infusions with sebelipase alfa at a dose of 1 mg/kg qw. A participant who met protocol defined dose escalation criteria at a dose of 1 mg/kg qw could be considered for a dose escalation to 3 mg/kg qw. If a participant continued to meet dose escalation criteria after at least 4 infusions at a dose of 3 mg/kg qw, the participant could be considered for a further dose escalation to 5 mg/kg qw. Under country-specific provisions (UK only), participants could be considered for a further dose escalation to 7.5 mg/kg qw if a thorough case review indicated that a participant continued to have evidence of disease progression at a dose of 5 mg/kg qw. All dose escalations were contingent upon acceptable safety and tolerability of preceding infusions and were undertaken by mutual agreement of the Investigator and Sponsor and after approval by an independent safety committee.
Number Of Participants Achieving And Maintaining Transfusion-free Hemoglobin Normalization (TFHN) Achieved TFHN	7 Participants
Number Of Participants Achieving And Maintaining Transfusion-free Hemoglobin Normalization (TFHN) Maintained TFHN	0 Participants

Adverse Events

Sebelipase Alfa: 1.0 mg/kg qw

Serious events: 8 serious events

Other events: 9 other events

Deaths: 1 deaths

Sebelipase Alfa: 3.0 mg/kg qw

Serious events: 8 serious events

Other events: 9 other events

Deaths: 0 deaths

Sebelipase Alfa: 5.0 mg/kg qw

Serious events: 7 serious events

Other events: 7 other events

Deaths: 1 deaths

Sebelipase Alfa: 7.5 mg/kg qw

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sebelipase Alfa: 1.0 mg/kg qw n=10 participants at risk This reporting group is based on the FAS and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 1.0 mg/kg qw. All 10 participants in the FAS received sebelipase alfa at a dose of 1.0 mg/kg qw.	Sebelipase Alfa: 3.0 mg/kg qw n=9 participants at risk This reporting group is based on the FAS and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 3.0 mg/kg qw. Nine of the 10 participants in the FAS received sebelipase alfa at a dose of 3.0 mg/kg qw.	Sebelipase Alfa: 5.0 mg/kg qw n=7 participants at risk This reporting group is based on the FAS and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 5.0 mg/kg qw. Seven of the 10 participants in the FAS received sebelipase alfa at a dose of 5.0 mg/kg qw.	Sebelipase Alfa: 7.5 mg/kg qw n=1 participants at risk This reporting group is based on the FAS and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 7.5 mg/kg qw (UK only). One of the 10 participants in the FAS received sebelipase alfa at a dose of 7.5 mg/kg qw.
Blood and lymphatic system disorders Abdominal lymphadenopathy	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Blood and lymphatic system disorders Histiocytosis haematophagic	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Cardiac disorders Tachycardia	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 5 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Cardiac disorders Pericardial effusion	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Cardiac disorders Sinus bradycardia	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Vomiting	10.0% 1/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	55.6% 5/9 • Number of events 8 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	57.1% 4/7 • Number of events 8 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Diarrhoea	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	44.4% 4/9 • Number of events 6 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Colitis	10.0% 1/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Abdominal distension	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Gastritis	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Intestinal obstruction	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Lip swelling	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Malabsorption	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Tongue erythema	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Pyrexia	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	66.7% 6/9 • Number of events 12 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	42.9% 3/7 • Number of events 4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	100.0% 1/1 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Catheter site haemorrhage	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Complication associated with device	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Hypothermia	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Hepatobiliary disorders Liver disorder	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Immune system disorders Anaphylactic reaction	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Gastroenteritis	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	66.7% 6/9 • Number of events 7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	42.9% 3/7 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Sepsis	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Upper respiratory tract infection	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	33.3% 3/9 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Device related sepsis	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	42.9% 3/7 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Device related infection	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Viral upper respiratory tract infection	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Gastroenteritis norovirus	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Stoma site infection	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Influenza	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Cellulitis	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Gastroenteritis rotavirus	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Gastroenteritis viral	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Parainfluenzae virus infection	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Rhinovirus infection	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Tonsillitis	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Otitis media	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 5 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Respiratory tract infection viral	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	100.0% 1/1 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Bronchitis	10.0% 1/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Catheter site infection	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Gastritis viral	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Abscess bacterial	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Croup infectious	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Ear infection	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Escherichia sepsis	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Gastroenteritis adenovirus	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Lice infestation	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Lower respiratory tract infection	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Respiratory syncytial virus infection	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Respiratory tract infection	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Scrotal infection	0.00% 0/5 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/5 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	25.0% 1/4 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	— 0/0 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Staphylococcal skin infection	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Tonsillitis streptococcal	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Injury, poisoning and procedural complications Skull fracture	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Injury, poisoning and procedural complications Subdural haematoma	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Injury, poisoning and procedural complications Transfusion reaction	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Drug specific antibody present	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Body temperature fluctuation	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Body temperature increased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Sapovirus test positive	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Weight decreased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Feeding disorder	10.0% 1/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	33.3% 3/9 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Dehydration	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Malnutrition	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Product Issues Device occlusion	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Product Issues Embedded device	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Psychiatric disorders Agitation	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Psychiatric disorders Irritability	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Renal and urinary disorders Nephrotic syndrome	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Renal and urinary disorders Oliguria	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Respiratory distress	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Hypoxia	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Urticaria	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Surgical and medical procedures Bone marrow transplant	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	100.0% 1/1 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Vascular disorders Poor venous access	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Vascular disorders Bloody discharge	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Vascular disorders Flushing	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Vascular disorders Hypotension	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Vascular disorders Superior vena cava occlusion	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Vascular disorders Venoocclusive disease	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).

