Trial Outcomes & Findings for Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA) (NCT NCT00537914)
NCT ID: NCT00537914
Last Updated: 2024-03-12
Results Overview
The development of diabetes in short children born SGA during treatment was evaluated based on the carbohydrate metabolism parameters FPG, HbA1c and OGTT (basal and 2-h plasma glucose). Only cases which were confirmed by the investigator were included.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
278 participants
Primary outcome timeframe
throughout the study, approximately 13 years
Results posted on
2024-03-12
Participant Flow
Study was carried out in 31 centers in 7 countries (Poland, Romania, Hungary, Czech Republic, Germany, Belgium and Georgia).
This study was not randomized. All enrolled patients received Omnitrope
Participant milestones
| Measure |
Omnitrope
All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.
|
|---|---|
|
Overall Study
STARTED
|
278
|
|
Overall Study
Full Analysis Set (FAS)
|
278
|
|
Overall Study
Safety Analysis Set (SAS)
|
277
|
|
Overall Study
COMPLETED
|
166
|
|
Overall Study
NOT COMPLETED
|
112
|
Reasons for withdrawal
| Measure |
Omnitrope
All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Treatment failure
|
10
|
|
Overall Study
patients documented other as reason for study discontinuation
|
16
|
|
Overall Study
Lost to Follow-up
|
19
|
|
Overall Study
Withdrawal of informed consent
|
59
|
Baseline Characteristics
Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)
Baseline characteristics by cohort
| Measure |
Omnitrope
n=278 Participants
All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.
|
|---|---|
|
Age, Continuous
|
7.36 years
STANDARD_DEVIATION 2.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
130 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
148 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
276 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Oriental
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other: specified as Mixed ethnic origin (Arabic/ Caucasian)
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: throughout the study, approximately 13 yearsPopulation: Safety analysis set: SAF comprised all patients who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment
The development of diabetes in short children born SGA during treatment was evaluated based on the carbohydrate metabolism parameters FPG, HbA1c and OGTT (basal and 2-h plasma glucose). Only cases which were confirmed by the investigator were included.
Outcome measures
| Measure |
Omnitrope
n=277 Participants
All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.
|
|---|---|
|
Number of Participants With Development of Diabetes in Short Children Born SGA During Treatment
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 1 year, 2 years, 5 years and 9 yearsPopulation: Full analysis set: FAS followed the ITT principle and comprised all patients who received at least 1 dose of study medication. Not all patients may have outcome data for all visits.
Mean change in Height from baseline for all patients was reported.
Outcome measures
| Measure |
Omnitrope
n=278 Participants
All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.
|
|---|---|
|
Mean Change in Height (H) (cm) From Baseline
3 months
|
2.74 cm
Interval 2.62 to 2.86
|
|
Mean Change in Height (H) (cm) From Baseline
1 year
|
9.08 cm
Interval 8.89 to 9.27
|
|
Mean Change in Height (H) (cm) From Baseline
2 years
|
16.52 cm
Interval 16.22 to 16.82
|
|
Mean Change in Height (H) (cm) From Baseline
5 years
|
35.10 cm
Interval 34.48 to 35.72
|
|
Mean Change in Height (H) (cm) From Baseline
9 years
|
58.07 cm
Interval 56.83 to 59.3
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 0.5 year, 9 months, 1 year, 1.25 years, 1.5 years, 1.75 years, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11 years, 12 years, 12.5 yearsPopulation: Full analysis set: FAS followed the ITT principle and comprised all patients who received at least 1 dose of study medication. Not all patients may have outcome data for all visits.
SDS reflects the deviation of a measured value from the mean value of normally growing children of the same sex and chronological age, expressed in units of the standard deviation (SD) of normally growing children of the same sex and chronological age. SDS was calculated according to the formula SDS=(X1-X2)/SD, where X1 is the measured value, X2 the mean value for the relevant chronological age and sex, and SD the reference standard deviation for the relevant sex and age. Refer to SAP page 14 for the formula and to Appendix B (H SDS) and D (HV SDS) for the applied reference Table. In general, a negative SDS indicates that the value is below average or mean and a positive value means it is above the average or mean. The calculated mean change compared to baseline reflects the catch-up growth over time towards average normal growth starting from below average.
