A Research Study in Children With a Low Level of Hormone... | NCT03811535

NCT03811535

ID	Type	Description
U1111-1207-9691	Other Identifier	World Health Organization (WHO)
2018-000231-27	Other Identifier	European Medicines Agency (EudraCT)
JapicCTI-194773	Registry Identifier	JAPIC (Japan)

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Somapacitan weekly	Experimental	Participants will receive somapacitan weekly for 52 weeks (main trial period). Participants completing the main trial period in both the treatment arms ('Somapacitan weekly' and 'Norditropin® daily') will receive somapacitan weekly for 3 years (extension trial period).	Drug: Somapacitan
Norditropin® daily	Active Comparator	Participants will receive Norditropin® daily for 52 weeks (main trial period).	Drug: Norditropin®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Somapacitan	Drug	Somapacitan will be administered subcutaneously (s.c.; under the skin) once weekly by PDS290 pen-injector. Somapacitan can be injected any time during the once weekly dosing day. The dose will be calculated based on the subject's current body weight.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Height Velocity: In-trial Observation Period	Height velocity (HV) was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.	From baseline (week 0) to visit 7 (week 52)
Height Velocity: On-treatment Observation Period	Height velocity was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'on-treatment' observation period. On-treatment observation period: from first administration and up until last trial contact, visit 7 or 14 days after last administration, whichever comes first.	From baseline (week 0) to visit 7 (week 52)

Secondary Outcomes

Measure	Description	Time Frame
Change in Bone Age	Change from baseline (week -2) in bone age at week 52 is presented. X-ray images of left hand and wrist for bone age assessment according to the Greulich and Pyle atlas were taken. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.	Baseline (week -2), week 52

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Prepubertal children: a) Boys: Age more than or equal to 2 years and 26 weeks and less than 11.0 years at screening. Testis volume less than 4 ml. b) Girls: Age more than or equal to 2 years and 26 weeks and less than 10.0 years at screening. Tanner stage 1 for breast development (no palpable glandular breast tissue)
Confirmed diagnosis of growth hormone deficiency determined by two different growth hormone stimulation tests performed within 12 months prior to randomisation, defined as a peak growth hormone level of less than or equal to 10.0 ng/ml using the World Health Organisation (WHO) International Somatropin 98/574 standard
Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and gender at screening according to the standards of Center for Disease Control and Prevention
Impaired height velocity, defined as annualised height velocity below the 25th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening
Insulin-like Growth Factor-I (IGF-I) less than -1.0 SDS at screening, compared to age and gender normalized range measured at central laboratory
No prior exposure to growth hormone therapy or IGF-I treatment

Exclusion Criteria:

Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements
Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening
Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 μg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening
Diagnosis of attention deficit hyperactivity disorder
Concomitant administration of other treatments that may have an effect on growth, e.g. but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder
Prior history or presence of malignancy including intracranial tumours

Name	Affiliation	Role
Clinical Transparency (dept. 2834)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Univ of AL at Birmingham_BRM		Birmingham	Alabama	35233	United States
Children's Hospital Los Angeles - Endocrinology

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40400262	Derived	Miller BS, Blair JC, Rasmussen MH, Frystyk J, Lemminger AK, Maniatis A, Mori J, Bottcher V, Kim HS, Polak M, Horikawa R. Efficacy, safety, and insulin-like growth factor I of weekly somapacitan in children with growth hormone deficiency: 3-year results from REAL4. Eur J Endocrinol. 2025 Apr 30;192(5):651-661. doi: 10.1093/ejendo/lvaf096.
38368603

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Norditropin	Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 22, 2021

Arm/Group Information

ID	Title	Description
BG000	Norditropin	Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
BG001	Somapacitan	Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0006.43± 2.42 BG0016.38± 2.23 BG0026.40± 2.29

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00018 BG00133 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0014 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Race

Title	Measurements
White	BG00036 BG00178 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Height Velocity: In-trial Observation Period

Height velocity (HV) was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Full analysis set included all randomized participants.

Posted

Mean

Standard Deviation

centimeters per year (cm/year)

From baseline (week 0) to visit 7 (week 52)

ID	Title	Description
OG000	Norditropin	Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
OG001	Somapacitan	Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).

Units	Counts
Participants	OG00068 OG001132

Title

Denominators

Categories

Title	Measurements
	OG00011.8± 2.9 OG00111.2± 2.5

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Height velocity at week 52 was analyzed using an analysis of covariance model with treatment, gender, age group, region, growth hormone (GH) peak group and gender by age group by region interaction term as factors, and baseline height as covariate.	ANCOVA				Treatment difference	-0.5			2-Sided	95	-1.1	0.2					Non-Inferiority	The pre-specified non-inferiority margin was -1.8 cm/year.