Other adverse events

Measure	Sebelipase Alfa: 1.0 mg/kg qw n=10 participants at risk This reporting group is based on the FAS and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 1.0 mg/kg qw. All 10 participants in the FAS received sebelipase alfa at a dose of 1.0 mg/kg qw.	Sebelipase Alfa: 3.0 mg/kg qw n=9 participants at risk This reporting group is based on the FAS and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 3.0 mg/kg qw. Nine of the 10 participants in the FAS received sebelipase alfa at a dose of 3.0 mg/kg qw.	Sebelipase Alfa: 5.0 mg/kg qw n=7 participants at risk This reporting group is based on the FAS and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 5.0 mg/kg qw. Seven of the 10 participants in the FAS received sebelipase alfa at a dose of 5.0 mg/kg qw.	Sebelipase Alfa: 7.5 mg/kg qw n=1 participants at risk This reporting group is based on the FAS and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 7.5 mg/kg qw (UK only). One of the 10 participants in the FAS received sebelipase alfa at a dose of 7.5 mg/kg qw.
Gastrointestinal disorders Vomiting	50.0% 5/10 • Number of events 11 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	66.7% 6/9 • Number of events 15 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	57.1% 4/7 • Number of events 11 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Diarrhoea	40.0% 4/10 • Number of events 12 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	55.6% 5/9 • Number of events 23 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	71.4% 5/7 • Number of events 29 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Teething	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	33.3% 3/9 • Number of events 5 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Constipation	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 5 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Abdominal distension	20.0% 2/10 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Abdominal pain	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	100.0% 1/1 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 6 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Gastritis	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Abdominal discomfort	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Aphthous ulcer	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Chapped lips	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Faeces hard	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Flatulence	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Gastrooesophageal reflux disease	10.0% 1/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Haematemesis	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Infantile spitting up	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Inguinal hernia	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Lip dry	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Lip swelling	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Pyrexia	70.0% 7/10 • Number of events 15 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	77.8% 7/9 • Number of events 43 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	71.4% 5/7 • Number of events 36 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	100.0% 1/1 • Number of events 5 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Pain	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Catheter site erythema	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Mucosal inflammation	10.0% 1/10 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	42.9% 3/7 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Oedema peripheral	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Catheter site discharge	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Catheter site extravasation	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Catheter site granuloma	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Catheter site swelling	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Complication associated with device	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Face oedema	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Hypothermia	10.0% 1/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Catheter site bruise	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Crying	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Feeling cold	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Hypertrophy	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Inflammation	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Injection site erythema	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Mass	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Oedema	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	100.0% 1/1 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Swelling	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Vaccination site pain	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
General disorders Vessel puncture site discharge	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Blood and lymphatic system disorders Anaemia	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	100.0% 1/1 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Blood and lymphatic system disorders Lymphadenopathy	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Blood and lymphatic system disorders Neutropenia	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Blood and lymphatic system disorders Hypochromasia	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Blood and lymphatic system disorders Iron deficiency anaemia	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Blood and lymphatic system disorders Leukocytosis	10.0% 1/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Blood and lymphatic system disorders Leukopenia	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Blood and lymphatic system disorders Lymph node calcification	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Blood and lymphatic system disorders Lymphocytosis	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Blood and lymphatic system disorders Microcytosis	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Blood and lymphatic system disorders Neutrophilia	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Blood and lymphatic system disorders Thrombocytopenia	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Device related infection	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	44.4% 4/9 • Number of events 5 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 5 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	100.0% 1/1 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Device related sepsis	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Rhinitis	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	44.4% 4/9 • Number of events 8 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Sepsis	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	44.4% 4/9 • Number of events 4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	100.0% 1/1 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Nasopharyngitis	10.0% 1/10 • Number of events 4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Upper respiratory tract infection	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	42.9% 3/7 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Rhinovirus infection	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Viral upper respiratory tract infection	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Candida infection	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Gastroenteritis	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Lower respiratory tract infection	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Parainfluenza virus infection	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Respiratory tract infection viral	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Staphylococcal infection	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Stoma site infection	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Tonsillitis	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Abscess limb	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Adenoviral upper respiratory infection	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Adenovirus infection	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Bacteraemia	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	100.0% 1/1 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Candida nappy rash	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Catheter site abscess	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Ctyomegalovirus viraemia	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Enterococcal infection	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Escherichia urinary tract infection	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Exanthema subitum	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Eye infection	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Eye infection bacterial	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Fungal infection	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Gastroenteritis norovirus	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Gastroenteritis rotavirus	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Gastroenteritis sapovirus	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Hordeolum	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Influenza	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Oral candidiasis	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Otitis media	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Parechovirus infection	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Pneumonia	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Respiratory tract infection	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Skin infection	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Urinary tract infection	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Infections and infestations Viral infection	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Respiratory rate increased	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood calcium decreased	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Body temperature increased	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Heart rate increased	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Liver function test abnormal	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Protein total decreased	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Serum ferritin increased	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Vitamin D decreased	30.0% 3/10 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Vitamin E decreased	20.0% 2/10 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood albumin decreased	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood cholesterol increased	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood lactate dehydrogenase increased	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood potassium decreased	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood pressure increased	10.0% 1/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood triglycerides increased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Body temperature abnormal	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Drug specific antibody present	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	100.0% 1/1 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Alanine aminotransferase increased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Alpha 1 foetoprotein increased	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Alpha-1 anti-trypsin increased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Antibody test positive	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Aspartate aminotransferase increased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Bacterial test positive	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Beta-2 glycoprotein antibody	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood aldosterone decreased	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood aldosterone increased	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood alkaline phosphatase decreased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood fibrinogen decreased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood fibrinogen increased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood glucose fluctuation	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood glucose increased	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood iron decreased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood parathyroid hormone	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood pressure abnormal	10.0% 1/10 • Number of events 4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood sodium decreased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood triglycerides decreased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood urea decreased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood urea increased	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Blood uric acid decreased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Body temperature	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Body temperature decreased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Brucella test positive	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations C-reactive protein increased	10.0% 1/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 5 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Cardiac murmur	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Cortisol increased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Drug specific antibody	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Faecal calprotectin increased	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Fibrin D dimer increased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Gamma-glutamyltransferase increased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Gastric fluid analysis abnormal	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations High density lipoprotein decreased	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Human rhinovirus test positive	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Low density lipoprotein increased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Nasogastric output abnormal	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Neutrophil count increased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Nitrite urine present	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Norovirus test positive	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Osmolar gap increased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Oxygen saturation decreased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Parvovirus B19 test positive	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Procalcitonin increased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Prothrombin level decreased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Prothrombin time prolonged	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Renal function test abnormal	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Renin decreased	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Renin increased	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Staphylococcus test positive	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Transaminases increased	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Vitamin A decreased	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Investigations Weight decreased	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	33.3% 3/9 • Number of events 4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Hypoalbuminaemia	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Hypokalaemia	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Hyponatraemia	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Hypovitaminosis	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Vitamin D deficiency	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Dehydration	20.0% 2/10 • Number of events 4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Electrolyte imbalance	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Feeding disorder	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Fluid overload	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Hypophagia	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Hypophosphataemia	10.0% 1/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Hyposideraemia	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Iron deficiency	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Metabolic acidosis	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Vitamin A deficiency	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Vitamin E deficiency	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Product Issues Device occlusion	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	33.3% 3/9 • Number of events 4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	57.1% 4/7 • Number of events 4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Product Issues Device dislocation	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Product Issues Device breakage	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Product Issues Device infusion issue	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Cough	30.0% 3/10 • Number of events 6 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	44.4% 4/9 • Number of events 19 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	57.1% 4/7 • Number of events 8 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	33.3% 3/9 • Number of events 6 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	57.1% 4/7 • Number of events 6 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Nasal congestion	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	