Trial Outcomes & Findings for Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature (NCT NCT00355030)
NCT ID: NCT00355030
Last Updated: 2019-09-30
Results Overview
A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
91 participants
Primary outcome timeframe
Baseline through End of Study (up to 9 years)
Results posted on
2019-09-30
Participant Flow
Participant milestones
| Measure |
Somatropin and Leuprorelin: Experimental Arm 1
0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
|
Somatropin: Experimental Arm 2
0.05mg/kg/day subcutaneous somatropin only
|
|---|---|---|
|
Study Period 1 Treatment
STARTED
|
46
|
45
|
|
Study Period 1 Treatment
Received At Least One Dose of Study Drug
|
45
|
43
|
|
Study Period 1 Treatment
COMPLETED
|
1
|
1
|
|
Study Period 1 Treatment
NOT COMPLETED
|
45
|
44
|
|
Study Period 2 Long Term Follow-Up
STARTED
|
20
|
19
|
|
Study Period 2 Long Term Follow-Up
COMPLETED
|
19
|
17
|
|
Study Period 2 Long Term Follow-Up
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Somatropin and Leuprorelin: Experimental Arm 1
0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
|
Somatropin: Experimental Arm 2
0.05mg/kg/day subcutaneous somatropin only
|
|---|---|---|
|
Study Period 1 Treatment
Adverse Event
|
1
|
1
|
|
Study Period 1 Treatment
Lost to Follow-up
|
3
|
0
|
|
Study Period 1 Treatment
Withdrawal by Subject
|
4
|
1
|
|
Study Period 1 Treatment
Parent/Caregiver Decision
|
1
|
2
|
|
Study Period 1 Treatment
Physician Decision
|
0
|
1
|
|
Study Period 1 Treatment
Sponsor Decision
|
34
|
32
|
|
Study Period 1 Treatment
Protocol Entry Criterion Not Met
|
0
|
1
|
|
Study Period 1 Treatment
Other
|
2
|
6
|
|
Study Period 2 Long Term Follow-Up
Lost to Follow-up
|
0
|
1
|
|
Study Period 2 Long Term Follow-Up
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature
Baseline characteristics by cohort
| Measure |
Somatropin and Leuprorelin
n=45 Participants
0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
|
Somatropin
n=43 Participants
0.05mg/kg/day subcutaneous somatropin only
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.1 years
STANDARD_DEVIATION 1.41 • n=5 Participants
|
12.1 years
STANDARD_DEVIATION 1.33 • n=7 Participants
|
12.1 years
STANDARD_DEVIATION 1.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
France
|
39 participants
n=5 Participants
|
38 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Standing Height SDS
|
-2.5 Standard Deviation Score
STANDARD_DEVIATION 0.45 • n=5 Participants
|
-2.5 Standard Deviation Score
STANDARD_DEVIATION 0.46 • n=7 Participants
|
-2.5 Standard Deviation Score
STANDARD_DEVIATION .045 • n=5 Participants
|
|
Standing Height
|
131.6 centimeters
STANDARD_DEVIATION 6.72 • n=5 Participants
|
131.6 centimeters
STANDARD_DEVIATION 5.78 • n=7 Participants
|
131.6 centimeters
STANDARD_DEVIATION 6.24 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through End of Study (up to 9 years)Population: All participants who received at least one dose of study drug in Period 1 and all participants who entered Period 2 (safety population).
A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
Somatropin and Leuprorelin
n=46 Participants
0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
|
Somatropin
n=45 Participants
0.05mg/kg/day subcutaneous somatropin only
|
|---|---|---|
|
Number of Participants With One or More Drug-related Adverse Events
Study Period 1 (n=46, 45)
|
42 participants
|
38 participants
|
|
Number of Participants With One or More Drug-related Adverse Events
Study Period 2 (n=20, 19)
|
11 participants
|
9 participants
|
PRIMARY outcome
Timeframe: Baseline through End of Study (up to 9 years)Population: All participants who received at least one dose of study drug with at least one follow up visit.
The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Outcome measures
| Measure |
Somatropin and Leuprorelin
n=19 Participants
0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
|
Somatropin
n=16 Participants
0.05mg/kg/day subcutaneous somatropin only
|
|---|---|---|
|
Adult Height Standard Deviation Score (SDS)
|
-1.8 standard deviation score
Standard Deviation 0.53
|
-1.9 standard deviation score
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: Baseline through End of Study (up to 9 years)Population: All participants who received at least one dose of study drug with at least one follow up visit. The safety follow up participants did not reach final height at end of Period 1 unless final height is noted for participants that reached final height at the end of Period 1.
Height velocity is the difference between 2 height measurements, divided by years elapsed between measurements.
Outcome measures
| Measure |
Somatropin and Leuprorelin
n=45 Participants
0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
|
Somatropin
n=43 Participants
0.05mg/kg/day subcutaneous somatropin only
|
|---|---|---|
|
Height Velocity
Month 30 (n=25, 25)
|
6.2 centimeter per year
Standard Deviation 2.09
|
5.8 centimeter per year
Standard Deviation 2.93
|
|
Height Velocity
Safety follow up 36 months (final height) (n=3,7)
|
0.9 centimeter per year
Standard Deviation 0.78
|
0.3 centimeter per year
Standard Deviation 0.60
|
|
Height Velocity
Randomization (n=45, 43)
|
7.8 centimeter per year
Standard Deviation 6.92
|
7.4 centimeter per year
Standard Deviation 6.03
|
|
Height Velocity
Month 3 (n=45, 43)
|
9.9 centimeter per year
Standard Deviation 3.94
|
10.6 centimeter per year
Standard Deviation 3.53
|
|
Height Velocity
Month 6 (n=45, 42)
|
8.1 centimeter per year
Standard Deviation 2.31
|
9.7 centimeter per year
Standard Deviation 2.80
|
|
Height Velocity
Month 12 (n=44, 42)
|
7.0 centimeter per year
Standard Deviation 1.64
|
8.8 centimeter per year
Standard Deviation 2.33
|
|
Height Velocity
Month 18 (n=42, 42)
|
6.6 centimeter per year
Standard Deviation 1.68
|
8.4 centimeter per year
Standard Deviation 2.64
|
|
Height Velocity
Month 24 (n=37, 41)
|
4.9 centimeter per year
Standard Deviation 1.33
|
7.8 centimeter per year
Standard Deviation 3.36
|
|
Height Velocity
Month 36 (n=18, 19)
|
6.6 centimeter per year
Standard Deviation 3.25
|
3.5 centimeter per year
Standard Deviation 2.71
|
|
Height Velocity
Month 42 (n=13, 14)
|
5.7 centimeter per year
Standard Deviation 1.94
|
3.7 centimeter per year
Standard Deviation 2.17
|
|
Height Velocity
Month 48 (n=7, 8)
|
5.4 centimeter per year
Standard Deviation 2.27
|
2.9 centimeter per year
Standard Deviation 2.73
|
|
Height Velocity
Month 54 (n=1, 1)
|
6.3 centimeter per year
Standard Deviation 0
|
7.1 centimeter per year
Standard Deviation 0
|
|
Height Velocity
Safety follow up 6 months (n=16, 9)
|
4.6 centimeter per year
Standard Deviation 2.08
|
4.5 centimeter per year
Standard Deviation 2.45
|
|
Height Velocity
Safety follow up 12 months(n=15, 8)
|
2.9 centimeter per year
Standard Deviation 2.37
|
2.3 centimeter per year
Standard Deviation 1.43
|
|
Height Velocity
Safety follow up 18 months (n=12, 4)
|
3.3 centimeter per year
Standard Deviation 1.69
|
1.2 centimeter per year
Standard Deviation 1.20
|
|
Height Velocity
Safety follow up 24 months (n=9, 1)
|
2.0 centimeter per year
Standard Deviation 1.32
|
2.5 centimeter per year
Standard Deviation 0
|
|
Height Velocity
Safety follow up 36 months (n=5, 0)
|
1.3 centimeter per year
Standard Deviation 0.53
|
0 centimeter per year
Standard Deviation 0
|
|
Height Velocity
Safety follow up 42 months (n=2, 0)
|
2.1 centimeter per year
Standard Deviation 2.45
|
0 centimeter per year
Standard Deviation 0
|
|
Height Velocity
Safety follow up 12 months (final height)(n=18,14)
|
0.5 centimeter per year
Standard Deviation 0.86
|
0.8 centimeter per year
Standard Deviation 1.59
|
|
Height Velocity
Safety follow up 24 months (final height) (n=7,10)
|
0.3 centimeter per year
Standard Deviation 0.77
|
0.3 centimeter per year
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Baseline through End of Study (up to 9 years)Population: All participants who received at least one dose of study drug with at least one follow up visit. The safety follow up participants did not reach final height at end of Period 1 unless final height is noted for participants that reached final height at the end of Period 1.
SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Outcome measures
| Measure |
Somatropin and Leuprorelin
n=45 Participants
0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
|
Somatropin
n=43 Participants
0.05mg/kg/day subcutaneous somatropin only
|
|---|---|---|
|
Height SDS
Safety follow up 36 months (final height) (n=3,7)
|
-1.2 standard deviation score
Standard Deviation 0.90
|
-2.2 standard deviation score
Standard Deviation 0.94
|
|
Height SDS
Randomization (n=45, 43)
|
-2.5 standard deviation score
Standard Deviation 0.45
|
-2.5 standard deviation score
Standard Deviation 0.46
|
|
Height SDS
Month 3 (n=45, 43)
|
-2.4 standard deviation score
Standard Deviation 0.42
|
-2.4 standard deviation score
Standard Deviation 0.47
|
|
Height SDS
Month 6 (n=45, 42)
|
-2.3 standard deviation score
Standard Deviation 0.48
|
-2.2 standard deviation score
Standard Deviation 0.52
|
|
Height SDS
Month 12 (n=44, 42)
|
-2.2 standard deviation score
Standard Deviation 0.50
|
-2.0 standard deviation score
Standard Deviation 0.57
|
|
Height SDS
Month 18 (n=42, 42)
|
-2.2 standard deviation score
Standard Deviation 0.53
|
-1.9 standard deviation score
Standard Deviation 0.63
|
|
Height SDS
Month 24 (n=37, 41)
|
-2.3 standard deviation score
Standard Deviation 0.58
|
-1.8 standard deviation score
Standard Deviation 0.67
|
|
Height SDS
Month 30 (n=25, 25)
|
-2.2 standard deviation score
Standard Deviation 0.63
|
-2.0 standard deviation score
Standard Deviation 0.58
|
|
Height SDS
Month 36 (n=18, 19)
|
-2.0 standard deviation score
Standard Deviation 0.65
|
-2.0 standard deviation score
Standard Deviation 0.68
|
|
Height SDS
Month 42 (n=13, 14)
|
-1.8 standard deviation score
Standard Deviation 0.68
|
-1.9 standard deviation score
Standard Deviation 0.66
|
|
Height SDS
Month 48 (n=7, 8)
|
-1.6 standard deviation score
Standard Deviation 0.52
|
-1.9 standard deviation score
Standard Deviation 0.65
|
|
Height SDS
Month 54 (n=1, 1)
|
-1.0 standard deviation score
Standard Deviation 0
|
-1.7 standard deviation score
Standard Deviation 0
|
|
Height SDS
Safety follow up 6 months (n=16, 9)
|
-2.1 standard deviation score
Standard Deviation 0.65
|
-1.7 standard deviation score
Standard Deviation 0.77
|
|
Height SDS
Safety follow up 12 months(n=15, 8)
|
-1.9 standard deviation score
Standard Deviation 0.55
|
-1.7 standard deviation score
Standard Deviation 0.77
|
|
Height SDS
Safety follow up 18 months (n=12, 4)
|
-1.9 standard deviation score
Standard Deviation 0.63
|
-1.9 standard deviation score
Standard Deviation 0.78
|
|
Height SDS
Safety follow up 24 months (n=9, 1)
|
-1.9 standard deviation score
Standard Deviation 0.46
|
-1.2 standard deviation score
Standard Deviation 0
|
|
Height SDS
Safety follow up 36 months (n=5, 0)
|
-1.9 standard deviation score
Standard Deviation 0.67
|
0 standard deviation score
Standard Deviation 0
|
|
Height SDS
Safety follow up 42 months (n=2, 0)
|
-2.4 standard deviation score
Standard Deviation 0.18
|
0 standard deviation score
Standard Deviation 0
|
|
Height SDS
Safety follow up 12 months (final height)(n=18,14)
|
-1.9 standard deviation score
Standard Deviation 0.46
|
-1.8 standard deviation score
Standard Deviation 0.71
|
|
Height SDS
Safety follow up 24 months (final height) (n=7,10)
|
-1.6 standard deviation score
Standard Deviation 0.56
|
-2.0 standard deviation score
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Baseline through End of Study (up to 9 years)Population: All participants who received who reached final height.
This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of target height \[calculated as (mother's height (SDS) + father's height (SDS))/2\] for particular participant. The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Outcome measures
| Measure |
Somatropin and Leuprorelin
n=16 Participants
0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
|
Somatropin
n=15 Participants
0.05mg/kg/day subcutaneous somatropin only
|
|---|---|---|
|
Difference Between Adult Height SDS and Target Height SDS
|
-0.6 standard deviation score
Standard Deviation 0.89
|
-1.2 standard deviation score
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: Baseline through End up Study (up to 9 years)Population: All participants who received who reached final height.
This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of baseline predicted height \[calculated using the Bayley-Pinneau method based on height and bone age\] for particular participant. The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Outcome measures
| Measure |
Somatropin and Leuprorelin
n=18 Participants
0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
|
Somatropin
n=16 Participants
0.05mg/kg/day subcutaneous somatropin only
|
|---|---|---|
|
Difference Between Adult Height SDS and Baseline Predicted Height SDS
|
1.1 standard deviation score
Standard Deviation 0.96
|
1.2 standard deviation score
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Baseline through End up Study (up to 9 years)Population: All participants who received who reached final height.
This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of baseline height for particular participant. The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Outcome measures
| Measure |
Somatropin and Leuprorelin
n=19 Participants
0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
|
Somatropin
n=16 Participants
0.05mg/kg/day subcutaneous somatropin only
|
|---|---|---|
|
Difference Between Adult Height SDS and Baseline Height SDS
|
0.6 standard deviation score
Standard Deviation 0.59
|
0.6 standard deviation score
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: Baseline through End of Study (up to 9 years)Population: All participants who received at least one dose of study drug with at least one follow up visit.
Percentage of children with normal adult height SDS (greater than -2 SDS and less than +2 SDS)
Outcome measures
| Measure |
Somatropin and Leuprorelin
n=45 Participants
0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
|
Somatropin
n=43 Participants
0.05mg/kg/day subcutaneous somatropin only
|
|---|---|---|
|
Percentage of Children With Normal Adult Height SDS
|
26.7 percentage of participants
|
25.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through End of Study (up to 9 years)Population: All participants who received at least one dose of study drug with at least one follow up visit. The safety follow up participants did not reach final height at end of Period 1 unless final height is noted for participants that reached final height at the end of Period 1.
Bone age measured using the X-Ray of left hand and wrist.
Outcome measures
| Measure |
Somatropin and Leuprorelin
n=45 Participants
0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
|
Somatropin
n=43 Participants
0.05mg/kg/day subcutaneous somatropin only
|
|---|---|---|
|
Bone Age
Randomization (n=45, 43)
|
10.8 years
Standard Deviation 1.58
|
11.0 years
Standard Deviation 1.45
|
|
Bone Age
Month 12 (n=40, 41)
|
11.7 years
Standard Deviation 1.59
|
12.1 years
Standard Deviation 1.12
|
|
Bone Age
Month 24 (n=34, 37)
|
12.4 years
Standard Deviation 1.32
|
13.4 years
Standard Deviation 1.09
|
|
Bone Age
Month 36 (n=18, 18)
|
13.3 years
Standard Deviation 1.49
|
14.5 years
Standard Deviation 1.64
|
|
Bone Age
Month 48 (n=7, 8)
|
14.8 years
Standard Deviation 1.33
|
15.4 years
Standard Deviation 1.27
|
|
Bone Age
Safety follow up 6 months (n=16, 7)
|
14.1 years
Standard Deviation 1.11
|
14.9 years
Standard Deviation 0.81
|
|
Bone Age
Safety follow up 18 months (n=12, 3)
|
15.2 years
Standard Deviation 1.25
|
17.0 years
Standard Deviation 1.00
|
|
Bone Age
Safety follow up 36 months (n=5, 0)
|
15.7 years
Standard Deviation 1.04
|
0 years
Standard Deviation 0
|
|
Bone Age
Safety follow up 12 months (final height)(n=18,14)
|
19.6 years
Standard Deviation 14.53
|
16.3 years
Standard Deviation 1.27
|
Adverse Events
Somatropin and Leuprorelin
Serious events: 12 serious events
Other events: 41 other events
Deaths: 0 deaths
Somatropin
Serious events: 7 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Somatropin and Leuprorelin
n=46 participants at risk
Somatropin and leuprorelin n=46
|
Somatropin
n=45 participants at risk
Somatropin n=45
|
|---|---|---|
|
Renal and urinary disorders
Renal colic
|
2.2%
1/46 • Number of events 1
|
0.00%
0/45
|
|
Congenital, familial and genetic disorders
Congenital genital malformation
|
0.00%
0/46
|
2.2%
1/45 • Number of events 1
|
|
Congenital, familial and genetic disorders
Thyroglossal cyst
|
2.2%
1/46 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Complication of device removal
|
2.2%
1/46 • Number of events 1
|
0.00%
0/45
|
|
Infections and infestations
Appendiceal abscess
|
2.2%
1/46 • Number of events 1
|
0.00%
0/45
|
|
Infections and infestations
Appendicitis
|
4.3%
2/46 • Number of events 2
|
4.4%
2/45 • Number of events 2
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/46
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Peritonitis
|
2.2%
1/46 • Number of events 1
|
0.00%
0/45
|
|
Infections and infestations
Viral infection
|
0.00%
0/46
|
2.2%
1/45 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
1/46 • Number of events 1
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Fracture
|
2.2%
1/46 • Number of events 1
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
2.2%
1/46 • Number of events 1
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Radius fracture
|
2.2%
1/46 • Number of events 1
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
2.2%
1/46 • Number of events 1
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
2.2%
1/46 • Number of events 1
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
2.2%
1/46 • Number of events 1
|
0.00%
0/45
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Histiocytosis
|
2.2%
1/46 • Number of events 1
|
0.00%
0/45
|
|
Nervous system disorders
Migraine
|
2.2%
1/46 • Number of events 1
|
0.00%
0/45
|
|
Psychiatric disorders
Agitation
|
0.00%
0/46
|
2.2%
1/45 • Number of events 1
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/46
|
2.2%
1/45 • Number of events 1
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/46
|
2.2%
1/45 • Number of events 1
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/46
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/46
|
2.2%
1/45 • Number of events 1
|
Other adverse events
| Measure |
Somatropin and Leuprorelin
n=46 participants at risk
Somatropin and leuprorelin n=46
|
Somatropin
n=45 participants at risk
Somatropin n=45
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
2.2%
1/46 • Number of events 5
|
6.7%
3/45 • Number of events 4
|
|
Endocrine disorders
Hypothyroidism
|
2.2%
1/46 • Number of events 1
|
6.7%
3/45 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
8.7%
4/46 • Number of events 4
|
15.6%
7/45 • Number of events 18
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.5%
3/46 • Number of events 11
|
8.9%
4/45 • Number of events 10
|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
3/46 • Number of events 14
|
6.7%
3/45 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
6.5%
3/46 • Number of events 7
|
4.4%
2/45 • Number of events 3
|
|
Gastrointestinal disorders
Toothache
|
6.5%
3/46 • Number of events 7
|
0.00%
0/45
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
3/46 • Number of events 5
|
6.7%
3/45 • Number of events 5
|
|
General disorders
Injection site pain
|
17.4%
8/46 • Number of events 22
|
0.00%
0/45
|
|
General disorders
Pyrexia
|
8.7%
4/46 • Number of events 4
|
11.1%
5/45 • Number of events 6
|
|
Immune system disorders
Hypersensitivity
|
6.5%
3/46 • Number of events 3
|
0.00%
0/45
|
|
Infections and infestations
Bronchitis
|
6.5%
3/46 • Number of events 4
|
4.4%
2/45 • Number of events 2
|
|
Infections and infestations
Cystitis
|
6.5%
3/46 • Number of events 3
|
0.00%
0/45
|
|
Infections and infestations
Ear infection
|
8.7%
4/46 • Number of events 4
|
11.1%
5/45 • Number of events 8
|
|
Infections and infestations
Gastroenteritis
|
23.9%
11/46 • Number of events 15
|
13.3%
6/45 • Number of events 9
|
|
Infections and infestations
Influenza
|
32.6%
15/46 • Number of events 17
|
20.0%
9/45 • Number of events 16
|
|
Infections and infestations
Nasopharyngitis
|
41.3%
19/46 • Number of events 36
|
17.8%
8/45 • Number of events 10
|
|
Infections and infestations
Rhinitis
|
10.9%
5/46 • Number of events 5
|
6.7%
3/45 • Number of events 11
|
|
Infections and infestations
Tonsillitis
|
13.0%
6/46 • Number of events 9
|
11.1%
5/45 • Number of events 12
|
|
Infections and infestations
Tracheitis
|
4.3%
2/46 • Number of events 2
|
6.7%
3/45 • Number of events 3
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
6.5%
3/46 • Number of events 3
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
6.5%
3/46 • Number of events 3
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.2%
7/46 • Number of events 11
|
8.9%
4/45 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.7%
4/46 • Number of events 4
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
8.7%
4/46 • Number of events 4
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Headache
|
45.7%
21/46 • Number of events 51
|
35.6%
16/45 • Number of events 37
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
3/46 • Number of events 4
|
13.3%
6/45 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.5%
3/46 • Number of events 4
|
4.4%
2/45 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.9%
5/46 • Number of events 6
|
8.9%
4/45 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.3%
2/46 • Number of events 2
|
11.1%
5/45 • Number of events 7
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60