Outcome measures
| Measure |
Omnitrope
n=278 Participants
All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.
|
|---|---|
|
Mean Change in Height Standard Deviation Score Over Time From Baseline
3 months
|
0.30 SDS
Interval 0.28 to 0.33
|
|
Mean Change in Height Standard Deviation Score Over Time From Baseline
0.5 year
|
0.51 SDS
Interval 0.47 to 0.54
|
|
Mean Change in Height Standard Deviation Score Over Time From Baseline
9 months
|
0.68 SDS
Interval 0.64 to 0.72
|
|
Mean Change in Height Standard Deviation Score Over Time From Baseline
1 year
|
0.81 SDS
Interval 0.76 to 0.86
|
|
Mean Change in Height Standard Deviation Score Over Time From Baseline
1.25 years
|
0.93 SDS
Interval 0.87 to 0.98
|
|
Mean Change in Height Standard Deviation Score Over Time From Baseline
1.5 years
|
1.04 SDS
Interval 0.98 to 1.1
|
|
Mean Change in Height Standard Deviation Score Over Time From Baseline
1.75 years
|
1.16 SDS
Interval 1.09 to 1.22
|
|
Mean Change in Height Standard Deviation Score Over Time From Baseline
2 years
|
1.25 SDS
Interval 1.18 to 1.31
|
|
Mean Change in Height Standard Deviation Score Over Time From Baseline
3 years
|
1.50 SDS
Interval 1.42 to 1.58
|
|
Mean Change in Height Standard Deviation Score Over Time From Baseline
4 years
|
1.67 SDS
Interval 1.57 to 1.77
|
|
Mean Change in Height Standard Deviation Score Over Time From Baseline
5 years
|
1.82 SDS
Interval 1.7 to 1.94
|
|
Mean Change in Height Standard Deviation Score Over Time From Baseline
6 years
|
1.94 SDS
Interval 1.81 to 2.07
|
|
Mean Change in Height Standard Deviation Score Over Time From Baseline
7 years
|
2.07 SDS
Interval 1.92 to 2.22
|
|
Mean Change in Height Standard Deviation Score Over Time From Baseline
8 years
|
2.19 SDS
Interval 2.03 to 2.35
|
|
Mean Change in Height Standard Deviation Score Over Time From Baseline
9 years
|
2.18 SDS
Interval 1.99 to 2.37
|
|
Mean Change in Height Standard Deviation Score Over Time From Baseline
10 years
|
2.21 SDS
Interval 2.0 to 2.43
|
|
Mean Change in Height Standard Deviation Score Over Time From Baseline
11 years
|
2.38 SDS
Interval 2.13 to 2.63
|
|
Mean Change in Height Standard Deviation Score Over Time From Baseline
12 years
|
2.39 SDS
Interval 1.81 to 2.97
|
|
Mean Change in Height Standard Deviation Score Over Time From Baseline
12.5 years
|
3.01 SDS
Interval 1.78 to 4.24
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 1 year, 2 years, 5 years and 9 yearsPopulation: Full analysis set: FAS followed the ITT principle and comprised all patients who received at least 1 dose of study medication. Not all patients may have outcome data for all visits.
Mean change in Height velocity (HV) (cm/year) over time from baseline was reported.
Outcome measures
| Measure |
Omnitrope
n=278 Participants
All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.
|
|---|---|
|
Mean Change in Height Velocity (HV) (cm/Year) Over Time From Baseline
3 months
|
6.45 cm/year
Interval 5.95 to 6.95
|
|
Mean Change in Height Velocity (HV) (cm/Year) Over Time From Baseline
1 year
|
4.71 cm/year
Interval 4.47 to 4.96
|
|
Mean Change in Height Velocity (HV) (cm/Year) Over Time From Baseline
2 years
|
3.02 cm/year
Interval 2.8 to 3.25
|
|
Mean Change in Height Velocity (HV) (cm/Year) Over Time From Baseline
5 years
|
1.37 cm/year
Interval 1.01 to 1.73
|
|
Mean Change in Height Velocity (HV) (cm/Year) Over Time From Baseline
9 years
|
0.10 cm/year
Interval -0.53 to 0.74
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 0.5 year, 9 months, 1 year, 1.25 years, 1.5 years, 1.75 years, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11 years, 12 years, 12.5 yearsPopulation: Full analysis set: FAS followed the ITT principle and comprised all patients who received at least 1 dose of study medication. Not all patients may have outcome data for all visits.
SDS reflects the deviation of a measured value from the mean value of normally growing children of the same sex and chronological age, expressed in units of the standard deviation (SD) of normally growing children of the same sex and chronological age. SDS was calculated according to the formula SDS=(X1-X2)/SD, where X1 is the measured value, X2 the mean value for the relevant chronological age and sex, and SD the reference standard deviation for the relevant sex and age. Refer to SAP page 14 for the formula and to Appendix B (H SDS) and D (HV SDS) for the applied reference Table. In general, a negative SDS indicates that the value is below average or mean and a positive value means it is above the average or mean. The calculated mean change compared to baseline reflects the initial high increase in height velocity which remains positive over years, but is decreasing over time.
