Trial Outcomes & Findings for Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA) (NCT NCT01859949)
NCT ID: NCT01859949
Last Updated: 2016-05-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
62 participants
Primary outcome timeframe
Month 12 (at the end of previous study) to 156
Results posted on
2016-05-03
Participant Flow
Before enrolled this study, participants with short stature due to SGA had completed the 1-year(12-month) treatment in previous study. Out of 62 participants who were enrolled this study, 61 participants were treated.
Participant milestones
| Measure |
Dose-Increasing Group
Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
|
Dose-Remaining Group
Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
32
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
14
|
17
|
Reasons for withdrawal
| Measure |
Dose-Increasing Group
Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
|
Dose-Remaining Group
Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
|
|---|---|---|
|
Overall Study
Family Matters
|
0
|
1
|
|
Overall Study
Physician Decision
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
11
|
10
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)
Baseline characteristics by cohort
| Measure |
Dose-Increasing Group
n=29 Participants
Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
|
Dose-Remaining Group
n=32 Participants
Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.20 years
STANDARD_DEVIATION 1.64 • n=5 Participants
|
5.40 years
STANDARD_DEVIATION 1.27 • n=7 Participants
|
5.31 years
STANDARD_DEVIATION 1.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 12 (at the end of previous study) to 156Population: Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.
Outcome measures
| Measure |
Dose-Increasing Group
n=29 Participants
Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
|
Dose-Remaining Group
n=32 Participants
Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE
|
27 participant
|
31 participant
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAE
|
10 participant
|
5 participant
|
SECONDARY outcome
Timeframe: Month 12 (at the end of previous study) to 156Population: Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.
Height velocity is the yearly height gain. Height velocity SDS is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values of the participants age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
Outcome measures
| Measure |
Dose-Increasing Group
n=29 Participants
Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
|
Dose-Remaining Group
n=32 Participants
Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
|
|---|---|---|
|
Height Velocity Standard Deviation Score (SDS) for Chronological Age
Month 12 to 24 (Increasing: n=28, Remaining: n=32)
|
2.782 SDS
Standard Deviation 1.978
|
2.595 SDS
Standard Deviation 1.731
|
|
Height Velocity Standard Deviation Score (SDS) for Chronological Age
Month 24 to36 (Increasing:n=26, Remaining:n=28)
|
1.812 SDS
Standard Deviation 1.526
|
1.696 SDS
Standard Deviation 2.111
|
|
Height Velocity Standard Deviation Score (SDS) for Chronological Age
Month 36 to 48 (Increasing: n=24, Remaining: n=23)
|
1.480 SDS
Standard Deviation 1.543
|
0.824 SDS
Standard Deviation 1.527
|
|
Height Velocity Standard Deviation Score (SDS) for Chronological Age
Month 48 to 60 (Increasing: n=21, Remaining: n=20)
|
-0.041 SDS
Standard Deviation 2.081
|
0.480 SDS
Standard Deviation 1.651
|
|
Height Velocity Standard Deviation Score (SDS) for Chronological Age
Month 60 to 72 (Increasing: n=20, Remaining: n=16)
|
-0.293 SDS
Standard Deviation 1.585
|
-0.046 SDS
Standard Deviation 2.434
|
|
Height Velocity Standard Deviation Score (SDS) for Chronological Age
Month 72 to 84 (Increasing: n=15, Remaining: n=16)
|
-0.488 SDS
Standard Deviation 3.117
|
-1.511 SDS
Standard Deviation 2.692
|
|
Height Velocity Standard Deviation Score (SDS) for Chronological Age
Month 84 to 96 (Increasing: n=11, Remaining: n=14)
|
0.263 SDS
Standard Deviation 1.802
|
-0.114 SDS
Standard Deviation 1.964
|
|
Height Velocity Standard Deviation Score (SDS) for Chronological Age
Month 96 to 108 (Increasing: n=9, Remaining: n=8)
|
0.521 SDS
Standard Deviation 2.058
|
-0.466 SDS
Standard Deviation 2.055
|
|
Height Velocity Standard Deviation Score (SDS) for Chronological Age
Month 108 to 120 (Increasing: n=6, Remaining: n=6)
|
-0.668 SDS
Standard Deviation 2.126
|
-0.590 SDS
Standard Deviation 2.693
|
|
Height Velocity Standard Deviation Score (SDS) for Chronological Age
Month 120 to 132 (Increasing: n=5, Remaining: n=4)
|
-1.080 SDS
Standard Deviation 1.953
|
1.173 SDS
Standard Deviation 3.042
|
|
Height Velocity Standard Deviation Score (SDS) for Chronological Age
Month 132 to 144 (Increasing: n=4, Remaining: n=2)
|
2.655 SDS
Standard Deviation 4.329
|
0.730 SDS
Standard Deviation 2.022
|
|
Height Velocity Standard Deviation Score (SDS) for Chronological Age
Month 144 to 156 (Increasing: n=3, Remaining: n=0)
|
3.373 SDS
Standard Deviation 1.995
|
NA SDS
Standard Deviation NA
Zero participants analyzed at this time point.
|
SECONDARY outcome
Timeframe: Month 12 (at the end of previous study) to 156Population: Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.
Height velocity is the yearly height gain
Outcome measures
| Measure |
Dose-Increasing Group
n=29 Participants
Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
|
Dose-Remaining Group
n=32 Participants
Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
|
|---|---|---|
|
Height Velocity
Month 12 to 24 (Increasing: n=28, Remaining: n=32)
|
7.83 cm/year
Standard Deviation 1.33
|
7.70 cm/year
Standard Deviation 1.19
|
|
Height Velocity
Month 24 to 36 (Increasing: n=26, Remaining: n=28)
|
6.88 cm/year
Standard Deviation 0.94
|
6.75 cm/year
Standard Deviation 1.52
|
|
Height Velocity
Month 36 to 48 (Increasing: n=24, Remaining: n=23)
|
6.68 cm/year
Standard Deviation 0.98
|
6.08 cm/year
Standard Deviation 1.14
|
|
Height Velocity
Month 48 to 60 (Increasing: n=21, Remaining: n=20)
|
6.06 cm/year
Standard Deviation 1.49
|
6.30 cm/year
Standard Deviation 1.24
|
|
Height Velocity
Month 60 to 72 (Increasing: n=20, Remaining: n=16)
|
6.08 cm/year
Standard Deviation 1.45
|
6.49 cm/year
Standard Deviation 1.37
|
|
Height Velocity
Month 72 to 84 (Increasing: n=15, Remaining: n=16)
|
4.89 cm/year
Standard Deviation 2.18
|
4.88 cm/year
Standard Deviation 1.86
|
|
Height Velocity
Month 84 to 96 (Increasing: n=11, Remaining: n=14)
|
5.16 cm/year
Standard Deviation 1.20
|
4.82 cm/year
Standard Deviation 2.12
|
|
Height Velocity
Month 96 to 108 (Increasing: n=9, Remaining: n=8)
|
5.18 cm/year
Standard Deviation 2.16
|
5.55 cm/year
Standard Deviation 2.42
|
|
Height Velocity
Month 108 to 120 (Increasing: n=6, Remaining: n=6)
|
5.72 cm/year
Standard Deviation 2.24
|
5.03 cm/year
Standard Deviation 1.86
|
|
Height Velocity
Month 120 to 132 (Increasing: n=5, Remaining: n=4)
|
4.84 cm/year
Standard Deviation 1.30
|
4.30 cm/year
Standard Deviation 1.84
|
|
Height Velocity
Month 132 to 144 (Increasing: n=4, Remaining: n=2)
|
4.38 cm/year
Standard Deviation 1.10
|
2.60 cm/year
Standard Deviation 0.14
|
|
Height Velocity
Month 144 to 156(Increasing: n=3, Remaining: n=0)
|
3.10 cm/year
Standard Deviation 1.92
|
NA cm/year
Standard Deviation NA
Zero participants analyzed at this time point.
|
SECONDARY outcome
Timeframe: Month 12 (at the end of previous study) to 156Population: Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.
Height SDS is calculated as following formula; Height SDS = (height - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values on the participant age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
Outcome measures
| Measure |
Dose-Increasing Group
n=29 Participants
Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
|
Dose-Remaining Group
n=32 Participants
Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
|
|---|---|---|
|
Height SDS for Chronological Age
Month 144 (Increasing: n=4, Remaining: n=2)
|
-1.73 SDS
Standard Deviation 0.87
|
-0.70 SDS
Standard Deviation 0.42
|
|
Height SDS for Chronological Age
Month 156 (Increasing: n=3, Remaining: n=0)
|
-1.77 SDS
Standard Deviation 0.76
|
NA SDS
Standard Deviation NA
Zero participants analyzed at this time point.
|
|
Height SDS for Chronological Age
Month 12 (Increasing: n=29, Remaining: n=32)
|
-2.53 SDS
Standard Deviation 0.92
|
-2.17 SDS
Standard Deviation 0.96
|
|
Height SDS for Chronological Age
Month 24 (Increasing: n=28, Remaining: n=32)
|
-2.02 SDS
Standard Deviation 0.97
|
-1.70 SDS
Standard Deviation 1.03
|
|
Height SDS for Chronological Age
Month 36 (Increasing: n=26, Remaining: n=28)
|
-1.80 SDS
Standard Deviation 0.99
|
-1.53 SDS
Standard Deviation 1.10
|
|
Height SDS for Chronological Age
Month 48 (Increasing: n=24, Remaining: n=23)
|
-1.48 SDS
Standard Deviation 1.05
|
-1.49 SDS
Standard Deviation 1.15
|
|
Height SDS for Chronological Age
Month 60 (Increasing: n=21, Remaining: n=20)
|
-1.53 SDS
Standard Deviation 1.06
|
-1.44 SDS
Standard Deviation 1.10
|
|
Height SDS for Chronological Age
Month 72 (Increasing: n=20, Remaining: n=16)
|
-1.56 SDS
Standard Deviation 1.11
|
-1.43 SDS
Standard Deviation 1.06
|
|
Height SDS for Chronological Age
Month 84 (Increasing: n=15, Remaining: n=16)
|
-1.73 SDS
Standard Deviation 1.13
|
-1.58 SDS
Standard Deviation 1.17
|
|
Height SDS for Chronological Age
Month 96 (Increasing: n=11, Remaining: n=14)
|
-1.52 SDS
Standard Deviation 0.89
|
-1.87 SDS
Standard Deviation 1.36
|
|
Height SDS for Chronological Age
Month 108 (Increasing: n=9, Remaining: n=8)
|
-1.52 SDS
Standard Deviation 1.01
|
-1.63 SDS
Standard Deviation 1.48
|
|
Height SDS for Chronological Age
Month 120 (Increasing: n=6, Remaining: n=6)
|
-1.52 SDS
Standard Deviation 1.20
|
-1.25 SDS
Standard Deviation 0.59
|
|
Height SDS for Chronological Age
Month 132 (Increasing: n=5, Remaining: n=4)
|
-1.96 SDS
Standard Deviation 1.11
|
-0.98 SDS
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: Month 12 (at the end of previous study) to 156Population: Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.
To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children. Height velocity is the yearly height gain. Height velocity SDS for bone age is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
Outcome measures
| Measure |
Dose-Increasing Group
n=29 Participants
Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
|
Dose-Remaining Group
n=32 Participants
Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
|
|---|---|---|
|
Height Velocity SDS for Bone Age
Month 12 to 24 (Increasing: n=26, Remaining: n=31)
|
2.586 SDS
Standard Deviation 2.268
|
2.461 SDS
Standard Deviation 1.990
|
|
Height Velocity SDS for Bone Age
Month 24 to 36 (Increasing: n=24, Remaining: n=27)
|
1.503 SDS
Standard Deviation 1.830
|
1.091 SDS
Standard Deviation 1.852
|
|
Height Velocity SDS for Bone Age
Month 36 to 48 (Increasing: n=22, Remaining: n=22)
|
1.196 SDS
Standard Deviation 1.409
|
0.510 SDS
Standard Deviation 1.809
|
|
Height Velocity SDS for Bone Age
Month 48 to 60 (Increasing: n=20, Remaining: n=19)
|
-0.062 SDS
Standard Deviation 1.775
|
0.913 SDS
Standard Deviation 2.146
|
|
Height Velocity SDS for Bone Age
Month 60 to 72 (Increasing: n=16, Remaining: n=14)
|
0.281 SDS
Standard Deviation 2.814
|
0.949 SDS
Standard Deviation 2.729
|
|
Height Velocity SDS for Bone Age
Month 72 to 84 (Increasing: n=13, Remaining: n=13)
|
-1.249 SDS
Standard Deviation 2.558
|
0.932 SDS
Standard Deviation 2.545
|
|
Height Velocity SDS for Bone Age
Month 84 to 96 (Increasing: n=10, Remaining: n=13)
|
0.804 SDS
Standard Deviation 3.440
|
0.286 SDS
Standard Deviation 2.351
|
|
Height Velocity SDS for Bone Age
Month 96 to 108 (Increasing: n=8, Remaining: n=7)
|
-0.634 SDS
Standard Deviation 2.419
|
-0.223 SDS
Standard Deviation 1.352
|
|
Height Velocity SDS for Bone Age
Month 108 to 120 (Increasing: n=5, Remaining: n=5)
|
0.070 SDS
Standard Deviation 4.120
|
0.532 SDS
Standard Deviation 1.809
|
|
Height Velocity SDS for Bone Age
Month 120 to 132 (Increasing: n=4, Remaining: n=4)
|
1.553 SDS
Standard Deviation 3.019
|
2.718 SDS
Standard Deviation 0.864
|
|
Height Velocity SDS for Bone Age
Month 132 to 144 (Increasing: n=3, Remaining: n=2)
|
2.310 SDS
Standard Deviation 1.711
|
2.185 SDS
Standard Deviation 0.304
|
|
Height Velocity SDS for Bone Age
Month 144 to 156 (Increasing: n=2, Remaining: n=0)
|
2.710 SDS
Standard Deviation 2.942
|
NA SDS
Standard Deviation NA
Zero participants analyzed at this time point.
|
SECONDARY outcome
Timeframe: Month 12 (at the end of previous study) to 156Population: Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.
To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children. Height SDS for bone age is calculated as following formula; Height SDS = (height - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
Outcome measures
| Measure |
Dose-Increasing Group
n=29 Participants
Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
|
Dose-Remaining Group
n=32 Participants
Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
|
|---|---|---|
|
Height SDS for Bone Age
Month 12 (Increasing: n=27, Remaining: n=31)
|
-1.19 SDS
Standard Deviation 1.20
|
-0.68 SDS
Standard Deviation 1.54
|
|
Height SDS for Bone Age
Month 24 (Increasing: n=26, Remaining: n=31)
|
-1.15 SDS
Standard Deviation 1.15
|
-0.88 SDS
Standard Deviation 1.79
|
|
Height SDS for Bone Age
Month 36 (Increasing: n=24, Remaining: n=27)
|
-1.20 SDS
Standard Deviation 1.35
|
-1.17 SDS
Standard Deviation 1.62
|
|
Height SDS for Bone Age
Month 48 (Increasing: n=22, Remaining: n=22)
|
-0.74 SDS
Standard Deviation 1.32
|
-1.46 SDS
Standard Deviation 1.01
|
|
Height SDS for Bone Age
Month 60 (Increasing: n=20, Remaining: n=19)
|
-1.16 SDS
Standard Deviation 1.21
|
-1.80 SDS
Standard Deviation 0.97
|
|
Height SDS for Bone Age
Month 72 (Increasing: n=16, Remaining: n=14)
|
-1.78 SDS
Standard Deviation 1.02
|
-1.70 SDS
Standard Deviation 0.77
|
|
Height SDS for Bone Age
Month 84 (Increasing: n=13, Remaining: n=13)
|
-1.85 SDS
Standard Deviation 1.17
|
-2.15 SDS
Standard Deviation 0.92
|
|
Height SDS for Bone Age
Month 96 (Increasing: n=10, Remaining: n=13)
|
-1.77 SDS
Standard Deviation 1.12
|
-2.27 SDS
Standard Deviation 1.06
|
|
Height SDS for Bone Age
Month 108 (Increasing: n=8, Remaining: n=7)
|
-1.41 SDS
Standard Deviation 0.97
|
-1.94 SDS
Standard Deviation 1.37
|
|
Height SDS for Bone Age
Month 120 (Increasing: n=5, Remaining: n=5)
|
-1.58 SDS
Standard Deviation 1.50
|
-1.38 SDS
Standard Deviation 0.98
|
|
Height SDS for Bone Age
Month 132 (Increasing: n=4, Remaining: n=4)
|
-2.10 SDS
Standard Deviation 1.21
|
-0.98 SDS
Standard Deviation 0.74
|
|
Height SDS for Bone Age
Month 144 (Increasing: n=3, Remaining: n=2)
|
-1.40 SDS
Standard Deviation 0.17
|
-0.65 SDS
Standard Deviation 0.64
|
|
Height SDS for Bone Age
Month 156 (Increasing: n=2, Remaining: n=0)
|
-1.55 SDS
Standard Deviation 0.92
|
NA SDS
Standard Deviation NA
Zero participants analyzed at this time point.
|
Adverse Events
Dose-Increasing Group
Serious events: 10 serious events
Other events: 27 other events
Deaths: 0 deaths
Dose-Remainig Group
Serious events: 5 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose-Increasing Group
n=29 participants at risk
Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
|
Dose-Remainig Group
n=32 participants at risk
Participants in the 0.067 mg/kg/day group in previous study were maintained on the dose in this expention study
|
|---|---|---|
|
Infections and infestations
INFECTION VIRAL
|
0.00%
0/29
|
3.1%
1/32
|
|
Infections and infestations
OTITIS MEDIA
|
3.4%
1/29
|
3.1%
1/32
|
|
Eye disorders
RETINAL DETACHMENT
|
0.00%
0/29
|
3.1%
1/32
|
|
Ear and labyrinth disorders
DEAFNESS
|
3.4%
1/29
|
0.00%
0/32
|
|
Gastrointestinal disorders
GASTROENTERITIS
|
6.9%
2/29
|
0.00%
0/32
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
3.4%
1/29
|
0.00%
0/32
|
|
Endocrine disorders
ADENOID HYPERTROPHY
|
3.4%
1/29
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGITIS
|
3.4%
1/29
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
3.4%
1/29
|
0.00%
0/32
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESP TRACT INFECTION
|
3.4%
1/29
|
0.00%
0/32
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS
|
3.4%
1/29
|
0.00%
0/32
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
3.4%
1/29
|
0.00%
0/32
|
|
Reproductive system and breast disorders
HERNIA INGUINAL
|
3.4%
1/29
|
3.1%
1/32
|
|
Reproductive system and breast disorders
OVARIAN DISORDER
|
3.4%
1/29
|
0.00%
0/32
|
|
Congenital, familial and genetic disorders
HYPOSPADIAS
|
3.4%
1/29
|
0.00%
0/32
|
|
Congenital, familial and genetic disorders
CRYPTORCHISM
|
3.4%
1/29
|
0.00%
0/32
|
|
Infections and infestations
HEALING IMPAIRED
|
0.00%
0/29
|
3.1%
1/32
|
|
General disorders
INFLICTED INJURY
|
3.4%
1/29
|
0.00%
0/32
|
Other adverse events
| Measure |
Dose-Increasing Group
n=29 participants at risk
Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
|
Dose-Remainig Group
n=32 participants at risk
Participants in the 0.067 mg/kg/day group in previous study were maintained on the dose in this expention study
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
ACNE
|
6.9%
2/29
|
9.4%
3/32
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
10.3%
3/29
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
20.7%
6/29
|
15.6%
5/32
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/29
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
RASH
|
10.3%
3/29
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
6.9%
2/29
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
RASH PUSTULAR
|
13.8%
4/29
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
SKIN DISORDER
|
10.3%
3/29
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
6.9%
2/29
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.00%
0/29
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
OTITIS EXTERNA
|
10.3%
3/29
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
BULLOUS ERUPTION
|
6.9%
2/29
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
VERRUCA
|
3.4%
1/29
|
12.5%
4/32
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
13.8%
4/29
|
15.6%
5/32
|
|
Nervous system disorders
HEADACHE
|
13.8%
4/29
|
9.4%
3/32
|
|
Eye disorders
CONJUNCTIVITIS
|
27.6%
8/29
|
37.5%
12/32
|
|
Eye disorders
EYE ABNORMALITY
|
13.8%
4/29
|
15.6%
5/32
|
|
Eye disorders
MYOPIA
|
6.9%
2/29
|
0.00%
0/32
|
|
Gastrointestinal disorders
CONSTIPATION
|
10.3%
3/29
|
12.5%
4/32
|
|
Gastrointestinal disorders
DIARRHOEA
|
17.2%
5/29
|
6.2%
2/32
|
|
Gastrointestinal disorders
VOMITING
|
17.2%
5/29
|
9.4%
3/32
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/29
|
6.2%
2/32
|
|
Gastrointestinal disorders
GASTROENTERITIS
|
58.6%
17/29
|
31.2%
10/32
|
|
Gastrointestinal disorders
NAUSEA
|
3.4%
1/29
|
6.2%
2/32
|
|
Gastrointestinal disorders
STOMATITIS
|
6.9%
2/29
|
3.1%
1/32
|
|
Gastrointestinal disorders
TOOTH CARIES
|
13.8%
4/29
|
6.2%
2/32
|
|
Gastrointestinal disorders
TOOTH DISORDER
|
3.4%
1/29
|
9.4%
3/32
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.00%
0/29
|
6.2%
2/32
|
|
Hepatobiliary disorders
SGOT INCREASED
|
10.3%
3/29
|
3.1%
1/32
|
|
Hepatobiliary disorders
SGPT INCREASED
|
10.3%
3/29
|
3.1%
1/32
|
|
Metabolism and nutrition disorders
GLUCOSE TOLERANCE ABNORMAL
|
3.4%
1/29
|
9.4%
3/32
|
|
Endocrine disorders
SIALOADENITIS
|
10.3%
3/29
|
6.2%
2/32
|
|
Cardiac disorders
HYPOTENSION POSTURAL
|
6.9%
2/29
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
COUGHING
|
0.00%
0/29
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGITIS
|
24.1%
7/29
|
28.1%
9/32
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
3.4%
1/29
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS
|
27.6%
8/29
|
37.5%
12/32
|
|
Respiratory, thoracic and mediastinal disorders
SINUSITIS
|
17.2%
5/29
|
12.5%
4/32
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESP TRACT INFECTION
|
86.2%
25/29
|
87.5%
28/32
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS
|
31.0%
9/29
|
31.2%
10/32
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
20.7%
6/29
|
18.8%
6/32
|
|
Blood and lymphatic system disorders
EOSINOPHILIA
|
6.9%
2/29
|
9.4%
3/32
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
6.9%
2/29
|
12.5%
4/32
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
3.4%
1/29
|
9.4%
3/32
|
|
Blood and lymphatic system disorders
LYMPHOCYTES ATYPICA
|
6.9%
2/29
|
0.00%
0/32
|
|
General disorders
PURPURA
|
20.7%
6/29
|
15.6%
5/32
|
|
General disorders
HAEMATOMA
|
6.9%
2/29
|
0.00%
0/32
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
6.9%
2/29
|
0.00%
0/32
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/29
|
9.4%
3/32
|
|
Reproductive system and breast disorders
OVARIAN DISORDER
|
10.3%
3/29
|
0.00%
0/32
|
|
Congenital, familial and genetic disorders
SKELETAL MALFORMATION
|
0.00%
0/29
|
6.2%
2/32
|
|
Congenital, familial and genetic disorders
TOOTH MALFORMATION
|
6.9%
2/29
|
3.1%
1/32
|
|
General disorders
ALLERGIC REACTION
|
0.00%
0/29
|
9.4%
3/32
|
|
General disorders
FEVER
|
37.9%
11/29
|
3.1%
1/32
|
|
General disorders
PAIN
|
0.00%
0/29
|
6.2%
2/32
|
|
General disorders
INFLUENZA-LIKE SYMPTOMS
|
55.2%
16/29
|
46.9%
15/32
|
|
Injury, poisoning and procedural complications
INJECTION SITE BLEEDING
|
6.9%
2/29
|
0.00%
0/32
|
|
Infections and infestations
INFECTION BACTERIAL
|
13.8%
4/29
|
18.8%
6/32
|
|
Infections and infestations
INFECTION VIRAL
|
6.9%
2/29
|
0.00%
0/32
|
|
Infections and infestations
OTITIS MEDIA
|
44.8%
13/29
|
43.8%
14/32
|
|
Infections and infestations
HERPES ZOSTER
|
6.9%
2/29
|
3.1%
1/32
|
|
Infections and infestations
ABSCESS
|
0.00%
0/29
|
6.2%
2/32
|
|
General disorders
VARICELLA
|
10.3%
3/29
|
6.2%
2/32
|
|
General disorders
INFLICTED INJURY
|
6.9%
2/29
|
12.5%
4/32
|
|
General disorders
MOLLUSCUM CONTAGIOSUM
|
0.00%
0/29
|
6.2%
2/32
|
|
General disorders
SCOLIOSIS
|
3.4%
1/29
|
6.2%
2/32
|
|
General disorders
LACERATION
|
3.4%
1/29
|
9.4%
3/32
|
|
Injury, poisoning and procedural complications
STING
|
3.4%
1/29
|
12.5%
4/32
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Restriction Description: 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