Trial Outcomes & Findings for Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen® (NCT NCT01187550)
NCT ID: NCT01187550
Last Updated: 2014-02-13
Results Overview
Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) was calculated as logarithm (log) 10 actual value of IGF-1 - log 10 (mean reference value of IGF-1) divided by log10 reference standard deviation of IGF-1.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
214 participants
Primary outcome timeframe
Baseline and Week 4
Results posted on
2014-02-13
Participant Flow
Out of 214 participants enrolled in the study, 1 participant could not be categorized as appropriate for gestational age (AGA) or small for gestational age (SGA) since weight and height at birth was not available.
Participant milestones
| Measure |
Appropriate for Gestational Age (AGA)
Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
|
Small for Gestational Age (SGA)
Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
183
|
30
|
|
Overall Study
Treated
|
175
|
30
|
|
Overall Study
COMPLETED
|
169
|
29
|
|
Overall Study
NOT COMPLETED
|
14
|
1
|
Reasons for withdrawal
| Measure |
Appropriate for Gestational Age (AGA)
Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
|
Small for Gestational Age (SGA)
Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
1
|
|
Overall Study
Other
|
3
|
0
|
|
Overall Study
Randomized but not treated
|
8
|
0
|
Baseline Characteristics
Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen®
Baseline characteristics by cohort
| Measure |
Appropriate for Gestational Age (AGA)
n=175 Participants
Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
|
Small for Gestational Age (SGA)
n=30 Participants
Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
|
Total
n=205 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.52 years
STANDARD_DEVIATION 3.844 • n=93 Participants
|
9.39 years
STANDARD_DEVIATION 4.349 • n=4 Participants
|
10.35 years
STANDARD_DEVIATION 3.931 • n=27 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
153 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: The intent-to-treat (ITT) population set included all the participants who received at least 1 dose of study medication.
Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) was calculated as logarithm (log) 10 actual value of IGF-1 - log 10 (mean reference value of IGF-1) divided by log10 reference standard deviation of IGF-1.
Outcome measures
| Measure |
Appropriate for Gestational Age (AGA)
n=175 Participants
Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
|
Small for Gestational Age (SGA)
n=30 Participants
Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
|
|---|---|---|
|
Change From Baseline in Serum Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) Levels at Week 4
Baseline
|
-2.04 nanogram/millilter (ng/mL)
Standard Deviation 2.341
|
-2.22 nanogram/millilter (ng/mL)
Standard Deviation 2.390
|
|
Change From Baseline in Serum Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) Levels at Week 4
Change at Week 4
|
1.38 nanogram/millilter (ng/mL)
Standard Deviation 1.358
|
0.85 nanogram/millilter (ng/mL)
Standard Deviation 1.257
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: ITT population set included all the participants who received at least 1 dose of study medication.
Outcome measures
| Measure |
Appropriate for Gestational Age (AGA)
n=175 Participants
Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
|
Small for Gestational Age (SGA)
n=30 Participants
Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
|
|---|---|---|
|
Change From Baseline in Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels at Week 4
Baseline
|
3.16 microgram/mL (mcg/mL)
Standard Deviation 1.386
|
2.57 microgram/mL (mcg/mL)
Standard Deviation 1.525
|
|
Change From Baseline in Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels at Week 4
Change at Week 4
|
0.58 microgram/mL (mcg/mL)
Standard Deviation 0.869
|
0.51 microgram/mL (mcg/mL)
Standard Deviation 0.805
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: ITT population set included all the participants who received at least 1 dose of study medication. Here 'N' (Number of participants analyzed) signified those participants who were evaluable for this measure.
Outcome measures
| Measure |
Appropriate for Gestational Age (AGA)
n=173 Participants
Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
|
Small for Gestational Age (SGA)
n=30 Participants
Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Glucose at Week 4
Baseline
|
4.83 millimole/liter (mmol/L)
Standard Deviation 0.471
|
4.46 millimole/liter (mmol/L)
Standard Deviation 1.106
|
|
Change From Baseline in Fasting Glucose at Week 4
Change at Week 4
|
0.17 millimole/liter (mmol/L)
Standard Deviation 0.578
|
0.22 millimole/liter (mmol/L)
Standard Deviation 0.886
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: ITT population set included all the participants who received at least 1 dose of study medication. Here 'N' (Number of participants analyzed) signified those participants who were evaluable for this measure.
Outcome measures
| Measure |
Appropriate for Gestational Age (AGA)
n=172 Participants
Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
|
Small for Gestational Age (SGA)
n=26 Participants
Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Insulin at Week 4
Baseline
|
36.17 picomole/L (pmol/L)
Standard Deviation 74.575
|
23.58 picomole/L (pmol/L)
Standard Deviation 14.892
|
|
Change From Baseline in Fasting Insulin at Week 4
Change at Week 4
|
10.08 picomole/L (pmol/L)
Standard Deviation 81.674
|
12.04 picomole/L (pmol/L)
Standard Deviation 32.389
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: ITT population set included all the participants who received at least 1 dose of study medication. Here 'N' (Number of participants analyzed) signified those participants who were evaluable for this 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 |
Appropriate for Gestational Age (AGA)
n=171 Participants
Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
|
Small for Gestational Age (SGA)
n=26 Participants
Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
|
|---|---|---|
|
Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Test at Week 4
Baseline
|
7.91 pmol/L*mmol/L
Standard Deviation 15.662
|
5.06 pmol/L*mmol/L
Standard Deviation 3.290
|
|
Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Test at Week 4
Change at Week 4
|
2.96 pmol/L*mmol/L
Standard Deviation 18.458
|
2.48 pmol/L*mmol/L
Standard Deviation 6.527
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: ITT population set included all the participants who received at least 1 dose of study medication. Here 'N' (Number of participants analyzed) signified those participants who were evaluable for this measure.
Total cholesterol, high-density lipoprotein (HDL)-cholesterol, low-density lipoprotein (LDL)-cholesterol and triglycerides levels were evaluated.
Outcome measures
| Measure |
Appropriate for Gestational Age (AGA)
n=174 Participants
Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
|
Small for Gestational Age (SGA)
n=30 Participants
Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
|
|---|---|---|
|
Change From Baseline in Lipid Profile at Week 4
Baseline (Total Cholesterol)
|
4.16 mmol/L
Standard Deviation 0.752
|
4.22 mmol/L
Standard Deviation 0.833
|
|
Change From Baseline in Lipid Profile at Week 4
Baseline (HDL-Cholesterol)
|
1.56 mmol/L
Standard Deviation 0.452
|
1.59 mmol/L
Standard Deviation 0.443
|
|
Change From Baseline in Lipid Profile at Week 4
Baseline (LDL-Cholesterol)
|
2.18 mmol/L
Standard Deviation 0.672
|
2.19 mmol/L
Standard Deviation 0.709
|
|
Change From Baseline in Lipid Profile at Week 4
Baseline (Triglycerides)
|
0.99 mmol/L
Standard Deviation 0.527
|
1.02 mmol/L
Standard Deviation 0.638
|
|
Change From Baseline in Lipid Profile at Week 4
Change at Week 4 (Total Cholesterol)
|
-0.28 mmol/L
Standard Deviation 0.601
|
-0.03 mmol/L
Standard Deviation 0.612
|
|
Change From Baseline in Lipid Profile at Week 4
Change at Week 4 (HDL-Cholesterol)
|
-0.10 mmol/L
Standard Deviation 0.317
|
0.02 mmol/L
Standard Deviation 0.329
|
|
Change From Baseline in Lipid Profile at Week 4
Change at Week 4 (LDL-Cholesterol)
|
-0.24 mmol/L
Standard Deviation 0.546
|
0.02 mmol/L
Standard Deviation 0.502
|
|
Change From Baseline in Lipid Profile at Week 4
Change at Week 4 (Triglycerides)
|
0.12 mmol/L
Standard Deviation 0.551
|
-0.09 mmol/L
Standard Deviation 0.831
|
Adverse Events
Appropriate for Gestational Age (AGA)
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Small for Gestational Age (SGA)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Appropriate for Gestational Age (AGA)
n=175 participants at risk
Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
|
Small for Gestational Age (SGA)
n=30 participants at risk
Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.57%
1/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
0.00%
0/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
Other adverse events
| Measure |
Appropriate for Gestational Age (AGA)
n=175 participants at risk
Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
|
Small for Gestational Age (SGA)
n=30 participants at risk
Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
|
|---|---|---|
|
Eye disorders
Conjunctivitis
|
0.57%
1/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
0.00%
0/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
|
Eye disorders
Eye Oedema
|
0.57%
1/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
0.00%
0/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
|
Eye disorders
Ocular Hypertension
|
1.1%
2/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
0.00%
0/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.57%
1/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
0.00%
0/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
|
Gastrointestinal disorders
Nausea
|
0.57%
1/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
0.00%
0/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
2/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
0.00%
0/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
|
General disorders
Hyperhidrosis
|
0.00%
0/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
3.3%
1/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
|
General disorders
Injection Site Dermatitis
|
0.57%
1/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
0.00%
0/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
|
General disorders
Injection Site Reaction
|
0.57%
1/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
0.00%
0/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
|
General disorders
Pyrexia
|
2.9%
5/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
3.3%
1/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
|
Investigations
Liver Function Test Abnormal
|
0.57%
1/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
0.00%
0/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
3.3%
1/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.57%
1/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
3.3%
1/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
|
Nervous system disorders
Headache
|
1.7%
3/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
0.00%
0/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.57%
1/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
0.00%
0/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.57%
1/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
0.00%
0/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
1.1%
2/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
0.00%
0/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.1%
2/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
0.00%
0/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillitis
|
0.57%
1/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
0.00%
0/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
2.3%
4/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
0.00%
0/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
0.57%
1/175 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
0.00%
0/30 • Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for participants who completed the study.
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
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