Outcome measures
| Measure |
Omnitrope
n=278 Participants
All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.
|
|---|---|
|
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
3 months
|
8.41 SDS
Interval 7.76 to 9.07
|
|
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
0.5 year
|
7.27 SDS
Interval 6.83 to 7.71
|
|
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
9 months
|
6.69 SDS
Interval 6.31 to 7.06
|
|
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
1 year
|
6.26 SDS
Interval 5.92 to 6.59
|
|
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
1.25 years
|
5.29 SDS
Interval 4.99 to 5.6
|
|
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
1.5 years
|
4.85 SDS
Interval 4.55 to 5.15
|
|
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
1.75 years
|
4.59 SDS
Interval 4.28 to 4.91
|
|
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
2 years
|
4.35 SDS
Interval 4.02 to 4.68
|
|
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
3 years
|
3.62 SDS
Interval 3.23 to 4.0
|
|
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
4 years
|
3.08 SDS
Interval 2.68 to 3.47
|
|
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
5 years
|
2.99 SDS
Interval 2.5 to 3.49
|
|
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
6 years
|
2.63 SDS
Interval 2.14 to 3.13
|
|
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
7 years
|
2.43 SDS
Interval 1.95 to 2.92
|
|
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
8 years
|
1.37 SDS
Interval 0.75 to 1.98
|
|
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
9 years
|
0.85 SDS
Interval 0.14 to 1.55
|
|
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
10 years
|
0.62 SDS
Interval -0.24 to 1.47
|
|
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
11 years
|
1.60 SDS
Interval 0.36 to 2.84
|
|
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
12 years
|
1.34 SDS
Interval -0.5 to 3.18
|
|
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
12.5 years
|
1.98 SDS
Interval 1.74 to 2.22
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 1 year, 2 years, 5 years and 9 yearsPopulation: Full analysis set: FAS followed the ITT principle and comprised all patients who received at least 1 dose of study medication. Not all patients may have outcome data for all visits.
Mean change in serum IGF-1 level (nmol/L) from baseline was reported.
Outcome measures
| Measure |
Omnitrope
n=278 Participants
All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.
|
|---|---|
|
Mean Change in Serum IGF-1 Level (Nmol/L) From Baseline
3 months
|
13.04 nmol/L
Interval 11.56 to 14.52
|
|
Mean Change in Serum IGF-1 Level (Nmol/L) From Baseline
1 year
|
20.58 nmol/L
Interval 18.77 to 22.39
|
|
Mean Change in Serum IGF-1 Level (Nmol/L) From Baseline
2 years
|
30.64 nmol/L
Interval 28.16 to 33.12
|
|
Mean Change in Serum IGF-1 Level (Nmol/L) From Baseline
5 years
|
44.87 nmol/L
Interval 41.33 to 48.4
|
|
Mean Change in Serum IGF-1 Level (Nmol/L) From Baseline
9 years
|
75.72 nmol/L
Interval 69.59 to 81.85
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 1 year, 2 years, 5 years and 9 yearsPopulation: Full analysis set: FAS followed the ITT principle and comprised all patients who received at least 1 dose of study medication. Not all patients may have outcome data for all visits.
Mean change in IGFBP-3 levels (nmol/L) from baseline was reported.
Outcome measures
| Measure |
Omnitrope
n=278 Participants
All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.
|
|---|---|
|
Mean Change in IGFBP-3 Levels (Nmol/L) From Baseline
3 months
|
24.85 nmol/L
Interval 21.64 to 28.05
|
|
Mean Change in IGFBP-3 Levels (Nmol/L) From Baseline
1 year
|
30.48 nmol/L
Interval 27.04 to 33.92
|
|
Mean Change in IGFBP-3 Levels (Nmol/L) From Baseline
2 years
|
48.48 nmol/L
Interval 44.51 to 52.45
|
|
Mean Change in IGFBP-3 Levels (Nmol/L) From Baseline
5 years
|
92.94 nmol/L
Interval 87.65 to 98.23
|
|
Mean Change in IGFBP-3 Levels (Nmol/L) From Baseline
9 years
|
139.12 nmol/L
Interval 126.12 to 152.12
|
SECONDARY outcome
Timeframe: throughout the study, approximately 13 yearsPopulation: Safety analysis set: SAF comprised all patients who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment
Number of participants with the development of anti-rhGH antibodies with positive test result were reported.
