Trial Outcomes & Findings for Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) (NCT NCT00116688)

NCT ID: NCT00116688

Last Updated: 2013-12-18

Results Overview

Participants with one or more occurrences of one or more adverse events up to 8 weeks after the end of treatment. Participants with more than one event were only counted once.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 313 participants
• Primary outcome timeframe: Duration of treatment plus 8 weeks (up to 285 weeks)
• Results posted on: 2013-12-18

Participant Flow

Participants were enrolled from 2 August 2004 through 15 April 2009

Participant milestones

Measure	Romiplostim in Adults Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving \>10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to \>10 µg/kg.	Romiplostim in Pediatric Population Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
Overall Study STARTED	292	21
Overall Study Received Study Medication	291	20
Overall Study COMPLETED	200	17
Overall Study NOT COMPLETED	92	4

Reasons for withdrawal

Measure	Romiplostim in Adults Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving \>10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to \>10 µg/kg.	Romiplostim in Pediatric Population Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
Overall Study Protocol deviation	1	0
Overall Study Noncompliance	3	1
Overall Study Adverse Event	11	0
Overall Study Withdrawal by Subject	26	2
Overall Study Requirement for alternative therapy	11	1
Overall Study Physician Decision	7	0
Overall Study Lost to Follow-up	3	0
Overall Study Death	15	0
Overall Study Protocol-specified criteria	3	0
Overall Study Pregnancy	1	0
Overall Study Other	11	0

Baseline Characteristics

Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Baseline characteristics by cohort

Measure	Romiplostim in Adults n=292 Participants Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving \>10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to \>10 µg/kg.	Romiplostim in Pediatric Population n=21 Participants Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.	Total n=313 Participants Total of all reporting groups
Age, Continuous	54.2 Years STANDARD_DEVIATION 16.9 • n=5 Participants	10.2 Years STANDARD_DEVIATION 5.1 • n=7 Participants	51.3 Years STANDARD_DEVIATION 19.7 • n=5 Participants
Sex: Female, Male Female	184 Participants n=5 Participants	6 Participants n=7 Participants	190 Participants n=5 Participants
Sex: Female, Male Male	108 Participants n=5 Participants	15 Participants n=7 Participants	123 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	13 Participants n=5 Participants	3 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	246 Participants n=5 Participants	13 Participants n=7 Participants	259 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	21 Participants n=5 Participants	4 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Asian	9 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Duration of treatment plus 8 weeks (up to 285 weeks)

Population: Safety Analysis Set, composed of all participants who received at least one dose of romiplostim

Participants with one or more occurrences of one or more adverse events up to 8 weeks after the end of treatment. Participants with more than one event were only counted once.

Outcome measures

Measure	Romiplostim in Adults n=291 Participants Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving \>10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to \>10 µg/kg.	Romiplostim in Pediatric Population n=20 Participants Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
Number of Participants With Adverse Events	284 Participants	19 Participants

SECONDARY outcome

Timeframe: Duration of treatment (up to 277 weeks)

Population: Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim

Platelet response was defined as having a platelet count of ≥ 50 x 10^9/L at any time on study, excluding platelet counts within 8 weeks after receiving any rescue medications.

Outcome measures

Measure	Romiplostim in Adults n=291 Participants Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving \>10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to \>10 µg/kg.	Romiplostim in Pediatric Population n=20 Participants Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
Number of Participants With a Platelet Response	275 Participants	20 Participants

SECONDARY outcome

Timeframe: Duration of treatment (up to 277 weeks)

Population: Subset of Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim and with baseline concurrent ITP therapy.

The number of participants with a reduction or discontinuation of concurrent immune (idiopathic) thrombocytopenic purpura (ITP) therapies (corticosteroids, danazol, azathioprine) during the study.

Outcome measures

Measure	Romiplostim in Adults n=37 Participants Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving \>10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to \>10 µg/kg.	Romiplostim in Pediatric Population n=2 Participants Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
Number of Participants With a Reduction or Discontinuation of Concurrent ITP Therapies	30 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.

The ITP Patient Assessment Questionnaire (ITP-PAQ) assesses ITP-specific health-related quality of life (HRQOL). This questionnaire assesses ITP specific health-related quality of life (HRQOL). The questionnaire consists of 44 items and has six domains: These domains assess the impact of ITP on Physical Health, Mental Health, Work, Social Activity, Women's Health and Overall QOL. The impact of ITP on Physical Health consists of four sub-scales, which evaluate ITP related Symptoms, Fatigue, Bother and Activity. The impact of ITP on Mental Health consists of two sub-scales, which evaluate Psychological distress and Fear in a population with ITP. Items are scored from 0-100 with higher scores indicating better HRQOL.

Outcome measures

Measure	Romiplostim in Adults n=292 Participants Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving \>10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to \>10 µg/kg.	Romiplostim in Pediatric Population Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
Change From Baseline in ITP Patient Assessment Questionnaire Physical Health Fatigue (N=208)	3.99 scores on a scale Standard Deviation 16.00	—
Change From Baseline in ITP Patient Assessment Questionnaire Physical Health Activity (N=208)	5.23 scores on a scale Standard Deviation 21.08	—
Change From Baseline in ITP Patient Assessment Questionnaire Emotional Health Psychological (N=208)	4.01 scores on a scale Standard Deviation 15.81	—
Change From Baseline in ITP Patient Assessment Questionnaire Emotional Health Fear (N=209)	3.48 scores on a scale Standard Deviation 12.59	—
Change From Baseline in ITP Patient Assessment Questionnaire Physical Health Symptoms (N=209)	4.20 scores on a scale Standard Deviation 13.15	—
Change From Baseline in ITP Patient Assessment Questionnaire Physical Health Bother (N=204)	6.43 scores on a scale Standard Deviation 17.39	—
Change From Baseline in ITP Patient Assessment Questionnaire Overall Quality of Life (N=210)	8.32 scores on a scale Standard Deviation 19.65	—
Change From Baseline in ITP Patient Assessment Questionnaire Social Quality of Life (N=209)	3.89 scores on a scale Standard Deviation 13.41	—
Change From Baseline in ITP Patient Assessment Questionnaire Women's Reproductive Health (N=71)	4.51 scores on a scale Standard Deviation 16.35	—
Change From Baseline in ITP Patient Assessment Questionnaire Work Quality of Life (N=75)	2.78 scores on a scale Standard Deviation 14.54	—

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.

The SF-36 is a widely used generic health-related quality of life measure. It has 36 questions with 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Items are scored from 0 to 100 with higher scores indicating better health status.

Outcome measures

Measure	Romiplostim in Adults n=292 Participants Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving \>10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to \>10 µg/kg.	Romiplostim in Pediatric Population Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
Change From Baseline in Short Form 36 (SF-36) Physical Component Summary (N=200)	1.49 scores on a scale Standard Deviation 6.51	—
Change From Baseline in Short Form 36 (SF-36) Mental Component Summary (N=200)	1.06 scores on a scale Standard Deviation 8.80	—
Change From Baseline in Short Form 36 (SF-36) Physical Functioning (N=206)	1.38 scores on a scale Standard Deviation 6.34	—
Change From Baseline in Short Form 36 (SF-36) Role-Physical (N=208)	2.03 scores on a scale Standard Deviation 8.89	—
Change From Baseline in Short Form 36 (SF-36) Bodily Pain (N=206)	0.94 scores on a scale Standard Deviation 7.99	—
Change From Baseline in Short Form 36 (SF-36) Role-Emotional (N=205)	1.75 scores on a scale Standard Deviation 12.22	—
Change From Baseline in Short Form 36 (SF-36) General Health Perception (N=208)	1.31 scores on a scale Standard Deviation 7.03	—
Change From Baseline in Short Form 36 (SF-36) Vitality (N=208)	1.68 scores on a scale Standard Deviation 7.47	—
Change From Baseline in Short Form 36 (SF-36) Social Functioning (N=208)	0.52 scores on a scale Standard Deviation 8.21	—
Change From Baseline in Short Form 36 (SF-36) Mental Health Index (N=208)	0.91 scores on a scale Standard Deviation 7.45	—

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.

The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The instrument is applicable to a wide range of health conditions and treatments and results in a single index score and a visual analog scale (VAS) score. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state is defined by combining one level from each of the five dimensions. EQ-5D index values range from -0.59 to 1.00. Higher EQ-5D Index scores represent better health status.

Outcome measures

Measure	Romiplostim in Adults n=154 Participants Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving \>10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to \>10 µg/kg.	Romiplostim in Pediatric Population Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
Change From Baseline in Euroqol-5D (EQ-5D) Index Score	0.03 scores on a scale Standard Deviation 0.16	—

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.

The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The EQ-5D VAS records the respondent's self-rated health status on a vertical graduated (0-100) visual analogue scale. Higher EQ-5D VAS scores represent better health status.

