Trial Outcomes & Findings for Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children (NCT NCT02968004)
NCT ID: NCT02968004
Last Updated: 2025-07-20
Results Overview
Annual Height Velocity in cm. Annual Height Velocity at 12 months is based on the difference between the heights at 12 months and baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
224 participants
Primary outcome timeframe
52 weeks
Results posted on
2025-07-20
Participant Flow
Participant milestones
| Measure |
MOD-4023
Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.
Note that in the OLE Phase of the study all subjects were treated with MOD-4023. The distribution noted across different arms is in reference to the assigned drug during the Main Study Phase.
|
Genotropin
Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)
Somatropin: Once daily subcutaneous injection of Genotropin
Note that in the OLE Phase of the study all subjects were treated with MOD-4023. The distribution noted across different arms is in reference to the assigned drug during the Main Study Phase.
|
|---|---|---|
|
Main Study Phase
STARTED
|
109
|
115
|
|
Main Study Phase
COMPLETED
|
108
|
114
|
|
Main Study Phase
NOT COMPLETED
|
1
|
1
|
|
Open Label Extension (OLE) Year 1
STARTED
|
104
|
108
|
|
Open Label Extension (OLE) Year 1
COMPLETED
|
102
|
99
|
|
Open Label Extension (OLE) Year 1
NOT COMPLETED
|
2
|
9
|
|
Open Label Extension (OLE) Year 2
STARTED
|
91
|
86
|
|
Open Label Extension (OLE) Year 2
COMPLETED
|
88
|
82
|
|
Open Label Extension (OLE) Year 2
NOT COMPLETED
|
3
|
4
|
|
Open Label Extension (OLE) Year 3
STARTED
|
88
|
82
|
|
Open Label Extension (OLE) Year 3
COMPLETED
|
84
|
80
|
|
Open Label Extension (OLE) Year 3
NOT COMPLETED
|
4
|
2
|
|
Open Label Extension (OLE) Year 4
STARTED
|
83
|
79
|
|
Open Label Extension (OLE) Year 4
COMPLETED
|
38
|
43
|
|
Open Label Extension (OLE) Year 4
NOT COMPLETED
|
45
|
36
|
|
Open Label Extension (OLE) Year 5
STARTED
|
24
|
28
|
|
Open Label Extension (OLE) Year 5
COMPLETED
|
18
|
22
|
|
Open Label Extension (OLE) Year 5
NOT COMPLETED
|
6
|
6
|
|
Open Label Extension (OLE) Year 6
STARTED
|
0
|
2
|
|
Open Label Extension (OLE) Year 6
COMPLETED
|
0
|
0
|
|
Open Label Extension (OLE) Year 6
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
MOD-4023
Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.
Note that in the OLE Phase of the study all subjects were treated with MOD-4023. The distribution noted across different arms is in reference to the assigned drug during the Main Study Phase.
|
Genotropin
Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)
Somatropin: Once daily subcutaneous injection of Genotropin
Note that in the OLE Phase of the study all subjects were treated with MOD-4023. The distribution noted across different arms is in reference to the assigned drug during the Main Study Phase.
|
|---|---|---|
|
Main Study Phase
Adverse Event
|
1
|
0
|
|
Main Study Phase
Withdrawal by Subject
|
0
|
1
|
|
Open Label Extension (OLE) Year 1
Adverse Event
|
0
|
6
|
|
Open Label Extension (OLE) Year 1
Withdrawal by Subject
|
2
|
2
|
|
Open Label Extension (OLE) Year 1
Miscellaneous
|
0
|
1
|
|
Open Label Extension (OLE) Year 2
Adverse Event
|
1
|
1
|
|
Open Label Extension (OLE) Year 2
Withdrawal by Subject
|
2
|
2
|
|
Open Label Extension (OLE) Year 2
Miscellaneous
|
0
|
1
|
|
Open Label Extension (OLE) Year 3
Adverse Event
|
1
|
0
|
|
Open Label Extension (OLE) Year 3
Withdrawal by Subject
|
2
|
1
|
|
Open Label Extension (OLE) Year 3
Prohibited Treatments
|
0
|
1
|
|
Open Label Extension (OLE) Year 3
Local Crisis
|
1
|
0
|
|
Open Label Extension (OLE) Year 4
Withdrawal by Subject
|
3
|
4
|
|
Open Label Extension (OLE) Year 4
Non-Compliance With Study Drug
|
0
|
1
|
|
Open Label Extension (OLE) Year 4
Sponsor Discontinuation of Study
|
27
|
21
|
|
Open Label Extension (OLE) Year 4
Bone Age Reached
|
3
|
1
|
|
Open Label Extension (OLE) Year 4
Local Crisis
|
10
|
9
|
|
Open Label Extension (OLE) Year 4
Miscellaneous
|
2
|
0
|
|
Open Label Extension (OLE) Year 5
Withdrawal by Subject
|
1
|
0
|
|
Open Label Extension (OLE) Year 5
Sponsor Discontinuation of Study
|
2
|
6
|
|
Open Label Extension (OLE) Year 5
Bone Age Reached,
|
1
|
0
|
|
Open Label Extension (OLE) Year 5
Closure of Epiphyseal Plates
|
1
|
0
|
|
Open Label Extension (OLE) Year 5
Local Crisis
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
Baseline characteristics by cohort
| Measure |
MOD-4023
n=109 Participants
Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.
|
Genotropin
n=115 Participants
Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)
Somatropin: Once daily subcutaneous injection of Genotropin
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.83 years
STANDARD_DEVIATION 2.66 • n=5 Participants
|
7.61 years
STANDARD_DEVIATION 2.37 • n=7 Participants
|
7.72 years
STANDARD_DEVIATION 2.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
98 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
81 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Colombia
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
25 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Belarus
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
India
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
8 participants
n=5 Participants
|
12 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
7 participants
n=5 Participants
|
12 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Georgia
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksAnnual Height Velocity in cm. Annual Height Velocity at 12 months is based on the difference between the heights at 12 months and baseline.
Outcome measures
| Measure |
MOD-4023
n=109 Participants
Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.
|
Genotropin
n=115 Participants
Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)
Somatropin: Once daily subcutaneous injection of Genotropin
|
|---|---|---|
|
Annual Height Velocity in Main Study Phase
|
10.10 cm/year
Interval 9.58 to 10.63
|
9.78 cm/year
Interval 9.29 to 10.26
|
PRIMARY outcome
Timeframe: Up to 60 monthsPopulation: Full Analysis Set
Annualized Height Velocity (cm/year) in OLE Phase
Outcome measures
| Measure |
MOD-4023
n=104 Participants
Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.
|
Genotropin
n=108 Participants
Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)
Somatropin: Once daily subcutaneous injection of Genotropin
|
|---|---|---|
|
Annual Height Velocity in OLE Phase
OLE Month 0
|
10.27 cm/year
Standard Deviation 2.38
|
9.72 cm/year
Standard Deviation 2.50
|
|
Annual Height Velocity in OLE Phase
OLE Month 12
|
8.03 cm/year
Standard Deviation 1.81
|
8.21 cm/year
Standard Deviation 1.87
|
|
Annual Height Velocity in OLE Phase
OLE Month 24
|
7.78 cm/year
Standard Deviation 1.91
|
8.05 cm/year
Standard Deviation 1.77
|
|
Annual Height Velocity in OLE Phase
OLE Month 36
|
6.90 cm/year
Standard Deviation 1.80
|
7.14 cm/year
Standard Deviation 1.69
|
|
Annual Height Velocity in OLE Phase
OLE Month 48
|
6.19 cm/year
Standard Deviation 1.62
|
6.86 cm/year
Standard Deviation 2.08
|
|
Annual Height Velocity in OLE Phase
OLE Month 60
|
—
|
5.05 cm/year
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: After 6 months of treatmentHeight velocity in cm measured after 6 months of treatment. Annualized Height velocity after 6 months is calculated based on the difference between the heights at 6 months and baseline.
Outcome measures
| Measure |
MOD-4023
n=109 Participants
Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.
|
Genotropin
n=115 Participants
Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)
Somatropin: Once daily subcutaneous injection of Genotropin
|
|---|---|---|
|
Height Velocity at 6 Months in Main Study Phase
|
10.59 cm/year
Interval 9.96 to 11.22
|
10.04 cm/year
Interval 9.47 to 10.62
|
SECONDARY outcome
Timeframe: After 6 and 12 monthsPopulation: Two subjects discontinued, one from each group.
Change in height Standard Deviation Score (SDS) after 6 and 12 months is calculated based on the difference between the heights at 6 and 12 months and baseline.
Outcome measures
| Measure |
MOD-4023
n=109 Participants
Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.
|
Genotropin
n=115 Participants
Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)
Somatropin: Once daily subcutaneous injection of Genotropin
|
|---|---|---|
|
Change in Height Standard Deviation Score (SDS) in Main Study Phase
SDS at 6 months
|
0.54 Standard Deviation Score
Interval 0.48 to 0.61
|
0.48 Standard Deviation Score
Interval 0.42 to 0.54
|
|
Change in Height Standard Deviation Score (SDS) in Main Study Phase
SDS at 12 months
|
0.92 Standard Deviation Score
Interval 0.82 to 1.02
|
0.87 Standard Deviation Score
Interval 0.78 to 0.96
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: 5 participants of MOD-4023 and 13 participants of Genotropin did not have bone age measurements at 12 months.
Annual change in bone age measurements as per Gruelich-Pyle method
Outcome measures
| Measure |
MOD-4023
n=104 Participants
Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.
|
Genotropin
n=102 Participants
Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)
Somatropin: Once daily subcutaneous injection of Genotropin
|
|---|---|---|
|
Change in Bone Maturation (BM) in Main Study Phase
|
0.05 ratio of bone age to chronologic age
Standard Deviation 0.09
|
0.06 ratio of bone age to chronologic age
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Baseline and at 12 monthsPopulation: 2 subjects in MOD-4023 and 5 subjects in Genotropin didn't have the measurements at 12 months
Via central lab analysis
Outcome measures
| Measure |
MOD-4023
n=109 Participants
Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.
|
Genotropin
n=115 Participants
Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)
Somatropin: Once daily subcutaneous injection of Genotropin
|
|---|---|---|
|
Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS) in Main Study Phase
Baseline
|
-1.95 Standard Deviation Score (SDS)
Standard Deviation 0.89
|
-1.72 Standard Deviation Score (SDS)
Standard Deviation 0.90
|
|
Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS) in Main Study Phase
At 12 months
|
0.65 Standard Deviation Score (SDS)
Standard Deviation 1.32
|
-0.69 Standard Deviation Score (SDS)
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: 60 monthsPopulation: Full Analysis Set
Change in height Standard Deviation Score (SDS) at each time point is calculated based on the difference between the time point and baseline.
Outcome measures
| Measure |
MOD-4023
n=104 Participants
Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.
|
Genotropin
n=108 Participants
Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)
Somatropin: Once daily subcutaneous injection of Genotropin
|
|---|---|---|
|
Change in Height Standard Deviation Score (SDS) in OLE Phase
Baseline (from Main Study Phase)
|
-2.95 Standard Deviation Score
Standard Deviation 1.30
|
-2.79 Standard Deviation Score
Standard Deviation 1.31
|
|
Change in Height Standard Deviation Score (SDS) in OLE Phase
OLE Month 0
|
0.95 Standard Deviation Score
Standard Deviation 0.55
|
0.85 Standard Deviation Score
Standard Deviation 0.52
|
|
Change in Height Standard Deviation Score (SDS) in OLE Phase
OLE Month 12
|
1.38 Standard Deviation Score
Standard Deviation 0.78
|
1.34 Standard Deviation Score
Standard Deviation 0.71
|
|
Change in Height Standard Deviation Score (SDS) in OLE Phase
OLE Month 24
|
1.57 Standard Deviation Score
Standard Deviation 0.77
|
1.66 Standard Deviation Score
Standard Deviation 0.78
|
|
Change in Height Standard Deviation Score (SDS) in OLE Phase
OLE Month 36
|
1.81 Standard Deviation Score
Standard Deviation 0.85
|
1.93 Standard Deviation Score
Standard Deviation 0.85
|
|
Change in Height Standard Deviation Score (SDS) in OLE Phase
OLE Month 48
|
1.96 Standard Deviation Score
Standard Deviation 0.67
|
2.04 Standard Deviation Score
Standard Deviation 0.81
|
|
Change in Height Standard Deviation Score (SDS) in OLE Phase
OLE Month 60
|
—
|
2.14 Standard Deviation Score
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: 60 MonthsPopulation: Full Analysis Set
Outcome measures
| Measure |
MOD-4023
n=104 Participants
Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.
|
Genotropin
n=108 Participants
Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)
Somatropin: Once daily subcutaneous injection of Genotropin
|
|---|---|---|
|
Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS) in OLE Phase
OLE Month 24
|
293.4 Standard Deviation Score
Standard Deviation 132.8
|
295.3 Standard Deviation Score
Standard Deviation 137.5
|
|
Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS) in OLE Phase
Baseline (from Main Study Phase)
|
77.91 Standard Deviation Score
Standard Deviation 46.11
|
83.10 Standard Deviation Score
Standard Deviation 41.17
|
|
Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS) in OLE Phase
OLE Month 0
|
185.9 Standard Deviation Score
Standard Deviation 107.1
|
69.96 Standard Deviation Score
Standard Deviation 59.92
|
|
Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS) in OLE Phase
OLE Month 12
|
255.9 Standard Deviation Score
Standard Deviation 120.0
|
248.6 Standard Deviation Score
Standard Deviation 111.9
|
|
Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS) in OLE Phase
OLE Month 36
|
315.6 Standard Deviation Score
Standard Deviation 139.7
|
330.7 Standard Deviation Score
Standard Deviation 138.0
|
|
Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS) in OLE Phase
OLE Month 48
|
354.8 Standard Deviation Score
Standard Deviation 133.1
|
368.9 Standard Deviation Score
Standard Deviation 124.9
|
|
Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS) in OLE Phase
OLE Month 60
|
—
|
397.5 Standard Deviation Score
Standard Deviation 85.27
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksProportion of successful single injections out of total number of single injections using the MOD-4023 Pen in the USA
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 weekProportion of successful single injections out of total number of single injections using the MOD-4023 Pen in the USA at Week 1 based on the Observer Assessment Tool (OAT)
Outcome measures
| Measure |
MOD-4023
n=17 Participants
Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.
|
Genotropin
Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)
Somatropin: Once daily subcutaneous injection of Genotropin
|
|---|---|---|
|
Device
|
17 Participants
|
—
|
Adverse Events
MOD-4023
Serious events: 3 serious events
Other events: 92 other events
Deaths: 0 deaths
Genotropin
Serious events: 2 serious events
Other events: 90 other events
Deaths: 0 deaths
MOD-4023 in OLE Phase
Serious events: 14 serious events
Other events: 175 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MOD-4023
n=109 participants at risk
Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.
|
Genotropin
n=115 participants at risk
Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)
Somatropin: Once daily subcutaneous injection of Genotropin
|
MOD-4023 in OLE Phase
n=212 participants at risk
Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.47%
1/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.47%
1/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Endocrine disorders
Delayed Puberty
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.47%
1/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.47%
1/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Gastrointestinal disorders
Noninfective Sialoadenitis
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.47%
1/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
1.9%
4/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Croup Infectious
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.47%
1/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.47%
1/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.47%
1/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.47%
1/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Chronic tonsillitis
|
0.92%
1/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Gastroenteritis
|
0.92%
1/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Pneumonia
|
0.92%
1/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.47%
1/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.87%
1/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.47%
1/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.87%
1/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Reproductive system and breast disorders
Scrotal Varicose Veins
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.47%
1/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal Hypertrophy
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.47%
1/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.47%
1/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Vascular disorders
Kawasaki's Disease
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.47%
1/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
Other adverse events
| Measure |
MOD-4023
n=109 participants at risk
Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.
|
Genotropin
n=115 participants at risk
Once daily subcutaneous injection of somatropin (r-hGH; Genotropin)
Somatropin: Once daily subcutaneous injection of Genotropin
|
MOD-4023 in OLE Phase
n=212 participants at risk
Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.4%
7/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
6.1%
7/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.4%
5/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Blood and lymphatic system disorders
Basophilia
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.8%
6/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
5.2%
11/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
2.8%
3/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
1.7%
2/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.47%
1/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.4%
5/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.6%
3/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.47%
1/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Ear and labyrinth disorders
Ear Pain
|
1.8%
2/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
6.1%
7/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
3.3%
7/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Endocrine disorders
Hypothyroidism
|
6.4%
7/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.6%
3/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
5.7%
12/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Eye disorders
Conjunctivitis Allergic
|
2.8%
3/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.94%
2/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Eye disorders
Myopia
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.8%
6/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.7%
4/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
1.7%
2/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
4.2%
9/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.8%
2/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
5.2%
6/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
5.7%
12/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Gastrointestinal disorders
Constipation
|
1.8%
2/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
3.5%
4/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.4%
5/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.4%
5/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
3/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
3.5%
4/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
6.6%
14/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Gastrointestinal disorders
Nausea
|
2.8%
3/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.87%
1/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.8%
6/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.8%
6/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Gastrointestinal disorders
Vomiting
|
7.3%
8/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
7.8%
9/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
10.8%
23/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
General disorders
Injection Site Erythema
|
8.3%
9/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
5.2%
11/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
General disorders
Injection Site Induration
|
3.7%
4/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.87%
1/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.94%
2/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
General disorders
Injection Site Pain
|
39.4%
43/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
25.2%
29/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
31.1%
66/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
General disorders
Injection Site Pruritus
|
5.5%
6/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.8%
6/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
General disorders
Injection Site Swelling
|
4.6%
5/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.8%
6/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
General disorders
Pyrexia
|
16.5%
18/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
13.9%
16/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
18.9%
40/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
General disorders
Vaccination Site Pain
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.4%
5/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.8%
6/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Bronchitis
|
2.8%
3/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
7.8%
9/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
7.1%
15/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Conjunctivitis
|
2.8%
3/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.6%
3/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
1.9%
4/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Corona Virus Infection
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
17.5%
37/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Enterobiasis
|
3.7%
4/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
1.7%
2/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
1.9%
4/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Gastroenteritis
|
3.7%
4/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.6%
3/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
3.8%
8/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.6%
3/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
1.9%
4/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Influenza
|
4.6%
5/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.6%
3/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
10.4%
22/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Molluscum Contagiosum
|
2.8%
3/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
1.4%
3/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Nasopharyngitis
|
22.9%
25/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
25.2%
29/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
31.1%
66/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Otitis Externa
|
3.7%
4/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
3.5%
4/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
1.4%
3/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Otitis Media
|
3.7%
4/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
6.1%
7/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
4.2%
9/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Otitis Media Acute
|
0.92%
1/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.6%
3/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
1.4%
3/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Pharyngitis
|
6.4%
7/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
4.3%
5/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
3.3%
7/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
3.3%
7/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.4%
5/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Rhinitis
|
5.5%
6/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.87%
1/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
4.7%
10/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.4%
5/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Tonsillitis
|
4.6%
5/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
5.2%
6/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.8%
6/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
3.3%
7/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.4%
5/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Viral Pharyngitis
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.4%
5/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
5.7%
12/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
5.5%
6/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.87%
1/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
1.4%
3/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.4%
5/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.4%
5/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
3.3%
7/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.8%
6/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.8%
6/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Injury, poisoning and procedural complications
Traumatic Fracture
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.4%
5/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
1.8%
2/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
7.0%
8/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
1.4%
3/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Investigations
Blood Thyroid Stimulating Hormone Decreased
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.6%
3/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.47%
1/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Investigations
Coronavirus Test Positive
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
7.1%
15/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Investigations
Free Fatty Acids Increased
|
4.6%
5/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.87%
1/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
5.2%
11/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Investigations
Insulin-Like Growth Factor Increased
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.4%
5/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Investigations
Low Density Lipoprotein Decreased
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.4%
5/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Investigations
Thyroxine Free Decreased
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
3.3%
7/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.8%
3/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
1.4%
3/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Metabolism and nutrition disorders
Hypoinsulinaemia
|
3.7%
4/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.6%
3/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.8%
6/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
0.92%
1/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.6%
3/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.94%
2/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.6%
5/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
7.0%
8/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
4.7%
10/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
4.6%
5/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
4.3%
5/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
4.7%
10/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
3.8%
8/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Nervous system disorders
Headache
|
16.5%
18/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
21.7%
25/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
19.3%
41/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Psychiatric disorders
Attention Deficit/Hyperactivity Disorder
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
3.3%
7/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
9/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
7.8%
9/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
11.3%
24/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.92%
1/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.6%
3/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
3.8%
8/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.5%
6/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
3.5%
4/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
8.5%
18/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
2.8%
3/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.87%
1/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.4%
5/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.8%
3/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
3.5%
4/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
5.7%
12/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.92%
1/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.6%
3/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.94%
2/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.8%
2/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.6%
3/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
1.9%
4/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
2.8%
3/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
1.7%
2/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/109 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
0.00%
0/115 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
2.4%
5/212 • 1 year for Main Study Phase. Up to 6 years for OLE Phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place