Trial Outcomes & Findings for Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy (NCT NCT00174187)

Last Updated: 2012-12-04

Results Overview

Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

30 participants

Primary outcome timeframe

Baseline, Year 3

Results posted on

2012-12-04

Participant Flow

Participant milestones

Participant milestones
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- After Year 3 Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
Period 1 (up to 3 Years) STARTED	15	15	0
Period 1 (up to 3 Years) COMPLETED	15	11	0
Period 1 (up to 3 Years) NOT COMPLETED	0	4	0
Between Period 1 and Period 2 STARTED	0	0	26
Between Period 1 and Period 2 Consented	0	0	24
Between Period 1 and Period 2 COMPLETED	0	0	21
Between Period 1 and Period 2 NOT COMPLETED	0	0	5
Period 2 (After 3 Years) STARTED	0	0	21
Period 2 (After 3 Years) COMPLETED	0	0	13
Period 2 (After 3 Years) NOT COMPLETED	0	0	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Somatropin- Up To Year 3 (Nephrotic Syndrome) Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- After Year 3 Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
Period 1 (up to 3 Years) Serious adverse event	1	0
Period 1 (up to 3 Years) Non compliance	1	0
Period 1 (up to 3 Years) Withdrawal by Subject	1	0
Period 1 (up to 3 Years) Other	1	0
Between Period 1 and Period 2 Did not consent to continue treatment	0	2
Between Period 1 and Period 2 Consented, not assigned to treatment	0	3
Period 2 (After 3 Years) Lost to Follow-up	0	2
Period 2 (After 3 Years) Withdrawal by Subject	0	1
Period 2 (After 3 Years) Other	0	5

Baseline Characteristics

Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Total n=30 Participants Total of all reporting groups
Age Continuous	11.14 years STANDARD_DEVIATION 3.32 • n=5 Participants	11.96 years STANDARD_DEVIATION 3.80 • n=7 Participants	11.55 years STANDARD_DEVIATION 3.53 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Year 3

Population: Full Analysis Set (FAS) up to Year 3: included all participants who had at least 1 post-baseline height measurement and were treated with the study drug for at least 1 year.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3 Baseline	-3.6 Standard Deviation Score (SDS) Interval -5.1 to -2.3	-2.5 Standard Deviation Score (SDS) Interval -2.8 to -2.2
Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3 Change at Year 3	0.2 Standard Deviation Score (SDS) Interval -1.5 to 1.8	1.1 Standard Deviation Score (SDS) Interval 0.8 to 1.5

PRIMARY outcome

Timeframe: Baseline, when final height was reached (assessed up to Year 11)

Population: FAS- after Year 3: included all participants who received at least 1 dose of the study treatment and who had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=21 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height Change at Final Height (n = 4)	0.71 SDS Interval 0.27 to 3.08	—
Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height Baseline (n = 21)	-2.86 SDS Interval -5.61 to -1.0	—

PRIMARY outcome

Timeframe: Baseline, when final height was reached (assessed up to Year 11)

Population: FAS- after Year 3: included all participants who received at least one dose of the study treatment and who had at least one post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time point.

Body weight was measured using a balance scale. Weight SDS was obtained by measuring the weight, subtracting age- and gender-appropriate mean weight and dividing the result by standard deviation of that mean (as obtained from age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=21 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height Baseline (n = 21)	-1.53 SDS Interval -4.77 to 2.64	—
Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height Change at Final Height (n = 4)	-0.43 SDS Interval -1.37 to 1.09	—

PRIMARY outcome

Timeframe: When final height was reached (assessed up to Year 11)

Population: FAS- after Year 3: included all participants who received at least one dose of study treatment and who had at least one post-baseline height measurement. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants who were evaluable for given components of puberty assessment.

Pubertal stage (graded from I to V for breast development and pubic hair development) according to the Tanner's method was collected. A low stage (Stage I) corresponds to a pre-pubertal stage and a high stage (Stage V) to an adult stage.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=4 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Puberty Stage at Final Height Breast development: Stage I (n=1)	0 participants	—
Puberty Stage at Final Height Breast development: Stage II (n=1)	0 participants	—
Puberty Stage at Final Height Breast development: Stage III (n=1)	0 participants	—
Puberty Stage at Final Height Breast development: Stage IV (n=1)	0 participants	—
Puberty Stage at Final Height Breast development: Stage V (n=1)	1 participants	—
Puberty Stage at Final Height Pubic hair: Stage I (n=4)	0 participants	—
Puberty Stage at Final Height Pubic hair: Stage II (n=4)	0 participants	—
Puberty Stage at Final Height Pubic hair: Stage III (n=4)	0 participants	—
Puberty Stage at Final Height Pubic hair: Stage IV (n=4)	0 participants	—
Puberty Stage at Final Height Pubic hair: Stage V (n=4)	4 participants	—

SECONDARY outcome

Timeframe: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

Bone age was determined by the Greulich and Pyle method using left wrist and hand X-ray.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Bone Age Baseline (n = 14, 15)	8.9 years Interval 7.0 to 10.0	10.5 years Interval 7.0 to 13.0
Bone Age Year 1 (n = 14, 15)	9.5 years Interval 7.8 to 11.5	11.5 years Interval 7.0 to 14.0
Bone Age Year 2 (n = 15, 13)	10.0 years Interval 8.0 to 13.0	14.0 years Interval 10.0 to 14.5
Bone Age Year 3 (n = 15, 14)	11.3 years Interval 8.8 to 14.5	14.0 years Interval 11.5 to 15.0

SECONDARY outcome

Timeframe: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Lean body mass, a measurement of body composition, was assessed by Dual Energy X-ray Absorptiometry (DEXA) scan.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Lean Body Mass Baseline (n = 15, 15)	17.69 kilogram (kg) Interval 14.96 to 19.96	23.56 kilogram (kg) Interval 16.77 to 32.43
Lean Body Mass Year 1 (n = 15, 13)	19.77 kilogram (kg) Interval 16.62 to 24.58	31.16 kilogram (kg) Interval 20.77 to 39.1
Lean Body Mass Year 2 (n = 14, 12)	21.20 kilogram (kg) Interval 18.79 to 25.13	34.14 kilogram (kg) Interval 25.3 to 46.3
Lean Body Mass Year 3 (n = 14, 11)	23.21 kilogram (kg) Interval 20.88 to 25.55	36.38 kilogram (kg) Interval 26.49 to 42.76

SECONDARY outcome

Timeframe: Baseline, Year 1, 2, 3

Lean body mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Lean body mass at current year minus lean body mass at previous year) divided by lean body mass at previous year, multiplied by 100.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Annual Percent Change in Lean Body Mass at Year 1, 2 and 3 Annual Change at Year 1 (n = 15, 13)	18.95 percent change Interval 10.04 to 21.83	22.97 percent change Interval 17.54 to 28.8
Annual Percent Change in Lean Body Mass at Year 1, 2 and 3 Annual Change at Year 2 (n = 14, 11)	7.75 percent change Interval 1.31 to 12.16	7.33 percent change Interval 4.76 to 18.91
Annual Percent Change in Lean Body Mass at Year 1, 2 and 3 Annual Change at Year 3 (n = 13, 9)	9.83 percent change Interval 2.67 to 13.33	7.90 percent change Interval 1.88 to 15.08

SECONDARY outcome

Timeframe: Baseline, Year 3

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Lean body mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Lean body mass at Year 3 minus lean body mass at baseline) divided by lean body mass at baseline, multiplied by 100.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=14 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=11 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Percent Change From Baseline in Lean Body Mass at Year 3	36.82 percent change Interval 22.45 to 52.39	54.44 percent change Interval 43.06 to 62.3

SECONDARY outcome

Timeframe: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Lean body mass, a measurement of body composition, was assessed by DEXA scan.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Lean Body Mass as Percentage of Total Weight Year 2 (n = 14, 12)	73.32 percentage of total weight Interval 63.85 to 80.96	69.95 percentage of total weight Interval 59.55 to 80.07
Lean Body Mass as Percentage of Total Weight Year 3 (n = 14, 11)	72.94 percentage of total weight Interval 66.79 to 78.21	67.24 percentage of total weight Interval 59.83 to 74.37
Lean Body Mass as Percentage of Total Weight Baseline (n = 15, 15)	70.56 percentage of total weight Interval 58.25 to 80.1	60.69 percentage of total weight Interval 55.29 to 69.14
Lean Body Mass as Percentage of Total Weight Year 1 (n = 15, 13)	76.57 percentage of total weight Interval 64.16 to 83.89	65.97 percentage of total weight Interval 59.58 to 76.19

SECONDARY outcome

Timeframe: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Lean body mass was assessed by DEXA scan. Lean body mass SDS/CA was obtained by measuring lean body mass, subtracting the chronological age- and gender-appropriate mean lean body mass and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA) Year 2 (n = 14, 12)	-1.26 SDS Interval -1.94 to -0.78	-0.87 SDS Interval -1.4 to -0.32
Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA) Year 3 (n = 13, 11)	-1.75 SDS Interval -1.96 to -0.94	-1.29 SDS Interval -2.36 to -0.14
Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA) Baseline (n = 15, 15)	-1.50 SDS Interval -1.81 to -0.94	-0.90 SDS Interval -1.4 to -0.54
Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA) Year 1 (n = 15, 13)	-1.13 SDS Interval -1.64 to -0.67	-0.52 SDS Interval -0.97 to 0.2

SECONDARY outcome

Timeframe: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Fat mass, a measurement of body composition, was assessed by DEXA scan.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Fat Mass Baseline (n = 15, 15)	5.47 kg Interval 4.04 to 11.34	13.62 kg Interval 9.51 to 18.05
Fat Mass Year 1 (n = 15, 13)	4.81 kg Interval 2.64 to 10.21	10.99 kg Interval 7.22 to 18.97
Fat Mass Year 2 (n = 14, 12)	6.97 kg Interval 3.12 to 11.48	16.70 kg Interval 5.99 to 20.59
Fat Mass Year 3 (n = 14, 11)	6.90 kg Interval 4.94 to 11.33	15.19 kg Interval 10.28 to 22.87

SECONDARY outcome

Timeframe: Baseline, Year 1, 2, 3

Fat mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Fat mass at current year minus fat mass at previous year) divided by fat mass at previous year, multiplied by 100.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Annual Percent Change in Fat Mass at Year 1, 2 and 3 Annual Change at Year 1 (n = 15, 13)	-11.21 percent change Interval -24.18 to 27.46	-3.71 percent change Interval -19.44 to 15.73
Annual Percent Change in Fat Mass at Year 1, 2 and 3 Annual Change at Year 3 (n = 13, 9)	26.61 percent change Interval -4.54 to 52.9	19.37 percent change Interval 10.6 to 40.12
Annual Percent Change in Fat Mass at Year 1, 2 and 3 Annual Change at Year 2 (n = 14, 11)	29.52 percent change Interval 4.97 to 34.56	-1.05 percent change Interval -20.82 to 79.15

SECONDARY outcome

Timeframe: Baseline, Year 3

Fat mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Fat mass at Year 3 minus fat mass at baseline) divided by fat mass at baseline, multiplied by 100.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=14 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=11 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Percent Change From Baseline in Fat Mass at Year 3	19.46 percent change Interval 3.83 to 73.79	37.56 percent change Interval 8.18 to 44.15

SECONDARY outcome

Timeframe: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Fat mass, a measurement of body composition, was assessed by DEXA scan.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Fat Mass as Percentage of Total Weight Baseline (n = 15, 15)	25.0 percentage of total weight Interval 13.7 to 35.8	33.8 percentage of total weight Interval 29.5 to 37.2
Fat Mass as Percentage of Total Weight Year 1 (n = 15, 13)	17.4 percentage of total weight Interval 12.3 to 31.4	30.0 percentage of total weight Interval 21.9 to 34.7
Fat Mass as Percentage of Total Weight Year 2 (n = 14, 12)	21.1 percentage of total weight Interval 14.2 to 32.4	27.1 percentage of total weight Interval 15.0 to 36.2
Fat Mass as Percentage of Total Weight Year 3 (n = 14, 11)	21.3 percentage of total weight Interval 17.1 to 28.6	26.4 percentage of total weight Interval 19.1 to 37.6

SECONDARY outcome

Timeframe: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Fat mass was assessed by DEXA scan. Fat mass SDS/CA was obtained by measuring fat mass, subtracting chronological age- and gender-appropriate mean fat mass and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA) Baseline (n = 15, 15)	1.51 SDS Interval 0.5 to 2.22	2.20 SDS Interval 1.95 to 2.39
Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA) Year 1 (n = 15, 13)	0.80 SDS Interval -0.33 to 1.64	1.98 SDS Interval 0.88 to 2.23
Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA) Year 2 (n = 14, 12)	0.86 SDS Interval -0.15 to 1.66	1.79 SDS Interval 0.55 to 2.33
Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA) Year 3 (n = 13, 11)	1.27 SDS Interval 0.25 to 1.55	1.74 SDS Interval 0.9 to 2.41

SECONDARY outcome

Timeframe: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

BMAD (LS) was assessed by DEXA scan.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS]) Baseline (n = 15, 14)	0.184 gram per cubic centimeter (g/cm^3) Interval 0.168 to 0.242	0.223 gram per cubic centimeter (g/cm^3) Interval 0.211 to 0.241
Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS]) Year 1 (n = 14, 13)	0.209 gram per cubic centimeter (g/cm^3) Interval 0.163 to 0.243	0.237 gram per cubic centimeter (g/cm^3) Interval 0.201 to 0.244
Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS]) Year 2 (n = 15, 14)	0.215 gram per cubic centimeter (g/cm^3) Interval 0.181 to 0.248	0.249 gram per cubic centimeter (g/cm^3) Interval 0.217 to 0.266
Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS]) Year 3 (n = 13, 12)	0.239 gram per cubic centimeter (g/cm^3) Interval 0.205 to 0.254	0.242 gram per cubic centimeter (g/cm^3) Interval 0.223 to 0.266

SECONDARY outcome

Timeframe: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

BMAD (LS) was assessed by DEXA scan. BMAD (LS) (SDS/CA) was obtained by measuring the BMAD (LS), subtracting chronological age- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA]) Year 2 (n = 15, 14)	-2.55 SDS Interval -3.74 to -0.95	-1.42 SDS Interval -1.86 to -0.72
Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA]) Year 3 (n 12, 12)	-1.77 SDS Interval -2.43 to -1.21	-1.63 SDS Interval -2.43 to -0.74
Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA]) Baseline (n = 15, 14)	-3.21 SDS Interval -4.02 to -1.26	-1.53 SDS Interval -1.94 to -1.35
Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA]) Year 1 (n = 14, 13)	-2.66 SDS Interval -3.7 to -1.07	-1.51 SDS Interval -2.32 to -0.95

SECONDARY outcome

Timeframe: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

BMAD (LS) was assessed by DEXA scan. BMAD (LS) (SDS/Tanner Puberty Stage) was obtained by measuring BMAD (LS), subtracting Tanner puberty stage- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage]) Baseline (n = 8, 8)	-4.27 SDS Interval -5.47 to -2.38	-3.09 SDS Interval -3.36 to -2.31
Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage]) Year 1 (n = 10, 7)	-3.70 SDS Interval -4.8 to -2.48	-3.23 SDS Interval -4.64 to -1.74
Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage]) Year 2 (n = 10, 9)	-4.11 SDS Interval -4.36 to -1.72	-2.60 SDS Interval -3.04 to -2.17
Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage]) Year 3 (n = 10, 8)	-3.04 SDS Interval -4.06 to -2.27	-2.96 SDS Interval -3.37 to -2.76

SECONDARY outcome

Timeframe: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

BMD (TB) was assessed by DEXA scan.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Bone Mineral Density of Total Body (BMD [TB]) Baseline (n = 15, 15)	0.78 gram per square centimeter (g/cm^2) Interval 0.76 to 0.86	0.90 gram per square centimeter (g/cm^2) Interval 0.81 to 1.0
Bone Mineral Density of Total Body (BMD [TB]) Year 2 (n = 14, 11)	0.81 gram per square centimeter (g/cm^2) Interval 0.77 to 0.89	0.96 gram per square centimeter (g/cm^2) Interval 0.86 to 1.09
Bone Mineral Density of Total Body (BMD [TB]) Year 1 (n = 15, 14)	0.80 gram per square centimeter (g/cm^2) Interval 0.76 to 0.87	0.92 gram per square centimeter (g/cm^2) Interval 0.85 to 1.02
Bone Mineral Density of Total Body (BMD [TB]) Year 3 (n = 13, 11)	0.84 gram per square centimeter (g/cm^2) Interval 0.8 to 0.91	0.99 gram per square centimeter (g/cm^2) Interval 0.89 to 1.08

SECONDARY outcome

Timeframe: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

BMD (LS) was assessed by DEXA scan.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Bone Mineral Density of Lumbar Spine (BMD [LS]) Baseline (n = 15, 15)	0.55 g/cm^2 Interval 0.47 to 0.64	0.72 g/cm^2 Interval 0.67 to 0.85
Bone Mineral Density of Lumbar Spine (BMD [LS]) Year 1 (n = 14, 14)	0.61 g/cm^2 Interval 0.48 to 0.74	0.76 g/cm^2 Interval 0.66 to 0.91
Bone Mineral Density of Lumbar Spine (BMD [LS]) Year 2 (n = 15, 14)	0.64 g/cm^2 Interval 0.56 to 0.84	0.85 g/cm^2 Interval 0.77 to 1.04
Bone Mineral Density of Lumbar Spine (BMD [LS]) Year 3 (n = 13, 12)	0.74 g/cm^2 Interval 0.6 to 0.85	0.93 g/cm^2 Interval 0.79 to 1.07

SECONDARY outcome

Timeframe: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

DEXA scan of BMC was used to evaluate potential bone effects of treatment. BMC is an estimate of the amount of mineral (such as calcium) in the bone.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Bone Mineral Content of Total Body (BMC [TB]) Baseline (n = 15, 15)	636.36 gram Interval 498.47 to 939.71	1233.58 gram Interval 772.41 to 1650.08
Bone Mineral Content of Total Body (BMC [TB]) Year 1 (n = 15, 14)	775.46 gram Interval 578.97 to 1119.6	1576.15 gram Interval 939.71 to 1739.38
Bone Mineral Content of Total Body (BMC [TB]) Year 2 (n = 14, 11)	855.70 gram Interval 690.07 to 1059.67	2003.49 gram Interval 1070.42 to 2243.61
Bone Mineral Content of Total Body (BMC [TB]) Year 3 (n = 13, 11)	1112.78 gram Interval 807.3 to 1176.7	1997.74 gram Interval 1296.0 to 2195.17

SECONDARY outcome

Timeframe: Baseline, Year 1, 2, 3

BMC is an estimate of the amount of mineral (such as calcium) in the bone. Annual percent change: (BMC \[TB\] at current year minus BMC \[TB\] at previous year) divided by BMC \[TB\] at previous year, multiplied by 100.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3 Year 1 (n = 15, 14)	12.51 percent change Interval 7.66 to 21.86	20.16 percent change Interval 11.74 to 23.05
Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3 Year 2 (n = 14, 11)	17.47 percent change Interval 12.2 to 19.93	13.91 percent change Interval 10.63 to 18.93
Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3 Year 3 (n = 12, 9)	12.03 percent change Interval 4.5 to 14.54	7.39 percent change Interval 7.29 to 13.3

SECONDARY outcome

Timeframe: Baseline, Year 3

BMC is an estimate of the amount of mineral (such as calcium) in the bone. Percent change: (BMC \[TB\] at Year 3 minus BMC \[TB\] at baseline) divided by BMC \[TB\] at baseline, multiplied by 100.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=13 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=11 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Percent Change From Baseline in Bone Mineral Content of Total Body (BMC [TB]) at Year 3	46.63 percent change Interval 24.94 to 73.91	60.56 percent change Interval 36.49 to 67.79

SECONDARY outcome

Timeframe: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

BMC (TB) was measured by DEXA scan. BMC (TB) (SDS/CA) was obtained by measuring BMC (TB), subtracting the chronological age- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA]) Baseline (n = 15, 15)	-1.95 SDS Interval -2.6 to -1.03	-0.42 SDS Interval -1.23 to 0.19
Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA]) Year 1 (n = 15, 14)	-1.85 SDS Interval -2.43 to -0.73	-0.19 SDS Interval -1.13 to 0.37
Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA]) Year 2 (n = 14, 11)	-1.66 SDS Interval -2.27 to -1.14	-0.37 SDS Interval -1.24 to 0.43
Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA]) Year 3 (n = 12, 11)	-1.65 SDS Interval -2.22 to -0.35	-0.09 SDS Interval -0.72 to 0.6

SECONDARY outcome

Timeframe: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

BMC (TB) was measured by DEXA scan. BMC (TB) (SDS/Tanner Puberty Stage) was obtained by measuring BMC (TB), subtracting the Tanner puberty stage- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage]) Baseline (n = 8, 8)	-2.19 SDS Interval -2.47 to -0.96	1.41 SDS Interval -0.39 to 2.46
Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage]) Year 2 (n = 9, 7)	-2.38 SDS Interval -2.72 to -1.14	-0.47 SDS Interval -1.53 to 0.37
Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage]) Year 3 (n = 9, 7)	-2.38 SDS Interval -2.56 to -1.28	-0.17 SDS Interval -1.22 to 0.83
Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage]) Year 1 (n = 10, 8)	-1.56 SDS Interval -2.24 to -0.92	-0.52 SDS Interval -1.53 to 1.65

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Growth velocity measures the annual rate of increase in height.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Growth Velocity (GV) Baseline (n = 11, 14)	2.9 cm/year Interval 1.1 to 4.8	3.8 cm/year Interval 2.7 to 4.4
Growth Velocity (GV) Year 1 (n = 14, 15)	6.5 cm/year Interval 3.5 to 8.6	8.3 cm/year Interval 5.4 to 8.7
Growth Velocity (GV) Year 2 (n = 14, 15)	5.3 cm/year Interval 1.8 to 6.9	7.0 cm/year Interval 4.1 to 9.2
Growth Velocity (GV) Year 3 (n = 14, 14)	4.5 cm/year Interval 1.9 to 6.8	5.9 cm/year Interval 2.3 to 7.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

GV measures the annual rate of increase in height. GV (SDS/CA) was obtained by measuring GV, subtracting the chronological age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA]) Baseline (n = 10, 14)	-1.7 SDS Interval -2.8 to -1.3	-2.2 SDS Interval -2.9 to -1.3
Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA]) Year 1 (n = 14, 15)	1.0 SDS Interval -1.5 to 3.9	1.3 SDS Interval -0.7 to 1.9
Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA]) Year 2 (n = 14, 15)	0.1 SDS Interval -1.9 to 3.7	2.9 SDS Interval 1.4 to 4.2
Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA]) Year 3 (n = 14, 14)	0.4 SDS Interval -0.5 to 2.1	2.9 SDS Interval -0.1 to 5.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

GV measures the annual rate of increase in height. GV (SDS/BA) was obtained by measuring GV, subtracting the bone age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from bone age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA]) Year 3 (n = 14, 14)	-0.9 SDS Interval -2.2 to 0.9	0.1 SDS Interval -1.7 to 3.4
Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA]) Baseline (n = 9, 14)	-2.8 SDS Interval -3.9 to -1.7	-2.1 SDS Interval -2.4 to -1.1
Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA]) Year 1 (n = 13, 15)	0.8 SDS Interval -0.9 to 2.9	0.6 SDS Interval -0.6 to 2.4
Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA]) Year 2 (n = 14, 13)	-0.3 SDS Interval -3.9 to 1.1	1.4 SDS Interval -0.6 to 2.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Year 1, 2, 3

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 Participants Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3 Baseline (n = 15, 12)	157.0 nanogram per milliliter (ng/mL) Interval 61.0 to 345.0	344.5 nanogram per milliliter (ng/mL) Interval 191.0 to 719.0
Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3 Year 1 (n = 15, 15)	400.0 nanogram per milliliter (ng/mL) Interval 154.0 to 1370.0	952.0 nanogram per milliliter (ng/mL) Interval 424.0 to 1658.0
Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3 Year 2 (n = 15, 14)	388.0 nanogram per milliliter (ng/mL) Interval 188.0 to 1338.0	880.0 nanogram per milliliter (ng/mL) Interval 311.0 to 1718.0
Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3 Year 3 (n = 15, 14)	405.0 nanogram per milliliter (ng/mL) Interval 239.0 to 1160.0	657.0 nanogram per milliliter (ng/mL) Interval 323.0 to 1298.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Year 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10; 0.5 and 1 year after somatropin discontinuation, Final Height (assessed up to Year 11)

Population: FAS After year 3: included all participants who received at least 1 dose of the study treatment and who had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time point.

Outcome measures

Outcome measures
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=21 Participants Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3 Final height (n = 3)	0.06 milligram per deciliter (mg/dL) Interval 0.05 to 0.07	—
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3 Year 3.5 (n = 8)	0.05 milligram per deciliter (mg/dL) Interval 0.04 to 0.09	—
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3 Year 4 (n = 19)	0.06 milligram per deciliter (mg/dL) Interval 0.03 to 0.1	—
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3 Year 4.5 (n = 16)	0.06 milligram per deciliter (mg/dL) Interval 0.02 to 0.14	—
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3 Year 5 (n = 17)	0.05 milligram per deciliter (mg/dL) Interval 0.02 to 0.09	—
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3 Year 5.5 (n = 11)	0.06 milligram per deciliter (mg/dL) Interval 0.02 to 0.09	—
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3 Year 6 (n = 14)	0.05 milligram per deciliter (mg/dL) Interval 0.02 to 0.08	—
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3 Year 6.5 (n = 8)	0.07 milligram per deciliter (mg/dL) Interval 0.02 to 0.09	—
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3 Year 7 (n = 8)	0.06 milligram per deciliter (mg/dL) Interval 0.02 to 0.07	—
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3 Year 7.5 (n = 4)	0.05 milligram per deciliter (mg/dL) Interval 0.03 to 0.07	—
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3 Year 8 (n = 6)	0.06 milligram per deciliter (mg/dL) Interval 0.03 to 0.07	—
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3 Year 8.5 (n = 2)	0.08 milligram per deciliter (mg/dL) Interval 0.07 to 0.08	—
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3 Year 9 (n = 2)	0.06 milligram per deciliter (mg/dL) Interval 0.06 to 0.07	—
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3 Year 9.5 (n = 1)	0.07 milligram per deciliter (mg/dL) Interval 0.07 to 0.07	—
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3 Year 10 (n = 1)	0.05 milligram per deciliter (mg/dL) Interval 0.05 to 0.05	—
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3 0.5 years after somatropin discontinuation (n = 2)	0.03 milligram per deciliter (mg/dL) Interval 0.03 to 0.04	—
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3 1 year after somatropin discontinuation (n = 2)	0.03 milligram per deciliter (mg/dL) Interval 0.02 to 0.05	—

Adverse Events

Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)

Serious events: 13 serious events

Other events: 13 other events

Deaths: 0 deaths

Somatropin- Up To Year 3 (Nephrotic Syndrome)

Serious events: 14 serious events

Other events: 14 other events

Deaths: 0 deaths

Somatropin- After Year 3

Serious events: 19 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 participants at risk Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 participants at risk Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- After Year 3 n=21 participants at risk Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
Infections and infestations Viral infection	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	13.3% 2/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	19.0% 4/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthritis	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Biopsy kidney	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Cellulitis	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Condition aggravated	20.0% 3/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	13.3% 2/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depression	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Diabetes mellitus	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	13.3% 2/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Disease recurrence	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis	13.3% 2/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastric perforation	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes zoster	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes zoster ophthalmic	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Inflammation	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Inguinal hernia	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Insulin resistant diabetes	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Intussusception	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Juvenile arthritis	13.3% 2/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	28.6% 6/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	60.0% 9/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	19.0% 4/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Osteonecrosis	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	13.3% 2/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal colic	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure acute	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	20.0% 3/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Vertigo	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Visual acuity reduced	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Head injury	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Glaucoma	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Keratopathy	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Appendicitis	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tooth infection	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events
Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n=15 participants at risk Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- Up To Year 3 (Nephrotic Syndrome) n=15 participants at risk Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.	Somatropin- After Year 3 n=21 participants at risk Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
Gastrointestinal disorders Abdominal pain	13.3% 2/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 3/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	13.3% 2/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	13.3% 2/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Hypercoagulation	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Angina pectoris	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Auricular perichondritis	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Deafness	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Uveitis	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 3/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Face oedema	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Hyperthermia	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	13.3% 2/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Bronchitis	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Diarrhoea infectious	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Ear infection	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 3/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	13.3% 2/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 3/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Influenza	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 3/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pharyngitis	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Rhinitis	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 3/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tracheobronchitis	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Viral infection	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Viral tracheitis	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Joint sprain	13.3% 2/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Insulin-like growth factor increased	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 3/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 3/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Red blood cell sedimentation rate increased	33.3% 5/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	19.0% 4/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Anorexia	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Fluid retention	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	13.3% 2/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperinsulinaemia	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 3/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Malnutrition	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Sodium retention	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	19.0% 4/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Joint effusion	26.7% 4/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	19.0% 4/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Juvenile arthritis	20.0% 3/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	23.8% 5/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Osteopenia	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Synovitis	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.