33.3% 3/9 • Number of events 5 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Respiratory distress	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	42.9% 3/7 • Number of events 8 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Wheezing	10.0% 1/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	42.9% 3/7 • Number of events 6 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	33.3% 3/9 • Number of events 4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Sneezing	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Use of accessory respiratory muscles	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Nasal oedema	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Tonsillar erythema	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Dermatitis diaper	30.0% 3/10 • Number of events 5 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	33.3% 3/9 • Number of events 9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	42.9% 3/7 • Number of events 4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Pruritus	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	100.0% 1/1 • Number of events 5 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Rash	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Dry skin	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Eczema	10.0% 1/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Pigmentation disorder	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Skin disorder	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	100.0% 1/1 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Urticaria	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Rash maculo-papular	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Alopecia	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Erythema	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Hyperhidrosis	10.0% 1/10 • Number of events 5 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Red man syndrome	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Scar pain	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Skin irritation	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Cardiac disorders Tachycardia	50.0% 5/10 • Number of events 8 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	66.7% 6/9 • Number of events 13 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	42.9% 3/7 • Number of events 5 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	100.0% 1/1 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Cardiac disorders Bradycardia	30.0% 3/10 • Number of events 4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Cardiac disorders Cardiac septal hypertrophy	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Cardiac disorders Cardiomyopathy	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Cardiac disorders Cyanosis	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Cardiac disorders Left ventricular dilatation	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Vascular disorders Hypertension	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	100.0% 1/1 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Vascular disorders Hypotension	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Vascular disorders Hyperaemia	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Vascular disorders Lymphodema	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Vascular disorders Microangiopathy	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Vascular disorders Poor venous access	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Vascular disorders Superior vena cava occlusion	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Injury, poisoning and procedural complications Stoma site erythema	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Injury, poisoning and procedural complications Contusion	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Injury, poisoning and procedural complications Fall	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Injury, poisoning and procedural complications Head injury	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Injury, poisoning and procedural complications Procedural pain	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Injury, poisoning and procedural complications Stoma site hypergranulation	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Injury, poisoning and procedural complications Drug administration error	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Injury, poisoning and procedural complications Gastrostomy tube site complication	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Injury, poisoning and procedural complications Laceration	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Injury, poisoning and procedural complications Overdose	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Injury, poisoning and procedural complications Scar	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Injury, poisoning and procedural complications Stoma site extravasation	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Injury, poisoning and procedural complications Stoma site haemorrhage	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Eye disorders Eyelid oedema	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Eye disorders Eye discharge	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	28.6% 2/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Eye disorders Eyelid rash	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Eye disorders Ocular hyperaemia	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Psychiatric disorders Irritability	30.0% 3/10 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	44.4% 4/9 • Number of events 5 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Psychiatric disorders Agitation	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	100.0% 1/1 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Psychiatric disorders Restlessness	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Psychiatric disorders Drug abuse	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Psychiatric disorders Staring	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Psychiatric disorders Stress	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Renal and urinary disorders Proteinuria	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Renal and urinary disorders Renal impairment	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Renal and urinary disorders Urinary retention	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Congenital, familial and genetic disorders Atrial septal defect	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Congenital, familial and genetic disorders Chimerism	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Congenital, familial and genetic disorders Chromosomal deletion	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Congenital, familial and genetic disorders Hydrocele	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Immune system disorders Hypersensitivity	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	22.2% 2/9 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Immune system disorders Allergy to animal	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Immune system disorders Anaphylactic reaction	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Immune system disorders Drug hypersensitivity	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Hepatobiliary disorders Hepatic calcification	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Hepatobiliary disorders Cholelithiasis	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Musculoskeletal and connective tissue disorders Joint swelling	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Nervous system disorders Petit mal epilepsy	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Nervous system disorders Somnolence	10.0% 1/10 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/9 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/5 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	33.3% 1/3 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Gastrointestinal disorders Intestinal obstruction	0.00% 0/10 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Hypoglycaemia	20.0% 2/10 • Number of events 2 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	14.3% 1/7 • Number of events 4 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).
Metabolism and nutrition disorders Malnutrition	20.0% 2/10 • Number of events 3 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	11.1% 1/9 • Number of events 1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/7 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).	0.00% 0/1 • Screening (up to 21 days prior to start of treatment) to Month 37 (approximately 30 days after the last dose of study drug).

Additional Information

Alexion Pharmaceuticals Inc.

Alexion Pharmaceuticals Inc.

Phone: 855-752-2356

Email: clinicaltrials@alexion.com

Results disclosure agreements

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