Primary

Height Velocity: On-treatment Observation Period

Height velocity was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'on-treatment' observation period. On-treatment observation period: from first administration and up until last trial contact, visit 7 or 14 days after last administration, whichever comes first.

Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data.

Posted

Mean

Standard Deviation

cm/year

From baseline (week 0) to visit 7 (week 52)

ID	Title	Description
OG000	Norditropin	Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
OG001	Somapacitan	Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).

Secondary

Change in Bone Age

Change from baseline (week -2) in bone age at week 52 is presented. X-ray images of left hand and wrist for bone age assessment according to the Greulich and Pyle atlas were taken. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data.

Posted

Mean

Standard Deviation

Years

Baseline (week -2), week 52

ID	Title	Description
OG000	Norditropin	Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
OG001	Somapacitan	Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).

Units	Counts

Secondary

Change in Height Standard Deviation Score (HSDS)

Change from baseline (week 0) in HSDS at week 52 is presented. HSDS was derived using Centre for Disease Control and Prevention (CDC) standards. The range for HSDS was -10 to +10. Negative scores indicated a height below the mean height for a child with the same age and gender, whereas positive scores indicated a height above the mean height for a child with the same age and gender. Positive value in change from baseline in HSDS indicated that HSDS was better than baseline HSDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Full analysis set included all randomized participants.

Posted

Mean

Standard Deviation

Score on a scale

Baseline (week 0), week 52

ID	Title	Description
OG000	Norditropin	Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
OG001	Somapacitan	Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).

Secondary

Change in Height Velocity Standard Deviation Score (HV SDS)

Change from baseline (week 0) in HV SDS at week 52 is presented. HV SDS was calculated using the formula: HV SDS = (height velocity - mean)/standard deviation (SD), where height velocity was the height velocity variable measured, mean and SD of height velocity by gender and age for the reference population. The range for HV SDS was -10 to +10. Negative scores indicated a height velocity below the mean height velocity for a child with the same age and gender, whereas positive scores indicated a height velocity above the mean height velocity for a child with the same age and gender. Positive value in change from baseline in HV SDS indicated that HV SDS was better than baseline HV SDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Full analysis set included all randomized participants.

Posted

Mean

Standard Deviation

Score on a scale

Baseline (week 0), week 52

ID	Title	Description
OG000	Norditropin	Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
OG001	Somapacitan	Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).

Secondary

Change in Fasting Plasma Glucose (FPG) at Week 52

Change from baseline (week -2) in FPG at week 52 is presented.

Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = participants with available data.

Posted

Mean

Standard Deviation

Millimoles per liter (mmol/L)

Baseline (week -2), week 52

ID	Title	Description
OG000	Norditropin	Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
OG001	Somapacitan	Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).

Units	Counts
Participants

Secondary

Change in FPG at Week 104

Not Posted

Sep 2026

Baseline (week -2), week 104

Participants

Secondary

Change in FPG at Week 156

Not Posted

Sep 2026

Baseline (week -2), week 156

Participants

Secondary

Change in FPG at Week 208

Not Posted

Sep 2026

Baseline (week -2), week 208

Participants

Secondary

Change in Homeostatic Model Assessment Steady State Beta Cell Function (HOMA-B) at Week 52

Change from baseline (week -2) in HOMA-B at week 52 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 * fasting insulin (picomoles per liter [pmol/L]) * 1/6(microunit per milliliter [µU/mL]))/ FPG(mmol/L)-3.5). Negative change from baseline in HOMA-B indicated a worse outcome.

Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = participants with available data.

Posted

Mean

Standard Deviation

Percentage of HOMA-B

Baseline (week -2), week 52

ID	Title	Description
OG000	Norditropin	Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
OG001	Somapacitan	Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).

Secondary

Change in HOMA-B at Week 104

Not Posted

Sep 2026

Baseline (week -2), week 104

Participants

Secondary

Change in HOMA-B at Week 156

Not Posted

Sep 2026

Baseline (week -2), week 156

Participants

Secondary

Change in HOMA-B at Week 208

Not Posted

Sep 2026

Baseline (week -2), week 208

Participants

Secondary

Change in Homeostatic Model Assessment Insulin Resistance (HOMA-IR) at Week 52

Change from baseline (week -2) in HOMA-IR at week 52 is presented. HOMA-IR is an evaluation of the insulin resistance and was calculated as HOMA-IR = fasting insulin (pmol/L) * 1/6(µU/mL) * FPG(mmol/L) / 22.5. Positive change from baseline in HOMA-IR indicated a worse outcome.

Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = participants with available data.

Posted

Mean

Standard Deviation

Percentage of HOMA-IR

Baseline (week -2), week 52

ID	Title	Description
OG000	Norditropin	Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
OG001	Somapacitan	Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).

Secondary

Change in HOMA-IR at Week 104

Not Posted

Sep 2026

Baseline (week -2), week 104

Participants

Secondary

Change in HOMA-IR at Week 156

Not Posted

Sep 2026

Baseline (week -2), week 156

Participants

Secondary

Change in HOMA-IR at Week 208

Not Posted

Sep 2026

Baseline (week -2), week 208

Participants

Secondary

Change in Glycated Haemoglobin (HbA1c) at Week 52

Change from baseline (week -2) in HbA1c at week 52 is presented.

Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = participants with available data.

Posted

Mean

Standard Deviation

Percentage of HbA1c

Baseline (week -2), week 52

ID	Title	Description
OG000	Norditropin	Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
OG001	Somapacitan	Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).

Units	Counts
Participants

Secondary

Change in HbA1c at Week 104

Not Posted

Sep 2026

Baseline (week -2), week 104

Participants

Secondary

Change in HbA1c at Week 156

Not Posted

Sep 2026

Baseline (week -2), week 156

Participants

Secondary

Change in HbA1c at Week 208

Not Posted

Sep 2026

Baseline (week -2), week 208

Participants

Secondary

Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS) at Week 52

Change from baseline (week 0) in IGF-I SDS at week 52 is presented. The range for IGF-I SDS was from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender. For participants with low IGF-I SDS at baseline, a positive change from baseline in IGF-I SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data.

Posted

Mean

Standard Deviation

Score on a scale

Baseline (week 0), week 52

ID	Title	Description
OG000	Norditropin	Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
OG001	Somapacitan	Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).

Secondary

Change in IGF-I SDS at Week 104

Not Posted

Sep 2026

Baseline (week 0), week 104

Participants

Secondary

Change in IGF-I SDS at Week 156

Not Posted

Sep 2026

Baseline (week 0), week 156

Participants

Secondary

Change in IGF-I SDS at Week 208

Not Posted

Sep 2026

Baseline (week 0), week 208

Participants

Secondary

Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Standard Deviation Score (SDS) at Week 52

Change from baseline (week 0) in IGFBP-3 SDS at week 52 is presented. The range for IGFBP-3 SDS was from -10 to +10. Negative scores indicated a IGFBP-3 below the mean IGFBP-3 for a child with the same age and gender, whereas positive scores indicated a IGFBP-3 above the mean IGFBP-3 for a child with the same age and gender. For participants with low IGFBP-3 SDS at baseline, a positive change from baseline in IGFBP-3 SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data.

Posted

Mean

Standard Deviation

Score on a scale

Baseline (week 0), week 52

ID	Title	Description
OG000	Norditropin	Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
OG001	Somapacitan	Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).

Secondary

Change in IGFBP-3 SDS at Week 104

Not Posted

Sep 2026

Baseline (week 0), week 104

Participants

Secondary

Change in IGFBP-3 SDS at Week 156

Not Posted

Sep 2026

Baseline (week 0), week 156

Participants

Secondary

Change in IGFBP-3 SDS at Week 208

Not Posted

Sep 2026

Baseline (week 0), week 208

Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Norditropin	Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).	0	68	2	68	22	68
EG001	Somapacitan	Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).	0	132	6	132	46	132

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Adenoidal hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected132 at risk
Adrenocortical insufficiency acute	Endocrine disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected68 at risk EG0010 events0 affected132 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected132 at risk
COVID-19	Infections and infestations	MedDRA 24	Systematic Assessment	EG0001 events1 affected68 at risk EG0010 events0 affected132 at risk
Cryptorchism	Congenital, familial and genetic disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected132 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected132 at risk
Gastroenteritis	Infections and infestations	MedDRA 24	Systematic Assessment	EG0001 events1 affected68 at risk EG0010 events0 affected132 at risk
Headache	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected132 at risk
Otitis media	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected132 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected132 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected132 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bronchitis	Infections and infestations	MedDRA 24	Systematic Assessment	EG0005 events5 affected68 at risk EG0016 events4 affected132 at risk
Headache	Nervous system disorders	MedDRA 24	Systematic Assessment	EG00011 events6 affected68 at risk EG00122 events16 affected132 at risk
Nasopharyngitis	Infections and infestations	MedDRA 24	Systematic Assessment	EG00013 events7 affected68 at risk EG00122 events15 affected132 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24	Systematic Assessment	EG0004 events2 affected68 at risk EG00117 events12 affected132 at risk
Pyrexia	General disorders	MedDRA 24	Systematic Assessment	EG00012 events7 affected68 at risk EG00114 events10 affected132 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0006 events4 affected68 at risk EG00110 events6 affected132 at risk

ID	Term
D013006	Growth Hormone
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins