Trial Outcomes & Findings for Study to Define Optimal IGF-1 Monitoring in Children Treated With NutropinAq (NCT NCT00234533)
NCT ID: NCT00234533
Last Updated: 2019-12-09
Results Overview
Fingertip capillary blood was collected using filter paper cards for the assay of capillary blood spot IGF-I in line with the monitoring recommendations of the Lawson Wilkins Paediatric Endocrine Society (LWPES) for treatment with recombinant GH therapy in children. Capillary IGF-I assays were performed by the patient at home one day per week during Weeks 21, 22 and 23 only (same week day). The samples were scheduled in the evening prior to the injection of NutropinAq and between 7:00 and 9:00 the following morning. An extended window from 6:00 to 12:00 was allowed for defining protocol deviations. The number of capillary blood spot IGF-I measurements and the optimal timing of samples to assess the IGF-I status of NutropinAq treated patients was assessed. IGF-I measurements for the morning and evening sampling are presented.
COMPLETED
PHASE3
251 participants
At Weeks 21, 22 and 23
2019-12-09
Participant Flow
251 children presenting growth failure associated with Growth Hormone Deficiency (GHD), Turner Syndrome (TS) or Chronic Renal Insufficiency (CRI) were screened (with informed consent) in 46 study centers across Europe. First patient enrolled: 7 June 2004; last subject completed: 22 July 2008
Of the 251 children screened 3 did not receive study medication, 1 due to withdrawal of consent, 1 did not meet screening criteria for height and 1 was not included due to the investigator's decision.
Participant milestones
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
Patients received daily subcutaneous (s.c.) injections of NutropinAq 10 milligrams (mg)/ 2 milliliters (mL) for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/ kilogram (kg) bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
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|---|---|
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Overall Study
STARTED
|
251
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Overall Study
COMPLETED
|
240
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|
Overall Study
NOT COMPLETED
|
11
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Reasons for withdrawal
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
Patients received daily subcutaneous (s.c.) injections of NutropinAq 10 milligrams (mg)/ 2 milliliters (mL) for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/ kilogram (kg) bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
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|---|---|
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Overall Study
Withdrawal by Subject
|
6
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Overall Study
Adverse Event
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2
|
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Overall Study
Enrolled but not treated
|
3
|
Baseline Characteristics
Data is presented for non-naïve patients only.
Baseline characteristics by cohort
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
n=244 Participants
Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/kg bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
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|---|---|
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Age, Continuous
|
9.9 years
STANDARD_DEVIATION 3.9 • n=244 Participants
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|
Sex: Female, Male
Female
|
138 Participants
n=244 Participants
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Sex: Female, Male
Male
|
106 Participants
n=244 Participants
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Birth height
|
48.49 centimeters (cm)
STANDARD_DEVIATION 3.36 • n=244 Participants
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Birth weight
|
2.94 kg
STANDARD_DEVIATION 0.60 • n=244 Participants
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|
Duration of gestation
|
38.7 weeks of amenorrhea
STANDARD_DEVIATION 2.6 • n=244 Participants
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Genetic target height
|
166.26 cm
STANDARD_DEVIATION 8.16 • n=244 Participants
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|
Calculated genetic target height Standard Deviation Score (SDS)
|
-0.33 Standard Deviations (SD)
STANDARD_DEVIATION 0.95 • n=244 Participants
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Duration of previous Growth Hormone (GH) treatment
|
1.68 years
STANDARD_DEVIATION 1.56 • n=59 Participants • Data is presented for non-naïve patients only.
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Auxological Parameter - Height
|
122.95 cm
STANDARD_DEVIATION 20.24 • n=244 Participants
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Auxological Parameter - Calculated height SDS
|
-2.68 SD
STANDARD_DEVIATION 1.33 • n=244 Participants
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|
Auxological Parameter - Weight
|
27.97 kg
STANDARD_DEVIATION 11.91 • n=244 Participants
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|
Auxological Parameter - Calculated weight SDS
|
-1.85 SD
STANDARD_DEVIATION 1.88 • n=244 Participants
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|
Auxological Parameter - Annualised Growth Velocity (GV)
|
4.94 cm/year
STANDARD_DEVIATION 2.56 • n=244 Participants
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Auxological Parameter - Calculated annualised GV SDS
|
-0.56 SD
STANDARD_DEVIATION 2.67 • n=244 Participants
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PRIMARY outcome
Timeframe: At Weeks 21, 22 and 23Population: The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data. Only evaluable subjects with an assessment at the specified timepoint were included in each individual analysis.
Fingertip capillary blood was collected using filter paper cards for the assay of capillary blood spot IGF-I in line with the monitoring recommendations of the Lawson Wilkins Paediatric Endocrine Society (LWPES) for treatment with recombinant GH therapy in children. Capillary IGF-I assays were performed by the patient at home one day per week during Weeks 21, 22 and 23 only (same week day). The samples were scheduled in the evening prior to the injection of NutropinAq and between 7:00 and 9:00 the following morning. An extended window from 6:00 to 12:00 was allowed for defining protocol deviations. The number of capillary blood spot IGF-I measurements and the optimal timing of samples to assess the IGF-I status of NutropinAq treated patients was assessed. IGF-I measurements for the morning and evening sampling are presented.
Outcome measures
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
n=244 Participants
Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/ kilogram kg bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
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|---|---|
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Insulin-Like Growth Factor I (IGF-I) Levels Measured Using the Timed Capillary Blood Spot Samples
Week 21 Morning sampling
|
223.54 nanograms/milliliter (ng/mL)
Standard Deviation 161.86
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Insulin-Like Growth Factor I (IGF-I) Levels Measured Using the Timed Capillary Blood Spot Samples
Week 21 Evening sampling
|
212.97 nanograms/milliliter (ng/mL)
Standard Deviation 153.61
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Insulin-Like Growth Factor I (IGF-I) Levels Measured Using the Timed Capillary Blood Spot Samples
Week 22 Morning sampling
|
238.02 nanograms/milliliter (ng/mL)
Standard Deviation 177.89
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Insulin-Like Growth Factor I (IGF-I) Levels Measured Using the Timed Capillary Blood Spot Samples
Week 22 Evening sampling
|
226.90 nanograms/milliliter (ng/mL)
Standard Deviation 164.38
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Insulin-Like Growth Factor I (IGF-I) Levels Measured Using the Timed Capillary Blood Spot Samples
Week 23 Morning sampling
|
241.58 nanograms/milliliter (ng/mL)
Standard Deviation 167.75
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Insulin-Like Growth Factor I (IGF-I) Levels Measured Using the Timed Capillary Blood Spot Samples
Week 23 Evening sampling
|
235.47 nanograms/milliliter (ng/mL)
Standard Deviation 168.48
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SECONDARY outcome
Timeframe: At Weeks 21, 22 and 23Population: The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.
The influence of daily and weekly timing on the IGF-I value as measured using the capillary blood spot method was analysed. A 3-way analyses of variance (ANOVA) was performed with patient, day and daily timing as factors after appropriate transformation to obtain normally distributed parameters. The interaction day\*time was tested and kept in the model only if p-value\<0.1. Parameter estimates from the statistical model are presented as least squares means for the categories of daily timing (Morning and Evening) and weekly timing (Week 21, Week 22 and Week 23). The values reported for Week 21, 22, and 23 represent the average IGF-I levels from the morning and evening samples at each week. The values reported for Evening represent the Evening IGF-I levels averaged across Weeks 21, 22, and 23, and similarly for the Morning values.
Outcome measures
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
n=244 Participants
Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/ kilogram kg bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
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|---|---|
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Assessment of IGF-I Levels: Categorised by Weekly Timing (Weeks 21-23) and Daily Timing (Morning and Evening)
Week 21
|
218.3 ng/mL
Interval 203.0 to 233.5
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|
Assessment of IGF-I Levels: Categorised by Weekly Timing (Weeks 21-23) and Daily Timing (Morning and Evening)
Week 22
|
232.4 ng/mL
Interval 217.1 to 247.8
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|
Assessment of IGF-I Levels: Categorised by Weekly Timing (Weeks 21-23) and Daily Timing (Morning and Evening)
Week 23
|
238.5 ng/mL
Interval 223.2 to 253.9
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|
Assessment of IGF-I Levels: Categorised by Weekly Timing (Weeks 21-23) and Daily Timing (Morning and Evening)
Evening
|
225.1 ng/mL
Interval 212.6 to 237.6
|
|
Assessment of IGF-I Levels: Categorised by Weekly Timing (Weeks 21-23) and Daily Timing (Morning and Evening)
Morning
|
234.4 ng/mL
Interval 221.8 to 246.9
|
SECONDARY outcome
Timeframe: At Weeks 21, 22 and 23Population: The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.
The influence of sex and prepubertal status on the IGF-I value as measured using the capillary blood spot method was analysed. Parameter estimates from the statistical model are presented as least squares means for the categories of sex (male and female) and prepubertal status (pubertal and prepubertal). The values reported represent average IGF-I levels as determined from the 6 measurements taken (i.e. morning and evening samples at Weeks 21, 22 and 23).
Outcome measures
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
n=244 Participants
Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/ kilogram kg bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
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|---|---|
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Assessment of IGF-I Levels: Categorised by Sex and Prepubertal Status
Female
|
234.4 ng/mL
Interval 224.7 to 244.4
|
|
Assessment of IGF-I Levels: Categorised by Sex and Prepubertal Status
Pubertal
|
238.9 ng/mL
Interval 224.8 to 253.5
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|
Assessment of IGF-I Levels: Categorised by Sex and Prepubertal Status
Male
|
172.1 ng/mL
Interval 162.7 to 181.9
|
|
Assessment of IGF-I Levels: Categorised by Sex and Prepubertal Status
Prepubertal
|
168.4 ng/mL
Interval 160.7 to 176.3
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SECONDARY outcome
Timeframe: Up to Week 24Population: The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data. Only evaluable subjects within each of the individual subgroups are presented for each category. As there was only 1 patient with CRI, no analysis was performed for this disease condition.
A multivariate linear regression analysis of factors on within-subject coefficient of variation (WCV) using a stepwise forward-backward elimination was used to determine the effect of individual factors on IGF-I values as measured using the capillary blood spot method (p=0.15 for a variable to enter and remain in the model). The WCV was computed from the series of 6 measurements (2 samplings in each of Weeks 21, 22 and 23). The influence of disease condition and country clusters on the IGF-I value were assessed. Country clusters: cluster 1: France; cluster 2: Spain, Greece, Romania and Italy; cluster 3: UK, Belgium, Czech Republic, Denmark, Germany, Slovakia, Austria and Finland ; cluster 4: Russia ; cluster 5: Ukraine. Parameter estimates from the statistical model presented as least squares means for categories of disease condition (GHD and TS) and location (Clusters 1, 2, 3, 4 and 5) are presented.
Outcome measures
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
n=244 Participants
Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/ kilogram kg bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
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|---|---|
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Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Disease Condition and Location
Cluster 2
|
-0.070 Regression coefficient
Standard Error 0.048
|
|
Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Disease Condition and Location
Disease condition: GHD
|
0.058 Regression coefficient
Standard Error 0.031
|
|
Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Disease Condition and Location
Disease condition: TS
|
0.000 Regression coefficient
Standard Error 0
|
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Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Disease Condition and Location
Cluster 1
|
0.014 Regression coefficient
Standard Error 0.045
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|
Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Disease Condition and Location
Cluster 3
|
-0.013 Regression coefficient
Standard Error 0.046
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Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Disease Condition and Location
Cluster 4
|
-0.059 Regression coefficient
Standard Error 0.040
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Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Disease Condition and Location
Cluster 5
|
0.000 Regression coefficient
Standard Error 0
|
SECONDARY outcome
Timeframe: Up to Week 24Population: The Per Protocol Population consisted of all patients in the ITT Population for whom no major protocol violations/deviations occurred. Only evaluable subjects within each of the individual subgroups are presented for each category.
A multivariate linear regression analysis of factors on WCV using a stepwise forward-backward elimination was used to determine the effect of individual factors on IGF-I values as measured using the capillary blood spot method (p=0.15 for a variable to enter and remain in the model). The WCV was computed from the series of 6 measurements (2 samplings in each of Weeks 21, 22 and 23). The influence of the time of the year (1st, 2nd, 3rd and 4th quarters), calculated age at enrolment and disease condition on the IGF-I value were assessed. Parameter estimates from the statistical model are presented as least squares means for the categories of time of the year (1st, 2nd, 3rd and 4th quarters), calculated age at enrolment and disease condition (GHD and TS).
Outcome measures
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
n=175 Participants
Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/ kilogram kg bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
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|---|---|
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Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Time of Year, Calculated Age at Enrolment and Disease Condition
Disease condition: TS
|
0.000 Regression coefficient
Standard Error 0
|
|
Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Time of Year, Calculated Age at Enrolment and Disease Condition
1st quarter
|
0.118 Regression coefficient
Standard Error 0.034
|
|
Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Time of Year, Calculated Age at Enrolment and Disease Condition
2nd quarter
|
0.028 Regression coefficient
Standard Error 0.033
|
|
Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Time of Year, Calculated Age at Enrolment and Disease Condition
3rd quarter
|
0.029 Regression coefficient
Standard Error 0.038
|
|
Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Time of Year, Calculated Age at Enrolment and Disease Condition
4th quarter
|
0.000 Regression coefficient
Standard Error 0
|
|
Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Time of Year, Calculated Age at Enrolment and Disease Condition
Calculated age at enrolment
|
-0.007 Regression coefficient
Standard Error 0.003
|
|
Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Time of Year, Calculated Age at Enrolment and Disease Condition
Disease condition: GHD
|
0.051 Regression coefficient
Standard Error 0.026
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data. Evaluable subjects with data available at Week 24 are presented.
3 simultaneous IGF-I measurements were taken at Weeks 0 (baseline), 12 and 24 by serum and capillary assay to determine the precision profile of the capillary blood spot method versus the serum IGF-I assay. Change from baseline at Week 24 in the IGF-I measurements by capillary blood spot method and serum assay are presented.
Outcome measures
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
n=244 Participants
Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/ kilogram kg bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
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|---|---|
|
Change From Baseline at Week 24 in the IGF-I Levels as Measured by Capillary Blood Spot Method and Serum IGF-I Assay
IGF-I Capillary blood spot method
|
123.49 ng/mL
Standard Deviation 127.40
|
|
Change From Baseline at Week 24 in the IGF-I Levels as Measured by Capillary Blood Spot Method and Serum IGF-I Assay
Serum IGF-I assay
|
215.41 ng/mL
Standard Deviation 188.03
|
SECONDARY outcome
Timeframe: Baseline to Week 12 and Week 24Population: The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data. Evaluable subjects with data available at each timepoint are presented.
The LWPES recommends that treatment for any indication with recombinant GH therapy in children be accompanied by regular monitoring of IGF-I and IGFBP3 concentrations. IGFBP3 binds circulating IGF-I and serum samples were taken at Visit 1 (Week 0), Visit 2 (Week 12) and Visit 3 (Week 24) in order to measure IGFBP3. Change from baseline (Visit 1) at Visits 2 and 3 in IGFBP3 is presented.
Outcome measures
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
n=244 Participants
Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/ kilogram kg bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
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|---|---|
|
Change From Baseline at Week 12 and Week 24 in Insulin-Like Growth Factor Binding Protein 3 (IGFBP3) Measurements
Change from baseline to Visit 2
|
1112.4 ng/mL
Standard Deviation 1321.4
|
|
Change From Baseline at Week 12 and Week 24 in Insulin-Like Growth Factor Binding Protein 3 (IGFBP3) Measurements
Change from baseline to Visit 3
|
1285.2 ng/mL
Standard Deviation 1350.9
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.
The auxological parameter, height, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). Change from baseline in measured height at Visit 3 (Week 24) for the overall ITT population is presented.
Outcome measures
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
n=244 Participants
Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/ kilogram kg bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
|
|---|---|
|
Change From Baseline at Week 24 in the Auxological Parameter Height
|
4.73 cm
Standard Deviation 1.69
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.
The auxological parameter, height, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). The French growth charts were used for the calculation of SDS parameters: the charts provide for each age range and sex a mean parameter and SD value, from which the SDS parameter can be derived assuming a normal distribution. For example: Height SDS = (height - reference mean height (age, sex)) / reference SD (age, sex). The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in SDS indicates an improvement in growth, therefore, a favorable outcome. Change from baseline in the calculated height SDS at Visit 3 (Week 24) for the overall ITT population is presented.
Outcome measures
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
n=244 Participants
Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/ kilogram kg bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
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|---|---|
|
Change From Baseline at Week 24 in the Auxological Parameter Calculated Height SDS
|
0.45 SD Score
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.
The auxological parameter, weight, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). Change from baseline in measured weight at Visit 3 (Week 24) for the overall ITT population is presented.
Outcome measures
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
n=244 Participants
Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/ kilogram kg bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
|
|---|---|
|
Change From Baseline at Week 24 in the Auxological Parameter Weight
|
2.01 kg
Standard Deviation 1.87
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.
The auxological parameter, weight, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). The French growth charts were used for the calculation of SDS parameters: the charts provide for each age range and sex a mean parameter and SD value, from which the SDS parameter can be derived assuming a normal distribution. For example: Weight SDS = (weight - reference mean weight (age, sex)) / reference SD (age, sex). The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in SDS indicates an improvement in weight, therefore, a favorable outcome. Change from baseline in the calculated weight SDS at Visit 3 (Week 24) for the overall ITT population is presented.
Outcome measures
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
n=244 Participants
Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/ kilogram kg bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
|
|---|---|
|
Change From Baseline at Week 24 in the Auxological Parameter Calculated Weight SDS
|
0.20 SD Score
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.
The auxological parameter, annualised growth velocity, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). Change from baseline in the measured annualised growth velocity at Visit 3 (Week 24) for the overall ITT population is presented.
Outcome measures
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
n=244 Participants
Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/ kilogram kg bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
|
|---|---|
|
Change From Baseline at Week 24 in the Auxological Parameter Annualised Growth Velocity
|
5.20 cm/year
Standard Deviation 4.72
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.
The auxological parameter, annualised growth velocity, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). The French growth charts were used for the calculation of SDS parameters: the charts provide for each age range and sex a mean parameter and SD value, from which the SDS parameter can be derived assuming a normal distribution. For example: Annualised GV SDS = (annualised GV - reference mean annualised GV (age, sex)) / reference SD (age, sex). The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in SDS indicates an improvement in growth velocity, therefore, a favorable outcome. Change from baseline in the annualised growth velocity SDS at Visit 3 (Week 24) for the overall ITT population is presented.
Outcome measures
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
n=244 Participants
Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/ kilogram kg bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
|
|---|---|
|
Change From Baseline at Week 24 in the Auxological Parameter Annualised Growth Velocity SDS
|
5.10 SD Score
Standard Deviation 4.80
|
SECONDARY outcome
Timeframe: At Month 5Population: The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.
The acceptability was evaluated by a questionnaire at Month 5. The users (parents and/or child) of NutropinAq pen and compliance aid booklet were asked to describe and rate the pen, cartridge, compliance aid booklet and their ease of use. The percentage of patients responding to each category for the assessment of the overall handling of the NutropinAq pen are presented. The categories are: Very easy, Easy, Moderately difficult, Difficult, Very difficult and Missing.
Outcome measures
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
n=244 Participants
Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/ kilogram kg bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
|
|---|---|
|
Percentage of Patients Rating the Overall Handling of the Administration Device, NutropinAq Pen, to Assess the Acceptability and Tolerance of NutropinAq and Its Pen
Very easy
|
39.8 Percentage of patients
|
|
Percentage of Patients Rating the Overall Handling of the Administration Device, NutropinAq Pen, to Assess the Acceptability and Tolerance of NutropinAq and Its Pen
Easy
|
52.5 Percentage of patients
|
|
Percentage of Patients Rating the Overall Handling of the Administration Device, NutropinAq Pen, to Assess the Acceptability and Tolerance of NutropinAq and Its Pen
Moderately difficult
|
3.3 Percentage of patients
|
|
Percentage of Patients Rating the Overall Handling of the Administration Device, NutropinAq Pen, to Assess the Acceptability and Tolerance of NutropinAq and Its Pen
Difficult
|
0 Percentage of patients
|
|
Percentage of Patients Rating the Overall Handling of the Administration Device, NutropinAq Pen, to Assess the Acceptability and Tolerance of NutropinAq and Its Pen
Very difficult
|
0.4 Percentage of patients
|
|
Percentage of Patients Rating the Overall Handling of the Administration Device, NutropinAq Pen, to Assess the Acceptability and Tolerance of NutropinAq and Its Pen
Missing
|
4.1 Percentage of patients
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline)Population: The Safety Population consisted of all patients who received at least one injection of treatment.
It was intended that the posology (mg/kg/day) of NutropinAq would remain constant throughout the study. The mean posology adopted at Visit 1 is presented.
Outcome measures
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
n=248 Participants
Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/ kilogram kg bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
|
|---|---|
|
Posology of NutropinAq at Baseline (Visit 1) Summarised as Mean Dose
|
0.0382 mg/kg/day
Standard Deviation 0.0092
|
SECONDARY outcome
Timeframe: Up to Week 24Population: The Safety Population consisted of all patients who received at least one injection of treatment.
The extent of treatment exposure throughout the study is presented as the mean number of daily injections performed.
Outcome measures
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
n=248 Participants
Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/ kilogram kg bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
|
|---|---|
|
Extent of Exposure to NutropinAq Throughout the Study
|
159.7 days
Standard Deviation 35.8
|
Adverse Events
NutropinAq 10 mg/2 ml (30 IU)
Serious adverse events
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
n=248 participants at risk
Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/kg bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
|
|---|---|
|
Infections and infestations
Bronchopneumonia
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Congenital, familial and genetic disorders
Retinitis Pigmentosa
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
Other adverse events
| Measure |
NutropinAq 10 mg/2 ml (30 IU)
n=248 participants at risk
Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/kg bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Cardiac disorders
Tachycardia
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Ear and labyrinth disorders
Auricular swelling
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.81%
2/248 • Number of events 2 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Endocrine disorders
Thyroiditis acute
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Eye disorders
Conjunctivitis allergic
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
4/248 • Number of events 4 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.6%
4/248 • Number of events 5 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Gastrointestinal disorders
Aptyalism
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
3/248 • Number of events 4 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Gastrointestinal disorders
Nausea
|
1.2%
3/248 • Number of events 3 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
5/248 • Number of events 8 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
General disorders
Asthenia
|
0.81%
2/248 • Number of events 3 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
General disorders
Face oedema
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
General disorders
Feeling cold
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
General disorders
Hyperthermia
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
General disorders
Injection site bruising
|
0.81%
2/248 • Number of events 2 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
General disorders
Injection site oedema
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
General disorders
Injection site pain
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
General disorders
Malaise
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
General disorders
Oedema peripheral
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
General disorders
Pyrexia
|
3.6%
9/248 • Number of events 10 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Acute sinusitis
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Bronchitis
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Bronchitis acute
|
1.2%
3/248 • Number of events 3 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Bronchopneumonia
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Cellulitis
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Ear infection
|
0.40%
1/248 • Number of events 2 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Enterovirus infection
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Influenza
|
1.2%
3/248 • Number of events 4 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.81%
2/248 • Number of events 3 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
3/248 • Number of events 3 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Otitis media
|
2.0%
5/248 • Number of events 6 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Rhinitis
|
2.4%
6/248 • Number of events 6 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Scarlet fever
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Tonsillitis
|
0.81%
2/248 • Number of events 2 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Tonsillitis bacterial
|
0.40%
1/248 • Number of events 2 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
7/248 • Number of events 10 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Viral infection
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.81%
2/248 • Number of events 2 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Investigations
Insulin-like Growth Factor increased
|
5.2%
13/248 • Number of events 13 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.40%
1/248 • Number of events 2 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
3/248 • Number of events 3 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
3/248 • Number of events 3 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.81%
2/248 • Number of events 3 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Musculoskeletal and connective tissue disorders
Pubic pain
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Nervous system disorders
Headache
|
5.6%
14/248 • Number of events 27 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Nervous system disorders
Migraine
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Renal and urinary disorders
Polyuria
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic bronchitis
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.81%
2/248 • Number of events 2 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
|
Vascular disorders
Wound haemorrhage
|
0.40%
1/248 • Number of events 1 • From baseline (Week 0) up to Week 24.
Treatment emergent adverse events are presented for the Safety Population which consisted of all patients who received at least 1 injection of treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place