Outcome measures

Measure	Romiplostim in Adults n=150 Participants Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving \>10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to \>10 µg/kg.	Romiplostim in Pediatric Population Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
Change From Baseline in Euroqol-5D (EQ-5D) Visual Analogue Scale (VAS)	6.05 scores on a scale Standard Deviation 14.85	—

SECONDARY outcome

Timeframe: Week 1 and Week 48

Population: Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.

The Patient Global Assessment is two questions which assess the overall health-related quality of life (HRQOL) and symptoms of the patient. Each item is answered on a 15-point Likert scale ranging from 'A very great deal worse' (1) to 'A very great deal better' (15). A higher score indicates that quality of life or symptoms have improved.

Outcome measures

Measure	Romiplostim in Adults n=292 Participants Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving \>10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to \>10 µg/kg.	Romiplostim in Pediatric Population Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
Patient Global Assessment Week 48 (N=216)	8.18 scores on a scale Standard Deviation 1.78	—
Patient Global Assessment Week 1 (N=271)	7.61 scores on a scale Standard Deviation 2.02	—

Adverse Events

Romiplostim in Adults

Serious events: 117 serious events

Other events: 270 other events

Deaths: 0 deaths

Romiplostim in Pediatric Population

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Romiplostim in Adults n=291 participants at risk Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving \>10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to \>10 µg/kg.	Romiplostim in Pediatric Population n=20 participants at risk Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Blood and lymphatic system disorders Anaemia	1.0% 3/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Blood and lymphatic system disorders Bicytopenia	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Blood and lymphatic system disorders Bone marrow disorder	1.4% 4/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Blood and lymphatic system disorders Bone marrow reticulin fibrosis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Blood and lymphatic system disorders Evans syndrome	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Blood and lymphatic system disorders Haemolytic anaemia	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Blood and lymphatic system disorders Idiopathic thrombocytopenic purpura	2.4% 7/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	5.0% 1/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Blood and lymphatic system disorders Leukocytosis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Blood and lymphatic system disorders Neutropenia	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Blood and lymphatic system disorders Thrombocytopenia	7.9% 23/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Cardiac disorders Acute myocardial infarction	1.0% 3/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Cardiac disorders Angina unstable	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Cardiac disorders Atrial fibrillation	1.0% 3/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Cardiac disorders Cardiac arrest	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Cardiac disorders Cardiac failure	1.4% 4/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Cardiac disorders Cardiac failure congestive	1.7% 5/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Cardiac disorders Cardiac tamponade	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Cardiac disorders Coronary artery disease	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Cardiac disorders Myocardial infarction	1.7% 5/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Cardiac disorders Pericardial haemorrhage	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Cardiac disorders Trifascicular block	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Congenital, familial and genetic disorders Atrial septal defect	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Ear and labyrinth disorders Vertigo	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Ear and labyrinth disorders Vestibular disorder	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Eye disorders Blindness	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Eye disorders Conjunctival haemorrhage	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Eye disorders Papilloedema	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Abdominal distension	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Abdominal pain	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Abdominal pain lower	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Abdominal pain upper	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Anal fistula	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Ascites	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Colitis	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Colitis ischaemic	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Diarrhoea	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Dyspepsia	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Femoral hernia	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.4% 4/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Gingival bleeding	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Haematemesis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Irritable bowel syndrome	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Mouth cyst	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Mouth haemorrhage	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Mouth ulceration	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Nausea	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Periodontitis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Rectal haemorrhage	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Small intestinal obstruction	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Tooth impacted	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Tooth loss	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Vomiting	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Adverse drug reaction	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Asthenia	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Chest pain	1.0% 3/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Death	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Fatigue	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Generalised oedema	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Hernia	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Hernia obstructive	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Hernia pain	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Hyperpyrexia	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Mechanical complication of implant	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Oedema peripheral	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Pyrexia	1.4% 4/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Hepatobiliary disorders Biliary colic	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Hepatobiliary disorders Cholecystitis	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Hepatobiliary disorders Cholecystitis acute	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Hepatobiliary disorders Cholelithiasis	1.0% 3/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Hepatobiliary disorders Hepatic failure	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Hepatobiliary disorders Hepatic steatosis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Hepatobiliary disorders Hepatitis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Hepatobiliary disorders Portal vein thrombosis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Anal abscess	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Appendicitis	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Bacteraemia	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Bronchitis	1.0% 3/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Candidiasis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Catheter bacteraemia	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Catheter related infection	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Cellulitis	1.0% 3/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Device related infection	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Epiglottitis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Gastroenteritis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Haematoma infection	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Influenza	0.00% 0/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	5.0% 1/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Klebsiella sepsis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Localised infection	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Meningitis listeria	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Nasopharyngitis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Parotitis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Pharyngitis streptococcal	0.00% 0/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	5.0% 1/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Pneumococcal sepsis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Pneumonia	2.7% 8/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Pneumonia streptococcal	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Post procedural cellulitis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Progressive multifocal leukoencephalopathy	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Sepsis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Thrombophlebitis septic	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Tooth abscess	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Urosepsis	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Contusion	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Fractured sacrum	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Head injury	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Hip fracture	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Humerus fracture	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Incisional hernia	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Medical device complication	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Meniscus lesion	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Pelvic fracture	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Subdural haemorrhage	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Upper limb fracture	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Wound	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Investigations Megakaryocytes increased	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Investigations Platelet count decreased	1.0% 3/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Investigations Platelet count increased	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Metabolism and nutrition disorders Decreased appetite	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Metabolism and nutrition disorders Dehydration	1.4% 4/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Metabolism and nutrition disorders Hyperkalaemia	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Metabolism and nutrition disorders Hypokalaemia	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Musculoskeletal and connective tissue disorders Arthritis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.0% 3/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Musculoskeletal and connective tissue disorders Pain in extremity	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer recurrent	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelofibrosis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm of orbit	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Nervous system disorders Cerebrovascular accident	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Nervous system disorders Complex regional pain syndrome	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Nervous system disorders Convulsion	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Nervous system disorders Headache	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Nervous system disorders Intracranial aneurysm	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Nervous system disorders Loss of consciousness	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Nervous system disorders Migraine	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Nervous system disorders Multiple sclerosis relapse	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Nervous system disorders Presyncope	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Nervous system disorders Syncope	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Nervous system disorders Transient ischaemic attack	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Nervous system disorders Transverse sinus thrombosis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Psychiatric disorders Agitation	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Psychiatric disorders Anxiety	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Psychiatric disorders Confusional state	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Psychiatric disorders Mental status changes	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Psychiatric disorders Suicidal ideation	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Renal and urinary disorders Renal failure	1.0% 3/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Renal and urinary disorders Renal failure acute	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Renal and urinary disorders Renal failure chronic	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Renal and urinary disorders Urinary bladder polyp	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Renal and urinary disorders Urinary retention	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Reproductive system and breast disorders Menorrhagia	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Reproductive system and breast disorders Metrorrhagia	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Reproductive system and breast disorders Ovarian cyst	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Reproductive system and breast disorders Vaginal haemorrhage	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Respiratory, thoracic and mediastinal disorders Asthma	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Respiratory, thoracic and mediastinal disorders Cough	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.4% 4/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.0% 3/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	5.0% 1/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Skin and subcutaneous tissue disorders Blister	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Skin and subcutaneous tissue disorders Ecchymosis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Skin and subcutaneous tissue disorders Petechiae	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Skin and subcutaneous tissue disorders Psoriasis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Skin and subcutaneous tissue disorders Purpura	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Skin and subcutaneous tissue disorders Rash	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Skin and subcutaneous tissue disorders Systemic lupus erythematosus rash	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Skin and subcutaneous tissue disorders Urticaria	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Surgical and medical procedures Cholecystectomy	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Surgical and medical procedures Elective surgery	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Surgical and medical procedures Knee arthroplasty	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Surgical and medical procedures Plastic surgery	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Surgical and medical procedures Skin cosmetic procedure	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Surgical and medical procedures Stent placement	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Vascular disorders Aortic aneurysm	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Vascular disorders Deep vein thrombosis	0.69% 2/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Vascular disorders Femoral arterial stenosis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Vascular disorders Haematoma	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Vascular disorders Haemorrhage	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Vascular disorders Phlebitis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Vascular disorders Subgaleal haematoma	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Vascular disorders Thrombosis	0.34% 1/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.

Other adverse events

Measure	Romiplostim in Adults n=291 participants at risk Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving \>10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to \>10 µg/kg.	Romiplostim in Pediatric Population n=20 participants at risk Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
Blood and lymphatic system disorders Anaemia	5.8% 17/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	5.0% 1/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Blood and lymphatic system disorders Idiopathic thrombocytopenic purpura	10.0% 29/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	10.0% 2/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Abdominal discomfort	5.8% 17/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	5.0% 1/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Abdominal pain	11.3% 33/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	15.0% 3/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Abdominal pain upper	7.2% 21/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	20.0% 4/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Constipation	8.9% 26/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	5.0% 1/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Diarrhoea	24.7% 72/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	10.0% 2/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Dyspepsia	6.5% 19/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Gingival bleeding	14.8% 43/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	25.0% 5/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Mouth haemorrhage	7.2% 21/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	20.0% 4/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Mouth ulceration	1.4% 4/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	10.0% 2/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Nausea	23.7% 69/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	20.0% 4/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Toothache	5.8% 17/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	5.0% 1/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Gastrointestinal disorders Vomiting	15.8% 46/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	35.0% 7/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Asthenia	7.6% 22/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Chest pain	5.5% 16/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	5.0% 1/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Chills	4.1% 12/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	10.0% 2/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Fatigue	32.0% 93/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	35.0% 7/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Injection site haematoma	5.2% 15/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Oedema peripheral	14.1% 41/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Pain	11.0% 32/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	20.0% 4/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
General disorders Pyrexia	12.4% 36/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	45.0% 9/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Immune system disorders Seasonal allergy	5.5% 16/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	5.0% 1/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Bronchitis	7.6% 22/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	5.0% 1/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Ear infection	3.8% 11/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	10.0% 2/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Gastroenteritis	4.5% 13/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	10.0% 2/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Influenza	7.9% 23/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Nasopharyngitis	34.4% 100/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	25.0% 5/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Sinusitis	13.1% 38/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	5.0% 1/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Upper respiratory tract infection	26.1% 76/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	50.0% 10/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Urinary tract infection	12.4% 36/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Viral infection	1.7% 5/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	10.0% 2/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Infections and infestations Viral upper respiratory tract infection	2.4% 7/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	15.0% 3/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Animal bite	1.0% 3/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	10.0% 2/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Arthropod bite	2.1% 6/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	10.0% 2/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Contusion	30.2% 88/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	40.0% 8/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Excoriation	3.4% 10/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	15.0% 3/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Fall	6.5% 19/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Joint sprain	3.8% 11/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	10.0% 2/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Procedural pain	5.8% 17/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	10.0% 2/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Injury, poisoning and procedural complications Skin laceration	6.2% 18/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Musculoskeletal and connective tissue disorders Arthralgia	23.7% 69/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	25.0% 5/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Musculoskeletal and connective tissue disorders Back pain	18.6% 54/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	5.0% 1/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Musculoskeletal and connective tissue disorders Joint swelling	5.5% 16/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Musculoskeletal and connective tissue disorders Muscle spasms	9.6% 28/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	5.0% 1/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	10.0% 29/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	5.0% 1/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Musculoskeletal and connective tissue disorders Myalgia	12.0% 35/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	15.0% 3/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Musculoskeletal and connective tissue disorders Pain in extremity	18.9% 55/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	10.0% 2/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Nervous system disorders Dizziness	17.5% 51/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	10.0% 2/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Nervous system disorders Headache	37.5% 109/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	45.0% 9/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Nervous system disorders Migraine	5.2% 15/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	5.0% 1/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Nervous system disorders Paraesthesia	9.6% 28/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Psychiatric disorders Anxiety	7.2% 21/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Psychiatric disorders Depression	6.5% 19/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Psychiatric disorders Insomnia	14.1% 41/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Renal and urinary disorders Dysuria	5.2% 15/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Respiratory, thoracic and mediastinal disorders Cough	24.1% 70/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	45.0% 9/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.6% 22/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	10.0% 2/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Respiratory, thoracic and mediastinal disorders Epistaxis	25.1% 73/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	25.0% 5/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Respiratory, thoracic and mediastinal disorders Nasal congestion	10.3% 30/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	30.0% 6/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Respiratory, thoracic and mediastinal disorders Oropharyngeal blistering	6.9% 20/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	17.2% 50/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	30.0% 6/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	8.9% 26/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	25.0% 5/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Skin and subcutaneous tissue disorders Blood blister	6.5% 19/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Skin and subcutaneous tissue disorders Ecchymosis	8.6% 25/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	5.0% 1/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Skin and subcutaneous tissue disorders Petechiae	18.2% 53/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	45.0% 9/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Skin and subcutaneous tissue disorders Pruritus	7.9% 23/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Skin and subcutaneous tissue disorders Rash	15.1% 44/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	25.0% 5/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Skin and subcutaneous tissue disorders Scab	0.00% 0/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	10.0% 2/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Skin and subcutaneous tissue disorders Skin lesion	6.2% 18/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	5.0% 1/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Vascular disorders Haematoma	12.7% 37/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	5.0% 1/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
Vascular disorders Hypertension	5.8% 17/291 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.	0.00% 0/20 • For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER