Trial Outcomes & Findings for A Phase 3 Study to Evaluate the Safety and Efficacy of Saizen® in Children With Idiopathic Short Stature (ISS) (NCT NCT01746862)
NCT ID: NCT01746862
Last Updated: 2016-10-18
Results Overview
Baseline height is defined as the last available height measurement before randomization. Baseline height velocity = (\[Baseline height minus height measurement obtained at least 6 months prior\] / 6) \* 12. Height velocity at Month 6 = (\[Month 6 height minus height measurement obtained at least 6 months prior\] / 6) \* 12.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
90 participants
Primary outcome timeframe
Baseline, Month 6
Results posted on
2016-10-18
Participant Flow
Participant milestones
| Measure |
Saizen Test Group
Subjects in the Saizen test group received Saizen (recombinant-human growth hormone \[r-hGH\]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
|
Saizen Control Group
Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
30
|
|
Overall Study
Treated
|
59
|
30
|
|
Overall Study
COMPLETED
|
52
|
27
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
Reasons for withdrawal
| Measure |
Saizen Test Group
Subjects in the Saizen test group received Saizen (recombinant-human growth hormone \[r-hGH\]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
|
Saizen Control Group
Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Consent withdrawal by parent's guardian
|
5
|
2
|
|
Overall Study
Entered puberty during the study
|
1
|
0
|
Baseline Characteristics
A Phase 3 Study to Evaluate the Safety and Efficacy of Saizen® in Children With Idiopathic Short Stature (ISS)
Baseline characteristics by cohort
| Measure |
Saizen Test Group
n=59 Participants
Subjects in the Saizen test group received Saizen (recombinant-human growth hormone \[r-hGH\]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
|
Saizen Control Group
n=30 Participants
Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.79 years
STANDARD_DEVIATION 1.54 • n=99 Participants
|
6.83 years
STANDARD_DEVIATION 1.61 • n=107 Participants
|
6.80 years
STANDARD_DEVIATION 1.55 • n=206 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: Intent-to-treat (ITT) analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here "n" signifies those subjects who were evaluable for this outcome measure at the specified time points.
Baseline height is defined as the last available height measurement before randomization. Baseline height velocity = (\[Baseline height minus height measurement obtained at least 6 months prior\] / 6) \* 12. Height velocity at Month 6 = (\[Month 6 height minus height measurement obtained at least 6 months prior\] / 6) \* 12.
Outcome measures
| Measure |
Saizen Test Group
n=60 Participants
Subjects in the Saizen test group received Saizen (recombinant-human growth hormone \[r-hGH\]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
|
Saizen Control Group
n=30 Participants
Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
|
|---|---|---|
|
Change From Baseline in Height Velocity at Month 6 Using Last Observation Carried Forward (LOCF) Method
Baseline (n=59,30)
|
5.63 centimeter/year (cm/yr)
Standard Deviation 1.62
|
4.94 centimeter/year (cm/yr)
Standard Deviation 1.91
|
|
Change From Baseline in Height Velocity at Month 6 Using Last Observation Carried Forward (LOCF) Method
Change at Month 6 (n=59,29)
|
4.45 centimeter/year (cm/yr)
Standard Deviation 2.70
|
1.01 centimeter/year (cm/yr)
Standard Deviation 3.15
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.
Baseline height is defined as the last available height measurement before randomization. Baseline height velocity = (\[Baseline height minus height measurement obtained at least 12 months prior\] / 12) \* 12. Height velocity at Month 12 = (\[Month 12 height minus height measurement obtained at least 12 months prior\] / 12) \* 12.
Outcome measures
| Measure |
Saizen Test Group
n=52 Participants
Subjects in the Saizen test group received Saizen (recombinant-human growth hormone \[r-hGH\]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
|
Saizen Control Group
n=27 Participants
Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
|
|---|---|---|
|
Change From Baseline in Height Velocity at Month 12
|
3.77 cm/year
Standard Deviation 2.21
|
2.86 cm/year
Standard Deviation 1.95
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12Population: ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here "n" signifies those subjects who were evaluable for this outcome measure at the specified time points.
Outcome measures
| Measure |
Saizen Test Group
n=60 Participants
Subjects in the Saizen test group received Saizen (recombinant-human growth hormone \[r-hGH\]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
|
Saizen Control Group
n=30 Participants
Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
|
|---|---|---|
|
Change From Baseline in Height at Month 6 and 12
Baseline (n=60, 30)
|
108.27 centimeter (cm)
Standard Deviation 7.67
|
108.07 centimeter (cm)
Standard Deviation 8.36
|
|
Change From Baseline in Height at Month 6 and 12
Change at Month 6 (n=55, 27)
|
5.41 centimeter (cm)
Standard Deviation 1.04
|
3.10 centimeter (cm)
Standard Deviation 0.84
|
|
Change From Baseline in Height at Month 6 and 12
Change at Month 12 (n=52, 27)
|
9.78 centimeter (cm)
Standard Deviation 1.35
|
8.24 centimeter (cm)
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12Population: ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here "n" signifies those subjects who were evaluable for this outcome measure at the specified time points.
Height SDS was calculated as: Height SDS = (measured height - population mean) / population standard deviation, where mean and standard deviation were based on the Korean standard growth charts. SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) a subject's value was relative to the mean of the reference population. The scores were centred around zero. Negative score indicated a subject was smaller for their age/gender.
Outcome measures
| Measure |
Saizen Test Group
n=60 Participants
Subjects in the Saizen test group received Saizen (recombinant-human growth hormone \[r-hGH\]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
|
Saizen Control Group
n=30 Participants
Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
|
|---|---|---|
|
Change From Baseline in Height Standard Deviation Score (SDS) at Month 6 and 12
Baseline (n=60,30)
|
-2.26 standard deviation score
Standard Deviation 0.36
|
-2.34 standard deviation score
Standard Deviation 0.34
|
|
Change From Baseline in Height Standard Deviation Score (SDS) at Month 6 and 12
Change at Month 6 (n=55, 27)
|
0.59 standard deviation score
Standard Deviation 0.21
|
0.08 standard deviation score
Standard Deviation 0.19
|
|
Change From Baseline in Height Standard Deviation Score (SDS) at Month 6 and 12
Change at Month 12 (n=52, 27)
|
0.96 standard deviation score
Standard Deviation 0.27
|
0.62 standard deviation score
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12Population: ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here "n" signifies those subjects who were evaluable for this outcome measure at the specified time points.
Outcome measures
| Measure |
Saizen Test Group
n=60 Participants
Subjects in the Saizen test group received Saizen (recombinant-human growth hormone \[r-hGH\]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
|
Saizen Control Group
n=30 Participants
Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
|
|---|---|---|
|
Change From Baseline in Serum Concentration of Insulin-like Growth Factor-I (IGF-I) at Month 6 and 12
Baseline (n=60,30)
|
112.62 microgram/liter (mcg/L)
Standard Deviation 43.06
|
125.01 microgram/liter (mcg/L)
Standard Deviation 65.68
|
|
Change From Baseline in Serum Concentration of Insulin-like Growth Factor-I (IGF-I) at Month 6 and 12
Change at Month 12 (n=52, 27)
|
164.48 microgram/liter (mcg/L)
Standard Deviation 95.69
|
142.17 microgram/liter (mcg/L)
Standard Deviation 112.94
|
|
Change From Baseline in Serum Concentration of Insulin-like Growth Factor-I (IGF-I) at Month 6 and 12
Change at Month 6 (n=55, 27)
|
122.57 microgram/liter (mcg/L)
Standard Deviation 96.99
|
8.30 microgram/liter (mcg/L)
Standard Deviation 41.57
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12Population: ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here "n" signifies those subjects who were evaluable for this outcome measure at the specified time points.
Outcome measures
| Measure |
Saizen Test Group
n=60 Participants
Subjects in the Saizen test group received Saizen (recombinant-human growth hormone \[r-hGH\]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
|
Saizen Control Group
n=30 Participants
Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
|
|---|---|---|
|
Change From Baseline in Serum Concentration of Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) at Month 6 and 12
Baseline (n=60, 30)
|
3,783.33 mcg/L
Standard Deviation 915.20
|
3,935.67 mcg/L
Standard Deviation 866.42
|
|
Change From Baseline in Serum Concentration of Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) at Month 6 and 12
Change at Month 6 (n=55, 27)
|
857.64 mcg/L
Standard Deviation 761.28
|
-38.89 mcg/L
Standard Deviation 616.88
|
|
Change From Baseline in Serum Concentration of Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) at Month 6 and 12
Change at Month 12 (n=52, 27)
|
932.31 mcg/L
Standard Deviation 666.13
|
545.56 mcg/L
Standard Deviation 599.52
|
SECONDARY outcome
Timeframe: 6 months post-dose (Saizen Test Group and Saizen Control Group); 12 months post-dose (Saizen Test Group)Population: ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here "n" signifies those subjects who were evaluable for this outcome measure at the specified time points.
Percentage of adherence to study treatment (adherence rate) was defined as the actual number of received treatments divided by the scheduled number of treatments multiplied by 100. The adherence rate for 6 months was calculated from Baseline to 6 months for the Saizen Test Group and from Month 6 to Month 12 for the Saizen Control Group.
Outcome measures
| Measure |
Saizen Test Group
n=60 Participants
Subjects in the Saizen test group received Saizen (recombinant-human growth hormone \[r-hGH\]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
|
Saizen Control Group
n=30 Participants
Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
|
|---|---|---|
|
Percentage of Adherence to Study Treatment
Adherence for 6 months (n=60, 27)
|
94.38 percentage of adherance
Standard Deviation 14.12
|
95.69 percentage of adherance
Standard Deviation 5.04
|
|
Percentage of Adherence to Study Treatment
Adherence for 12 months (n=60, 0)
|
93.27 percentage of adherance
Standard Deviation 14.67
|
NA percentage of adherance
Standard Deviation NA
Data was not available as control group received the treatment for only 6 months
|
SECONDARY outcome
Timeframe: Baseline up to Month 13Population: Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. For the Saizen Test Group, TEAEs were defined as events that occurred or worsened at or after the first administration of treatment and for the Saizen Control Group, TEAEs were defined as events that occurred or worsened at or after the randomization.
Outcome measures
| Measure |
Saizen Test Group
n=59 Participants
Subjects in the Saizen test group received Saizen (recombinant-human growth hormone \[r-hGH\]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
|
Saizen Control Group
n=30 Participants
Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
|
|---|---|---|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs
TEAEs
|
42 subjects
|
18 subjects
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs
Serious TEAEs
|
3 subjects
|
1 subjects
|
Adverse Events
Saizen Test Group
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Saizen Control Group
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Saizen Test Group
n=59 participants at risk
Subjects in the Saizen test group received Saizen (recombinant-human growth hormone \[r-hGH\]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
|
Saizen Control Group
n=30 participants at risk
Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
|
|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Chronic tonsillitis
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Croup infectious
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
3.4%
2/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.00%
0/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
Other adverse events
| Measure |
Saizen Test Group
n=59 participants at risk
Subjects in the Saizen test group received Saizen (recombinant-human growth hormone \[r-hGH\]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
|
Saizen Control Group
n=30 participants at risk
Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
|
|---|---|---|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Congenital, familial and genetic disorders
Pectus carinatum
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Eye disorders
Chalazion
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Eye disorders
Eye inflammation
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
General disorders
Pyrexia
|
6.8%
4/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
10.0%
3/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
2/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Gastrointestinal disorders
Enteritis
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Gastrointestinal disorders
Colitis
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Gastrointestinal disorders
Oral mucosal eruption
|
0.00%
0/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Nasopharyngitis
|
40.7%
24/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
30.0%
9/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Upper respiratory tract infection
|
23.7%
14/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
30.0%
9/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Rhinitis
|
6.8%
4/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
6.7%
2/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Bronchitis
|
3.4%
2/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
10.0%
3/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Conjunctivitis
|
6.8%
4/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Gastroenteritis
|
6.8%
4/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Otitis media
|
3.4%
2/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
6.7%
2/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Influenza
|
3.4%
2/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Pharyngitis
|
3.4%
2/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Acute tonsillitis
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Hordeolum
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Impetigo
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Molluscum contagiosum
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Otitis media acute
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Perineal infection
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Pulpitis dental
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Tinea infection
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Tonsillitis
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Tooth abscess
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Tracheitis
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Infections and infestations
Varicella
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Investigations
Haemoglobin decreased
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Nervous system disorders
Headache
|
0.00%
0/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Reproductive system and breast disorders
Breast mass
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.1%
3/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
6.7%
2/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
0.00%
0/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.4%
2/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
1/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/59 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
3.3%
1/30 • Baseline up to Month 13
Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.
|
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