Outcome measures
| Measure |
Omnitrope
n=277 Participants
All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.
|
|---|---|
|
Number of Participants With the Development of Anti-rhGH Antibodies During Omnitrope Treatment
|
23 Participants
|
Adverse Events
Omnitrope
Serious events: 74 serious events
Other events: 210 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Omnitrope
n=277 participants at risk
All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Congenital, familial and genetic disorders
Congenital arterial malformation
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Congenital, familial and genetic disorders
Developmental hip dysplasia
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
0.72%
2/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Endocrine disorders
Precocious puberty
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
3/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Gastrointestinal disorders
Dysphagia
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Gastrointestinal disorders
Eosinophilic oesophagitis
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Gastrointestinal disorders
Gastritis
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.1%
3/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Gastrointestinal disorders
Malabsorption
|
0.72%
2/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.72%
2/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
General disorders
Asthenia
|
0.72%
2/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
General disorders
Face oedema
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
General disorders
Obstruction
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
General disorders
Pyrexia
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Appendicitis
|
1.4%
4/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Bacterial sepsis
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Bronchitis
|
0.72%
2/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Ear infection
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Epididymitis
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Gastroenteritis
|
1.1%
3/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Giardiasis
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Helicobacter infection
|
0.72%
2/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Infectious mononucleosis
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Laryngitis
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Orchitis
|
0.72%
2/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Otitis media
|
1.4%
4/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Otitis media acute
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Otitis media chronic
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Peritonitis
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Pharyngitis
|
0.72%
2/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Pneumonia
|
1.1%
3/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Respiratory tract infection
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Rhinitis
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Subcutaneous abscess
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Urinary tract infection
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Injury, poisoning and procedural complications
Head injury
|
1.1%
3/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Injury, poisoning and procedural complications
Internal injury
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.1%
3/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.72%
2/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Injury, poisoning and procedural complications
Traumatic shock
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.72%
2/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Investigations
Cardiac murmur
|
0.72%
2/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Investigations
Intraocular pressure increased
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.72%
2/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pachydermodactyly
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Nervous system disorders
Brain oedema
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Nervous system disorders
Coma
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Nervous system disorders
Headache
|
1.1%
3/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Nervous system disorders
Intellectual disability
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Nervous system disorders
Seizure
|
1.1%
3/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Nervous system disorders
Syncope
|
1.1%
3/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Psychiatric disorders
Behaviour disorder
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Psychiatric disorders
Enuresis
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Renal and urinary disorders
Haematuria
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Renal and urinary disorders
Urethral fistula
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Renal and urinary disorders
Urinary retention
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.72%
2/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Reproductive system and breast disorders
Varicocele
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
2.5%
7/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.72%
2/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum perforation
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Vascular disorders
Circulatory collapse
|
0.36%
1/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
Other adverse events
| Measure |
Omnitrope
n=277 participants at risk
All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.
|
|---|---|
|
Endocrine disorders
Hypothyroidism
|
9.7%
27/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.6%
10/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.6%
10/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.6%
21/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
13/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
General disorders
Pyrexia
|
8.3%
23/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Immune system disorders
Hypersensitivity
|
4.0%
11/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Immune system disorders
Seasonal allergy
|
3.2%
9/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Bronchitis
|
20.9%
58/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Ear infection
|
5.1%
14/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Gastroenteritis
|
4.0%
11/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Influenza
|
4.0%
11/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Laryngitis
|
3.2%
9/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Nasopharyngitis
|
28.2%
78/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Otitis media
|
6.9%
19/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Otitis media acute
|
3.2%
9/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Pharyngitis
|
33.2%
92/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Pneumonia
|
6.1%
17/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Respiratory tract infection
|
9.0%
25/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Rhinitis
|
7.2%
20/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Scarlet fever
|
4.0%
11/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Sinusitis
|
5.4%
15/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Tonsillitis
|
12.6%
35/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.0%
47/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Urinary tract infection
|
6.1%
17/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Varicella
|
13.4%
37/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Infections and infestations
Viral infection
|
6.5%
18/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Investigations
Insulin-like growth factor increased
|
3.2%
9/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
4.3%
12/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Nervous system disorders
Headache
|
9.7%
27/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.2%
20/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.1%
14/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.3%
12/277 • Adverse events were collected from first dose of study treatment to end of the study i.e. up to 13 years.
Any signs or symptoms were collected from first dose of study treatment to end of the study i.e. up to 13 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER