Trial Outcomes & Findings for Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency (NCT NCT03874013)
NCT ID: NCT03874013
Last Updated: 2021-08-12
Results Overview
Annual Height Velocity in cm/year after 12 months of treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
44 participants
Primary outcome timeframe
12 months
Results posted on
2021-08-12
Participant Flow
Participant milestones
| Measure |
MOD-4023 Treatment Arm
MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week.
MOD-4023: MOD-4023 is a long-acting modified recombinant human growth hormone (r-hGH) which utilizes C-terminal peptide (CTP) technology. It will be provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a multi-dose disposable pre-filled PEN.
MOD-4023 will be administered as a SC injection once weekly, using a delivery device.
|
Genotropin Treatment Arm
Genotropin® (reference treatment): daily Genotropin® (0.025 mg/kg/day).
Genotropin: Genotropin® is dispensed in a 2-chamber cartridge. The front compartment contains recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous. The rear compartment contains m-Cresol and mannitol in water for injections.
A delivery device (Genotropin®) will be used for daily (evening/bedtime) SC administration of Genotropin® into the region of the upper arms, buttocks, thighs or abdomen (8 locations). Injection sites should be rotated.
Dose regimen for Genotropin®: 0.025 mg/kg/day (or 0.175 mg/kg/w divided equally to 7 injections over a week).
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
MOD-4023 Treatment Arm
MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week.
MOD-4023: MOD-4023 is a long-acting modified recombinant human growth hormone (r-hGH) which utilizes C-terminal peptide (CTP) technology. It will be provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a multi-dose disposable pre-filled PEN.
MOD-4023 will be administered as a SC injection once weekly, using a delivery device.
|
Genotropin Treatment Arm
Genotropin® (reference treatment): daily Genotropin® (0.025 mg/kg/day).
Genotropin: Genotropin® is dispensed in a 2-chamber cartridge. The front compartment contains recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous. The rear compartment contains m-Cresol and mannitol in water for injections.
A delivery device (Genotropin®) will be used for daily (evening/bedtime) SC administration of Genotropin® into the region of the upper arms, buttocks, thighs or abdomen (8 locations). Injection sites should be rotated.
Dose regimen for Genotropin®: 0.025 mg/kg/day (or 0.175 mg/kg/w divided equally to 7 injections over a week).
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency
Baseline characteristics by cohort
| Measure |
MOD-4023 Treatment Arm
n=22 Participants
MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week.
MOD-4023: MOD-4023 is a long-acting modified recombinant human growth hormone (r-hGH) which utilizes C-terminal peptide (CTP) technology. It will be provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a multi-dose disposable pre-filled PEN.
MOD-4023 will be administered as a SC injection once weekly, using a delivery device.
|
Genotropin Treatment Arm
n=22 Participants
Genotropin® (reference treatment): daily Genotropin® (0.025 mg/kg/day).
Genotropin: Genotropin® is dispensed in a 2-chamber cartridge. The front compartment contains recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous. The rear compartment contains m-Cresol and mannitol in water for injections.
A delivery device (Genotropin®) will be used for daily (evening/bedtime) SC administration of Genotropin® into the region of the upper arms, buttocks, thighs or abdomen (8 locations). Injection sites should be rotated.
Dose regimen for Genotropin®: 0.025 mg/kg/day (or 0.175 mg/kg/w divided equally to 7 injections over a week).
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.28 Year
STANDARD_DEVIATION 1.84 • n=5 Participants
|
6.78 Year
STANDARD_DEVIATION 2.34 • n=7 Participants
|
6.03 Year
STANDARD_DEVIATION 2.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Weight (kilogram)
|
14.49 Kilogram
STANDARD_DEVIATION 3.33 • n=5 Participants
|
17.87 Kilogram
STANDARD_DEVIATION 4.85 • n=7 Participants
|
16.18 Kilogram
STANDARD_DEVIATION 4.45 • n=5 Participants
|
|
Body mass index (kilogram/meter^2)
|
15.27 Kilogram/meter^2
STANDARD_DEVIATION 1.30 • n=5 Participants
|
15.89 Kilogram/meter^2
STANDARD_DEVIATION 1.09 • n=7 Participants
|
15.58 Kilogram/meter^2
STANDARD_DEVIATION 1.23 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: One subject in the Genotropin arm did not finish the 12 month period and therefore not included in primary outcome.
Annual Height Velocity in cm/year after 12 months of treatment.
Outcome measures
| Measure |
MOD-4023 Treatment Arm
n=22 Participants
MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week.
MOD-4023: MOD-4023 is a long-acting modified recombinant human growth hormone (r-hGH) which utilizes C-terminal peptide (CTP) technology. It will be provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a multi-dose disposable pre-filled PEN.
MOD-4023 will be administered as a SC injection once weekly, using a delivery device.
|
Genotropin Treatment Arm
n=21 Participants
Genotropin® (reference treatment): daily Genotropin® (0.025 mg/kg/day).
Genotropin: Genotropin® is dispensed in a 2-chamber cartridge. The front compartment contains recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous. The rear compartment contains m-Cresol and mannitol in water for injections.
A delivery device (Genotropin®) will be used for daily (evening/bedtime) SC administration of Genotropin® into the region of the upper arms, buttocks, thighs or abdomen (8 locations). Injection sites should be rotated.
Dose regimen for Genotropin®: 0.025 mg/kg/day (or 0.175 mg/kg/w divided equally to 7 injections over a week).
|
|---|---|---|
|
Annual Height Velocity (HV) After 12 Months
|
9.78 cm/year
Standard Deviation 1.59
|
7.78 cm/year
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: One subject in the Genotropin arm was discontinued from treatment before the 6 month period and therefore not included in secondary outcome.
Annualized height velocity (cm/year) for the MOD-4023 and the daily hGH treatment groups
Outcome measures
| Measure |
MOD-4023 Treatment Arm
n=22 Participants
MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week.
MOD-4023: MOD-4023 is a long-acting modified recombinant human growth hormone (r-hGH) which utilizes C-terminal peptide (CTP) technology. It will be provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a multi-dose disposable pre-filled PEN.
MOD-4023 will be administered as a SC injection once weekly, using a delivery device.
|
Genotropin Treatment Arm
n=21 Participants
Genotropin® (reference treatment): daily Genotropin® (0.025 mg/kg/day).
Genotropin: Genotropin® is dispensed in a 2-chamber cartridge. The front compartment contains recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous. The rear compartment contains m-Cresol and mannitol in water for injections.
A delivery device (Genotropin®) will be used for daily (evening/bedtime) SC administration of Genotropin® into the region of the upper arms, buttocks, thighs or abdomen (8 locations). Injection sites should be rotated.
Dose regimen for Genotropin®: 0.025 mg/kg/day (or 0.175 mg/kg/w divided equally to 7 injections over a week).
|
|---|---|---|
|
Height Velocity at 6 Months
|
10.54 cm/year
Standard Deviation 2.04
|
8.34 cm/year
Standard Deviation 1.84
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: One subject in the Genotropin arm did not finish the 12 month period and therefore not included in secondary outcome.
Change in height standard deviation score (SDS) for the MOD-4023 and the daily hGH treatment groups Height Standard Deviation Score (SDS) is the number of standard deviations above or below the mean height for age and sex. Height in cm is converted to height standard deviation score (SDS) by subtracting the mean and dividing by the SD. A higher Height Standard Deviation Score (SDS) indicates a better outcome
Outcome measures
| Measure |
MOD-4023 Treatment Arm
n=22 Participants
MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week.
MOD-4023: MOD-4023 is a long-acting modified recombinant human growth hormone (r-hGH) which utilizes C-terminal peptide (CTP) technology. It will be provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a multi-dose disposable pre-filled PEN.
MOD-4023 will be administered as a SC injection once weekly, using a delivery device.
|
Genotropin Treatment Arm
n=21 Participants
Genotropin® (reference treatment): daily Genotropin® (0.025 mg/kg/day).
Genotropin: Genotropin® is dispensed in a 2-chamber cartridge. The front compartment contains recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous. The rear compartment contains m-Cresol and mannitol in water for injections.
A delivery device (Genotropin®) will be used for daily (evening/bedtime) SC administration of Genotropin® into the region of the upper arms, buttocks, thighs or abdomen (8 locations). Injection sites should be rotated.
Dose regimen for Genotropin®: 0.025 mg/kg/day (or 0.175 mg/kg/w divided equally to 7 injections over a week).
|
|---|---|---|
|
Change in Height Standard Deviation Score (SDS) Compared to Baseline After 12 Months
|
0.97 Standard Deviation Score (SDS)
Standard Deviation 0.41
|
0.50 Standard Deviation Score (SDS)
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: One subject in the Genotropin arm did not finish the 12 month period and therefore not included in secondary outcome.
Change in bone maturation (bone age / chronological age) with the method of TW2 using a central bone age reader.
Outcome measures
| Measure |
MOD-4023 Treatment Arm
n=22 Participants
MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week.
MOD-4023: MOD-4023 is a long-acting modified recombinant human growth hormone (r-hGH) which utilizes C-terminal peptide (CTP) technology. It will be provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a multi-dose disposable pre-filled PEN.
MOD-4023 will be administered as a SC injection once weekly, using a delivery device.
|
Genotropin Treatment Arm
n=21 Participants
Genotropin® (reference treatment): daily Genotropin® (0.025 mg/kg/day).
Genotropin: Genotropin® is dispensed in a 2-chamber cartridge. The front compartment contains recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous. The rear compartment contains m-Cresol and mannitol in water for injections.
A delivery device (Genotropin®) will be used for daily (evening/bedtime) SC administration of Genotropin® into the region of the upper arms, buttocks, thighs or abdomen (8 locations). Injection sites should be rotated.
Dose regimen for Genotropin®: 0.025 mg/kg/day (or 0.175 mg/kg/w divided equally to 7 injections over a week).
|
|---|---|---|
|
Change in Bone Maturation (BM) After 12 Months
|
0.05 ratio of bone age to chronologic age
Standard Deviation 0.06
|
0.03 ratio of bone age to chronologic age
Standard Deviation 0.06
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Visit 6 (Month 3), Visit 7 (Month 6), Visit 8 (Month 9) and Visit 9 (12 months)Population: One subject in the Genotropin group dropped out due to AE, so no data for 6 and 9 months.
IGF-1 Standard Deviation Score on day 4(-1) after MOD-4023 dosing across study visits (window only applies to visits 6 to 9) Height Standard Deviation Score (SDS) is the number of standard deviations above or below the mean height for age and sex. Height in cm is converted to height standard deviation score (SDS) by subtracting the mean and dividing by the SD. A higher Height Standard Deviation Score (SDS) indicates a better outcome
Outcome measures
| Measure |
MOD-4023 Treatment Arm
n=22 Participants
MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week.
MOD-4023: MOD-4023 is a long-acting modified recombinant human growth hormone (r-hGH) which utilizes C-terminal peptide (CTP) technology. It will be provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a multi-dose disposable pre-filled PEN.
MOD-4023 will be administered as a SC injection once weekly, using a delivery device.
|
Genotropin Treatment Arm
n=22 Participants
Genotropin® (reference treatment): daily Genotropin® (0.025 mg/kg/day).
Genotropin: Genotropin® is dispensed in a 2-chamber cartridge. The front compartment contains recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous. The rear compartment contains m-Cresol and mannitol in water for injections.
A delivery device (Genotropin®) will be used for daily (evening/bedtime) SC administration of Genotropin® into the region of the upper arms, buttocks, thighs or abdomen (8 locations). Injection sites should be rotated.
Dose regimen for Genotropin®: 0.025 mg/kg/day (or 0.175 mg/kg/w divided equally to 7 injections over a week).
|
|---|---|---|
|
Biochemical
Baseline
|
-1.460 Standard Deviation Score
Standard Deviation 0.902
|
-1.420 Standard Deviation Score
Standard Deviation 0.843
|
|
Biochemical
Visit 6 (Month 3)
|
0.960 Standard Deviation Score
Standard Deviation 0.770
|
-0.620 Standard Deviation Score
Standard Deviation 0.744
|
|
Biochemical
Visit 7 (Month 6)
|
1.055 Standard Deviation Score
Standard Deviation 0.834
|
-0.130 Standard Deviation Score
Standard Deviation 0.725
|
|
Biochemical
Visit 8 (Month 9)
|
1.465 Standard Deviation Score
Standard Deviation 0.953
|
-0.310 Standard Deviation Score
Standard Deviation 0.951
|
|
Biochemical
Visit 9 (Month 12)
|
1.435 Standard Deviation Score
Standard Deviation 0.921
|
-0.855 Standard Deviation Score
Standard Deviation 1.077
|
Adverse Events
MOD-4023 Treatment Arm
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Genotropin Treatment Arm
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MOD-4023 Treatment Arm
n=22 participants at risk
MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week.
MOD-4023: MOD-4023 is a long-acting modified recombinant human growth hormone (r-hGH) which utilizes C-terminal peptide (CTP) technology. It will be provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a multi-dose disposable pre-filled PEN.
MOD-4023 will be administered as a SC injection once weekly, using a delivery device.
|
Genotropin Treatment Arm
n=22 participants at risk
Genotropin® (reference treatment): daily Genotropin® (0.025 mg/kg/day).
Genotropin: Genotropin® is dispensed in a 2-chamber cartridge. The front compartment contains recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous. The rear compartment contains m-Cresol and mannitol in water for injections.
A delivery device (GenotropinÒ) will be used for daily (evening/bedtime) SC administration of Genotropin® into the region of the upper arms, buttocks, thighs or abdomen (8 locations). Injection sites should be rotated.
Dose regimen for Genotropin®: 0.025 mg/kg/day (or 0.175 mg/kg/w divided equally to 7 injections over a week).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/22 • 1 year
|
0.00%
0/22 • 1 year
|
|
Endocrine disorders
Hypoparathyroidism
|
4.5%
1/22 • 1 year
|
0.00%
0/22 • 1 year
|
|
Infections and infestations
Influenza
|
4.5%
1/22 • 1 year
|
0.00%
0/22 • 1 year
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
4.5%
1/22 • 1 year
|
0.00%
0/22 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Craniopharyngioma
|
0.00%
0/22 • 1 year
|
4.5%
1/22 • 1 year
|
|
Nervous system disorders
Febrile convulsion
|
4.5%
1/22 • 1 year
|
0.00%
0/22 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/22 • 1 year
|
4.5%
1/22 • 1 year
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/22 • 1 year
|
0.00%
0/22 • 1 year
|
Other adverse events
| Measure |
MOD-4023 Treatment Arm
n=22 participants at risk
MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week.
MOD-4023: MOD-4023 is a long-acting modified recombinant human growth hormone (r-hGH) which utilizes C-terminal peptide (CTP) technology. It will be provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a multi-dose disposable pre-filled PEN.
MOD-4023 will be administered as a SC injection once weekly, using a delivery device.
|
Genotropin Treatment Arm
n=22 participants at risk
Genotropin® (reference treatment): daily Genotropin® (0.025 mg/kg/day).
Genotropin: Genotropin® is dispensed in a 2-chamber cartridge. The front compartment contains recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous. The rear compartment contains m-Cresol and mannitol in water for injections.
A delivery device (GenotropinÒ) will be used for daily (evening/bedtime) SC administration of Genotropin® into the region of the upper arms, buttocks, thighs or abdomen (8 locations). Injection sites should be rotated.
Dose regimen for Genotropin®: 0.025 mg/kg/day (or 0.175 mg/kg/w divided equally to 7 injections over a week).
|
|---|---|---|
|
Eye disorders
Conjunctivitis allergic
|
9.1%
2/22 • 1 year
|
4.5%
1/22 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
2/22 • 1 year
|
0.00%
0/22 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
9.1%
2/22 • 1 year
|
0.00%
0/22 • 1 year
|
|
Gastrointestinal disorders
Stomatitis
|
9.1%
2/22 • 1 year
|
0.00%
0/22 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
13.6%
3/22 • 1 year
|
4.5%
1/22 • 1 year
|
|
General disorders
Injection site erythema
|
9.1%
2/22 • 1 year
|
0.00%
0/22 • 1 year
|
|
General disorders
Injection site pain
|
72.7%
16/22 • 1 year
|
13.6%
3/22 • 1 year
|
|
General disorders
Pyrexia
|
18.2%
4/22 • 1 year
|
13.6%
3/22 • 1 year
|
|
Infections and infestations
Bronchitis
|
18.2%
4/22 • 1 year
|
4.5%
1/22 • 1 year
|
|
Infections and infestations
Conjunctivitis
|
4.5%
1/22 • 1 year
|
22.7%
5/22 • 1 year
|
|
Infections and infestations
Erythema infectiosum
|
9.1%
2/22 • 1 year
|
4.5%
1/22 • 1 year
|
|
Infections and infestations
Gastroenteritis
|
18.2%
4/22 • 1 year
|
9.1%
2/22 • 1 year
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
9.1%
2/22 • 1 year
|
0.00%
0/22 • 1 year
|
|
Infections and infestations
Influenza
|
27.3%
6/22 • 1 year
|
27.3%
6/22 • 1 year
|
|
Infections and infestations
Nasopharyngitis
|
54.5%
12/22 • 1 year
|
50.0%
11/22 • 1 year
|
|
Infections and infestations
Otitis media
|
0.00%
0/22 • 1 year
|
9.1%
2/22 • 1 year
|
|
Infections and infestations
Pharyngitis
|
13.6%
3/22 • 1 year
|
18.2%
4/22 • 1 year
|
|
Infections and infestations
Rhinitis
|
9.1%
2/22 • 1 year
|
4.5%
1/22 • 1 year
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
4.5%
1/22 • 1 year
|
9.1%
2/22 • 1 year
|
|
Skin and subcutaneous tissue disorders
Eczema
|
9.1%
2/22 • 1 year
|
0.00%
0/22 • 1 year
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/22 • 1 year
|
13.6%
3/22 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place