Trial Outcomes & Findings for Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN® (NCT NCT00256126)
NCT ID: NCT00256126
Last Updated: 2018-06-26
Results Overview
IGF-1 SDS was calculated using the Elmlinger reference method. Change in within subject IGF-1 levels (standard deviation scores) at Month 1 from Baseline was assessed. Descriptive statistics were determined for the Baseline and Month 1 assessments, and also for the level of change between these two assessments. If either the Baseline or Month 1 IGF-1 level was missing, then the within-subject change in IGF-1 was assumed to be missing.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
318 participants
Primary outcome timeframe
Baseline, Month 1
Results posted on
2018-06-26
Participant Flow
First informed consent date: May 2005. Clinical data cutoff date: Oct 2007, Study completion date: Sep 2007.
A total of 319 subjects were screened for this trial. Only 1 subject withdrew from the study prior to receiving the treatment due to personal reasons. Overall, 318 subjects were enrolled into the study.
Participant milestones
| Measure |
Turner Syndrome (TS)
Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
|
Growth Hormone Deficiency (GHD)
Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
|
|---|---|---|
|
Overall Study
STARTED
|
149
|
169
|
|
Overall Study
COMPLETED
|
147
|
167
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Turner Syndrome (TS)
Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
|
Growth Hormone Deficiency (GHD)
Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Other
|
1
|
2
|
Baseline Characteristics
Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®
Baseline characteristics by cohort
| Measure |
Turner Syndrome (TS)
n=149 Participants
Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
|
Growth Hormone Deficiency (GHD)
n=169 Participants
Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
|
Total
n=318 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.3 years
STANDARD_DEVIATION 4.08 • n=5 Participants
|
8.94 years
STANDARD_DEVIATION 3.17 • n=7 Participants
|
9.11 years
STANDARD_DEVIATION 3.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 1Population: The Intention to Treat (ITT) population included all subjects who received at least 1 dose of study medication. Here "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure.
IGF-1 SDS was calculated using the Elmlinger reference method. Change in within subject IGF-1 levels (standard deviation scores) at Month 1 from Baseline was assessed. Descriptive statistics were determined for the Baseline and Month 1 assessments, and also for the level of change between these two assessments. If either the Baseline or Month 1 IGF-1 level was missing, then the within-subject change in IGF-1 was assumed to be missing.
Outcome measures
| Measure |
Turner Syndrome (TS)
n=143 Participants
Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
|
Growth Hormone Deficiency (GHD)
n=162 Participants
Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
|
|---|---|---|
|
Change From Baseline in Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) at Month 1
|
1.7692 Standard deviation score (SDS)
Standard Deviation 1.1889
|
1.4007 Standard deviation score (SDS)
Standard Deviation 0.9811
|
SECONDARY outcome
Timeframe: Baseline, Month 1Population: The ITT population included all subjects who received at least 1 dose of study medication. Here "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure.
Outcome measures
| Measure |
Turner Syndrome (TS)
n=143 Participants
Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
|
Growth Hormone Deficiency (GHD)
n=162 Participants
Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
|
|---|---|---|
|
Change From Baseline in Insulin-like Growth Factor Binding Protein - 3 (IGFBP-3) Level at Month 1
|
0.86 milligram per liter (mg/L)
Standard Deviation 0.96
|
0.69 milligram per liter (mg/L)
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Baseline, Month 1Population: The ITT population included all subjects who received at least 1 dose of study medication. Here "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure.
Outcome measures
| Measure |
Turner Syndrome (TS)
n=122 Participants
Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
|
Growth Hormone Deficiency (GHD)
n=142 Participants
Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
|
|---|---|---|
|
Change From Baseline in Fasting Glucose Levels at Month 1
|
0.22 millimoles per liter (mmol/L)
Standard Deviation 0.8
|
0.13 millimoles per liter (mmol/L)
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: Baseline, Month 1Population: The ITT population included all subjects who received at least 1 dose of study medication. Here "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure.
Outcome measures
| Measure |
Turner Syndrome (TS)
n=142 Participants
Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
|
Growth Hormone Deficiency (GHD)
n=160 Participants
Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
|
|---|---|---|
|
Change From Baseline in Fasting Insulin Levels at Month 1
|
47.7 picomole per liter (pmol/L)
Standard Deviation 177.2
|
26.9 picomole per liter (pmol/L)
Standard Deviation 79.8
|
SECONDARY outcome
Timeframe: Baseline, Month 1Population: The ITT population included all subjects who received at least 1 dose of study medication. Here "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure.
HOMA-IR is used to assess insulin resistance and calculated by an empirical mathematical formula based on fasting plasma glucose and fasting plasma insulin levels. HOMA-IR = fasting plasma insulin (picomole/liter \[pmol/L\]) \* fasting plasma glucose (millimole/liter \[mmol/L\]) divided by 22.5.
Outcome measures
| Measure |
Turner Syndrome (TS)
n=120 Participants
Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
|
Growth Hormone Deficiency (GHD)
n=136 Participants
Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
|
|---|---|---|
|
Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Month 1
|
2.132 picomole per liter *millimole per liter
Standard Deviation 10.296
|
1.061 picomole per liter *millimole per liter
Standard Deviation 3.885
|
SECONDARY outcome
Timeframe: Baseline, Month 1Population: The ITT population included all subjects who received at least 1 dose of study medication. Here "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure.
Outcome measures
| Measure |
Turner Syndrome (TS)
n=144 Participants
Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
|
Growth Hormone Deficiency (GHD)
n=162 Participants
Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
|
|---|---|---|
|
Change From Baseline in Bone Alkaline Phosphatase Levels at Month 1
|
21.13 Units per liter (U/L)
Standard Deviation 80.68
|
14.78 Units per liter (U/L)
Standard Deviation 25.23
|
Adverse Events
Turner Syndrome (TS)
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Growth Hormone Deficiency (GHD)
Serious events: 1 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Turner Syndrome (TS)
n=149 participants at risk
Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
|
Growth Hormone Deficiency (GHD)
n=169 participants at risk
Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
|
|---|---|---|
|
Infections and infestations
Tonsillitis streptococcal
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
Other adverse events
| Measure |
Turner Syndrome (TS)
n=149 participants at risk
Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
|
Growth Hormone Deficiency (GHD)
n=169 participants at risk
Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
|
|---|---|---|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
General disorders
Pyrexia
|
4.0%
6/149 • Number of events 7 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
5.3%
9/169 • Number of events 9 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
General disorders
Injection site haemorrhage
|
0.67%
1/149 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
General disorders
Injection site irritation
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 2 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
General disorders
Fatigue
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
General disorders
Influenza like illness
|
0.67%
1/149 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.00%
0/169 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
General disorders
Injection site anaesthesia
|
0.67%
1/149 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.00%
0/169 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Psychiatric disorders
Affect lability
|
0.67%
1/149 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.00%
0/169 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 2 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
5/149 • Number of events 7 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
1.2%
2/169 • Number of events 2 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.0%
3/149 • Number of events 5 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.00%
0/169 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.67%
1/149 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.67%
1/149 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.00%
0/169 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.67%
1/149 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.00%
0/169 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Nervous system disorders
Headache
|
5.4%
8/149 • Number of events 10 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
7.1%
12/169 • Number of events 18 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Nervous system disorders
Dizziness
|
1.3%
2/149 • Number of events 3 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 2 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Ear and labyrinth disorders
Vertigo
|
0.67%
1/149 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Ear and labyrinth disorders
Ear pain
|
0.67%
1/149 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.00%
0/169 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
3/149 • Number of events 3 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
2.4%
4/169 • Number of events 4 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.67%
1/149 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
1.8%
3/169 • Number of events 3 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 2 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Endocrine disorders
Precocious puberty
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Infections and infestations
Nasopharyngitis
|
2.7%
4/149 • Number of events 4 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
1.2%
2/169 • Number of events 2 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
3/149 • Number of events 4 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
1.2%
2/169 • Number of events 2 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Infections and infestations
Gastroenteritis
|
0.67%
1/149 • Number of events 2 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
1.2%
2/169 • Number of events 2 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Infections and infestations
Ear infection
|
1.3%
2/149 • Number of events 2 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.00%
0/169 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Infections and infestations
Influenza
|
0.67%
1/149 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
1.2%
2/169 • Number of events 2 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Infections and infestations
Tonsillitis
|
0.67%
1/149 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Infections and infestations
Bronchitis acute
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Infections and infestations
Otitis externa
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Infections and infestations
Skin infection
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/149 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months).
|
Additional Information
Merck KGaA Communication Center
Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER