Patient Perception of Treatment Burden in Weekly Versus D... | NCT03831880

ID	Type	Description	Link
2018-000918-38	EudraCT Number

Label	Type	Description	Intervention Names
Daily to Weekly	Other	Genotropin to somatrogon	Drug: Genotropin Drug: somatrogon
Weekly to Daily	Other	somatrogon to Genotropin	Drug: Genotropin Drug: somatrogon

Name	Type	Description	Arm Group Labels	Other Names
Genotropin	Drug	Genotropin (dose [mg] at time of enrollment) given subcutaneously once daily	Daily to Weekly Weekly to Daily

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Score Related to Overall Life Interference Assessed at Baseline, Using Dyad Clinical Outcomes Assessment 1 (DCOA 1) Questionnaire	Participants were assessed for their treatment burden using DCOA 1 questionnaire completed by participant/caregiver dyads. The participant life interference questionnaire component of the DCOA 1 had 7 questions (life interference [5 questions]: a measure of life interference [daily activities/social activities/leisure/night away from home/travel]; life interference-changes to life routine [1 question]: a measure of how often changes are made to life routine; and life interference-bother of growth hormone [GH] injections [1 question]: a measure of how often the growth hormone injections cause bother) and all questions used a 5-point scale: 1= never, 2= rarely, 3= sometimes, 4= often, 5= always. The overall life interference total score was sum of all 7 questions, scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant less life interference (better outcome).	Baseline
Total Score Related to Overall Life Interference Assessed at Week 12, Using DCOA 1 Questionnaire	Participants were assessed for their treatment burden using DCOA 1 questionnaire completed by participant/caregiver dyads. The participant life interference questionnaire component of the DCOA 1 had 7 questions (life interference [5 questions]: a measure of life interference [daily activities/social activities/leisure/night away from home/travel]; life interference-changes to life routine [1 question]: a measure of how often changes are made to life routine; and life interference-bother of growth hormone [GH] injections [1 question]: a measure of how often the growth hormone injections cause bother) and all questions used a 5-point scale: 1= never, 2= rarely, 3= sometimes, 4= often, 5= always. The overall life interference total score was sum of all 7 questions, scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant less life interference (better outcome).	Week 12
Total Score Related to Overall Life Interference Assessed at Week 24, Using DCOA 1 Questionnaire	Participants were assessed for their treatment burden using DCOA 1 questionnaire completed by participant/caregiver dyads. The participant life interference questionnaire component of the DCOA 1 had 7 questions (life interference [5 questions]: a measure of life interference [daily activities/social activities/leisure/night away from home/travel]; life interference-changes to life routine [1 question]: a measure of how often changes are made to life routine; and life interference-bother of growth hormone [GH] injections [1 question]: a measure of how often the growth hormone injections cause bother) and all questions used a 5-point scale: 1= never, 2= rarely, 3= sometimes, 4= often, 5= always. The overall life interference total score was sum of all 7 questions, scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant less life interference (better outcome).

Secondary Outcomes

Measure	Description	Time Frame
Total Score Related to Pen Ease of Use Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire	Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked 5 questions from Section I of the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool related to pen ease of use and used a 5-point scale: 1= very easy, 2= somewhat easy, 3= neither easy nor difficult, 4= somewhat difficult, 5= very difficult. The total score related to pen ease of use was sum of all 5 questions; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome.

Other Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Emergent Treatment Related AEs and SAEs	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Treatment-emergent AEs (TEAEs) were defined as events that occurred between first dose of study drug up to 35 days after last dose of study drug. Related TEAEs were those AEs who had relation to the study treatment and was judged by investigator.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged 3 years old and <18 years with either isolated GHD, or GH insufficiency.
Currently on treatment with either Genotropin Pen®, Genotropin GoQuick Pen®, HumatroPen® (United States of America [USA] only), or Omnitrope® Pen (USA only) ≥3 months and have been compliant on a stable dose (±10%) for at least 3 months prior to screening.
IGF I SDS < 2.
Subjects on hormonal replacement therapy for other hypothalamic pituitary axis (HPA) hormonal deficiencies and/or diabetes insipidus must be on an optimized and stable treatment regimen, as determined by the Investigator, for at least 3 months prior to screening.

Exclusion Criteria

History of leukemia, lymphoma, sarcoma or any other cancer.
History of radiation therapy or chemotherapy.
Children with psychosocial dwarfism.
Children born small for gestational age (SGA) - birth weight and/or birth length < 2 SDS for gestational age.
Other causes of short stature such as uncontrolled primary hypothyroidism and rickets.
Chromosomal abnormalities including Turner's syndrome, Laron syndrome, Noonan syndrome, Prader Willi syndrome, Russell Silver syndrome, short stature homeobox (SHOX) mutations/deletions or skeletal dysplasias.
Treatment with regularly scheduled daily or weekly injectable medications other than Genotropin® Pen, Genotropin GoQuick®, HumatroPen® (USA only), or Omnitrope® Pen (USA only).
Diabetes Mellitus.
Current treatment with Genotropin MiniQuick.
History of any exposure to a long acting hGH preparation.
Known or suspected human immunodeficiency virus (HIV) positive patient, or patient with advanced diseases such as acquired immunodeficiency syndrome (AIDS) or tuberculosis.
Drug, substance, or alcohol abuse.
Known hypersensitivity to the components of the medication.
Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
Participation in other studies involving investigational drug(s) within 30 days prior to study entry and/or during study participation.
Patient and/or the parent/legal guardian are likely to be non-compliant with respect to study conduct.
Subject and/or the parent/legal guardian are unable to understand written and/or verbal instructions on the proper use of growth hormone injection devices.
Children with closed epiphyses (this determination can be based on available existing clinical data).

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Center of Excellence in Diabetes and Endocrinology		Sacramento	California	95821	United States
Children's Hospital Colorado

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 26, 2019	Aug 20, 2021

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

Total Score Related to Overall Life Interference Assessed at Baseline, Using Dyad Clinical Outcomes Assessment 1 (DCOA 1) Questionnaire

Participants were assessed for their treatment burden using DCOA 1 questionnaire completed by participant/caregiver dyads. The participant life interference questionnaire component of the DCOA 1 had 7 questions (life interference [5 questions]: a measure of life interference [daily activities/social activities/leisure/night away from home/travel]; life interference-changes to life routine [1 question]: a measure of how often changes are made to life routine; and life interference-bother of growth hormone [GH] injections [1 question]: a measure of how often the growth hormone injections cause bother) and all questions used a 5-point scale: 1= never, 2= rarely, 3= sometimes, 4= often, 5= always. The overall life interference total score was sum of all 7 questions, scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant less life interference (better outcome).

Posted

Mean

Standard Deviation

units on a scale

Baseline

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.
OG001	Weekly Somatrogon Then Daily Genotropin	Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.

Units	Counts
Participants	OG00042 OG00140

Title

Denominators

Categories

Title	Measurements
	OG00029.5± 18.0 OG00127.1± 19.8

Primary

Total Score Related to Overall Life Interference Assessed at Week 12, Using DCOA 1 Questionnaire

Posted

Mean

Standard Deviation

units on a scale

Week 12

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.

Primary

Total Score Related to Overall Life Interference Assessed at Week 24, Using DCOA 1 Questionnaire

Posted

Mean

Standard Deviation

units on a scale

Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.

Primary

Total Score Related to Overall Life Interference by Treatment in Overall Study, Using DCOA 1 Questionnaire

Posted

Mean

95% Confidence Interval

units on a scale

Baseline up to Week 24

ID	Title	Description
OG000	Genotropin	Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).
OG001	Somatrogon

Secondary

Total Score Related to Pen Ease of Use Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire

Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked 5 questions from Section I of the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool related to pen ease of use and used a 5-point scale: 1= very easy, 2= somewhat easy, 3= neither easy nor difficult, 4= somewhat difficult, 5= very difficult. The total score related to pen ease of use was sum of all 5 questions; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome.

The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here 'number analyzed' signifies participants evaluable for each specified time points.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12, Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.

Secondary

Total Score Related to Pen Ease of Use by Treatment in Overall Study, Using DCOA 1 Questionnaire

Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked 5 questions from Section I of the IPAQ PRO tool related to pen ease of use and used a 5-point scale: 1= very easy, 2= somewhat easy, 3= neither easy nor difficult, 4= somewhat difficult, 5= very difficult. The total score related to pen ease of use was sum of all 5 questions; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome.

Posted

Mean

95% Confidence Interval

units on a scale

Baseline up to Week 24

ID	Title	Description
OG000	Genotropin	Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).
OG001	Somatrogon	Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).

Secondary

Total Score Related to Ease of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire

Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to ease of injection schedule and used a 5-point scale: 1= very easy, 2= somewhat easy, 3= neither easy nor difficult, 4= somewhat difficult, 5= very difficult. The total score related to ease of the injection schedule ranged from 1 to 5; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12, Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.
OG001

Secondary

Total Score Related to Ease of the Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire

Posted

Mean

95% Confidence Interval

units on a scale

Baseline up to Week 24

ID	Title	Description
OG000	Genotropin	Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).
OG001	Somatrogon	Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).

Secondary

Total Score Related to Convenience of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire

Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to ease of injection schedule and used a 7-point scale: 1=extremely convenient to 7=extremely inconvenient. The total score related to convenience of injection schedule ranged from 1 to 7; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12, Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.
OG001

Secondary

Total Score Related to Convenience of the Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire

Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to ease of injection schedule and used a 7-point scale: 1=extremely convenient to 7=extremely inconvenient. The total score related to convenience of injection schedule ranged from 1 to 7; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome.

Posted

Mean

95% Confidence Interval

units on a scale

Baseline up to Week 24

ID	Title	Description
OG000	Genotropin	Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).
OG001	Somatrogon	Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).

Secondary

Total Score Related to Satisfaction With Overall Treatment Experience Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire

Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to participant satisfaction with treatment and used a 5-point scale: 1=very satisfied to 5=very dissatisfied. The total score related to satisfaction with overall treatment ranged from 1 to 5; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12, Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.
OG001

Secondary

Total Score Related to Satisfaction With Overall Treatment Experience by Treatment in Overall Study, Using DCOA 1 Questionnaire

Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to participant satisfaction with treatment and used a 5-point scale: 1=very satisfied to 5=very dissatisfied. The total score related to satisfaction with overall treatment ranged from 1 to 5; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome.

Posted

Mean

95% Confidence Interval

units on a scale

Baseline up to Week 24

ID	Title	Description
OG000	Genotropin	Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).
OG001	Somatrogon	Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).

Secondary

Total Scores Related to Willingness to Continue Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire

Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to participant willingness to continue treatment and used a 5-point scale: 1=extremely willing to 5=not at all willing. The total score related to willingness to continue injection schedule ranged from 1 to 5; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12, Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.
OG001

Secondary

Total Scores Related to Willingness to Continue Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire

Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to participant willingness to continue treatment and used a 5-point scale: 1=extremely willing to 5=not at all willing. The total score related to willingness to continue injection schedule ranged from 1 to 5; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome.

Posted

Mean

95% Confidence Interval

units on a scale

Baseline up to Week 24

ID	Title	Description
OG000	Genotropin	Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).
OG001	Somatrogon	Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).

Secondary

Total Scores Related to Injection Signs and Symptoms for Participants Aged 8 Years and Above Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire

Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participants (8-17 years old). Participants were asked 4 questions from Section I of the IPAQ PRO tool related to participant's injection signs and symptoms and used a 11-point scale: 0=no pain to 10=worst possible pain; 0=no stinging to 10=worst possible stinging; 0=no bruising to 10=worst possible bruising; and 0=no bleeding to 10=worst possible bleeding, respectively. The total score was sum of all questions; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score for injection signs and symptoms meant a better outcome.

The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Here 'number analyzed' signifies participants aged 8 years or above and evaluable for each specified time points.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12, Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.

Secondary

Total Scores Related to Injection Signs and Symptoms for Participants Aged 8 Years and Above by Treatment in Overall Study, Using DCOA 1 Questionnaire

The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here "Overall number of participants analyzed" signifies participants aged 8 years or above and evaluable for this outcome measure.

Posted

Mean

95% Confidence Interval

units on a scale

Baseline up to Week 24

ID	Title	Description
OG000	Genotropin	Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).
OG001	Somatrogon	Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).

Secondary

Total Scores Related to Assessment of Signs, Completed by Caregiver for Children Aged <8 Years Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire

Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by caregiver for children under 8 years. Participants were asked 2 questions from Section I of the IPAQ PRO tool related to participant's assessment of signs and used a 11-point scale: 0=no bruising to 10=worst possible bruising and 0=no bleeding to 10=worst possible bleeding, respectively. The total score was sum of all questions; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score for assessment of signs meant a better outcome.

The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Here 'number analyzed' signifies participants aged 8 years or below and evaluable for each specified time points.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12, Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.

Secondary

Total Scores Related to Assessment of Signs, Completed by Caregiver for Children Aged <8 Years by Treatment in Overall Study, Using DCOA 1 Questionnaire

The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here "Overall number of participants analyzed" signifies participants aged 8 years or below and evaluable for this outcome measure.

Posted

Mean

95% Confidence Interval

units on a scale

Baseline up to Week 24

ID	Title	Description
OG000	Genotropin	Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).
OG001	Somatrogon	Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).

Secondary

Total Scores Related to Caregiver Life Interference, Including Family Life Interference Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire

Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by caregiver. Participants were asked 13 questions from Section I of the IPAQ PRO tool related to caregiver life interference and used a 5-point scale: 1= never to 5= always. The total score ranged was sum of scores from all questions; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score for caregiver and family life interference meant less life interference (a better outcome).

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12, Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.
OG001

Secondary

Total Scores Related to Caregiver Life Interference, Including Family Life Interference by Treatment in Overall Study, Using DCOA 1 Questionnaire

Posted

Mean

95% Confidence Interval

units on a scale

Baseline up to Week 24

ID	Title	Description
OG000	Genotropin	Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).
OG001	Somatrogon	Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).

Secondary

Total Scores Related to Missed Injections Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire

Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to number of missed injections (daily or weekly administration) during past 4 weeks. The total scores ranged from 0 to 31 for daily administration (Genotropin) and from 0 to 5 for weekly administration (Somatrogon). All scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score for missed injections meant a better outcome.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12, Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.
OG001

Secondary

Total Scores Related to Missed Injections by Treatment in Overall Study, Using DCOA 1 Questionnaire

Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to number of missed injections (daily or weekly administration) during past 4 weeks. The total scores ranged from 0 to 31 for daily administration (Genotropin) and from 0 to 5 for weekly administration (Somatrogon). All scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score for missed injections meant a better outcome.

Posted

Mean

95% Confidence Interval

units on a scale

Baseline up to Week 24

ID	Title	Description
OG000	Genotropin	Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).
OG001	Somatrogon	Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).

Secondary

Number of Participants as Per Responses to Choice of Injection Pen Assessed at Week 24, Using DCOA 2 Questionnaire

Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregivers responded to question from Section II of the IPAQ PRO tool "If you were given the choice between the daily growth hormone injection pen and the weekly growth hormone injection pen, which pen would you choose?" Response was: 1) the daily injection pen (Genotropin) or 2) the weekly injection pen (Somatrogon).

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.
OG001	Weekly Somatrogon Then Daily Genotropin

Secondary

Number of Participants as Per Responses to Preferred Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire

Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregivers responded to question from Section II of the IPAQ PRO tool "Which growth hormone injection schedule do you prefer overall?" by choosing from any 1 option from: 1) prefer the weekly injection schedule (Somatrogon); 2) prefer the daily injection schedule (Genotropin); 3) no preference.

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.
OG001	Weekly Somatrogon Then Daily Genotropin

Secondary

Number of Participants as Per Responses to Convenience of the Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire

Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregivers responded to question from Section II of the IPAQ PRO tool "Which growth hormone injection schedule was more convenient overall?" by choosing from any 1 option from: 1) weekly injection schedule was more convenient (Somatrogon); 2) daily injection schedule was more convenient (Genotropin); 3) no difference.

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.
OG001	Weekly Somatrogon Then Daily Genotropin

Secondary

Number of Participants as Per Responses to Ease of Following Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire

Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregivers responded to question from Section II of the IPAQ PRO tool "Which growth hormone injection schedule was easier to follow overall?" by choosing from any 1 option from: 1) easier to follow weekly injection schedule (Somatrogon); 2) easier to follow daily injection schedule (Genotropin); 3) no difference.

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.
OG001	Weekly Somatrogon Then Daily Genotropin

Secondary

Number of Participants as Per Responses to Pen Ease of Use Assessed at Week 24, Using DCOA 2 Questionnaire

Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregiver were asked a question "Which pen was easier to use?" from Section II of the IPAQ PRO tool. Question had 4 parts: preparing the injection pen (Part I), setting the dose (Part II), injecting the medicine (Part III) and storing the pen (Part IV). Participants/caregiver expressed their preference by choosing from any 1 option for each activity from: 1) weekly pen easier to use (Somatrogon); 2) daily pen easier to use (Genotropin); 3) no difference.

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.

Secondary

Number of Participants as Per Responses to Participant Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire

Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregiver were asked a question "Which injection schedule interfered less?" from Section II of the IPAQ PRO tool related to participant life interference. Participants were assessed for 5 activities: daily activities (Activity 1), social activities (Activity 2), recreation/leisure activities (Activity 3), spending night away from home (Activity 4) and travel (Activity 5). The participants expressed their preference by choosing from any 1 option for each activity from: 1) weekly injection schedule interfered less (Somatrogon); 2) daily injection schedule interfered less (Genotropin); 3) no difference.

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.

Secondary

Number of Participants as Per Responses to Caregiver Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire

Caregivers of participants were asked a question "Which injection schedule interfered less?" from Section II of the IPAQ PRO tool related to caregiver life interference and were assessed for 5 activities: daily activities (Activity 1), social activities (Activity 2), recreation/leisure activities (Activity 3), spending night away from home (Activity 4) and travel (Activity 5). Preference was expressed by choosing from any 1 option for each activity from: 1) weekly injection schedule interfered less (Somatrogon); 2) daily injection schedule interfered less (Genotropin); 3) no difference. The caregivers responded for the participants, and in actual they respond to the number of participants only but per caregiver responses.

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.

Secondary

Number of Participants as Per Responses to Family Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire

Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/ caregiver were asked a question "Which injection schedule interfered less?" from Section II of the IPAQ PRO tool related to family life interference and assessed for 5 activities: daily activities (Activity 1), social activities (Activity 2), recreation/leisure activities (Activity 3), spending night away from home (Activity 4) and travel (Activity 5). Preference was expressed by choosing from any 1 option for each activity from: 1) weekly injection schedule interfered less (Somatrogon); 2) daily injection schedule interfered less (Genotropin); 3) no difference.

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.

Secondary

Number of Participants as Per Response to Benefit Relating to the Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire

Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregiver were asked a question "How beneficial was to take injections less often?" from Section II of the IPAQ PRO tool pertaining to benefit relating to the Injection schedule and used a 5-point scale: 1= extremely beneficial, 2= very beneficial, 3= moderately beneficial, 4= slightly beneficial and 5= not at all beneficial. Lower score of benefit relating to injection schedule meant a better outcome.

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.
OG001

Secondary

Number of Participants as Per Responses to Intention to Comply Assessed at Week 24, Using DCOA 2 Questionnaire

Participants/caregiver dyads were asked 4 questions "Which schedule would be better able to follow?" (Question 1), "Which schedule would be more likely to follow for a longer time?" (Question 2), "Which schedule would be better able to follow for a longer time?" (Question 3) and "Which schedule would be more likely to follow?" (Question 4) from Section II of the IPAQ PRO tool related to participant intention to comply with treatment. Options for each question were: 1) weekly injection (Somatrogon) 2) daily injection (Genotropin), or 3) no difference.

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.
OG001

Secondary

Patient Global Impression Severity-Impact on Daily Activities (PGIS-IDA) Score Assessed at Baseline, Week 12 and Week 24

The PGIS-IDA rated the severity of the impact on daily activities due to the treatment administration during the past 4 weeks on a 7-point scale (1= not present to 7= extremely severe). Scores were transformed from raw scores to a 0 to 100 scale. Lower scores meant less impact on daily activities (better outcome).

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12, Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.
OG001	Weekly Somatrogon Then Daily Genotropin	Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.

Secondary

Patient Global Impression Severity-Impact on Daily Activities (PGIS-IDA) Score by Treatment in Overall Study

Posted

Mean

95% Confidence Interval

units on a scale

Baseline up to Week 24

ID	Title	Description
OG000	Genotropin	Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).
OG001	Somatrogon	Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).

Units	Counts
Participants

Other Pre-specified

Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Emergent Treatment Related AEs and SAEs

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Treatment-emergent AEs (TEAEs) were defined as events that occurred between first dose of study drug up to 35 days after last dose of study drug. Related TEAEs were those AEs who had relation to the study treatment and was judged by investigator.

The safety analysis set included all participants who received at least 1 dose of study intervention. The participants were analyzed according to the intervention they actually received.

Posted

Count of Participants

Participants

Baseline up to 35 days after last dose of study drug (up to 29 Weeks)

ID	Title	Description
OG000	Genotropin	Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).
OG001	Somatrogon	Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).

Other Pre-specified

Number of Participants With Adverse Events According to Severity

AEs were assessed and categorized according to the severity as mild (did not interfered with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function).

The safety analysis set included all participants who received at least 1 dose of study intervention. The participants were analyzed according to the intervention they actually received.

Posted

Count of Participants

Participants

Baseline up to 35 days after last dose of study drug (up to 29 Weeks)

ID	Title	Description
OG000	Genotropin	Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).
OG001	Somatrogon	Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).

Units	Counts
Participants

Other Pre-specified

Number of Participants With Discontinuation Due to Adverse Events (AEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The discontinuations due to adverse events was defined for participants and reported in this outcome measure.

The safety analysis set included all participants who received at least 1 dose of study intervention. The participants were analyzed according to the intervention they actually received.

Posted

Count of Participants

Participants

Baseline up to 35 days after last dose of study drug (up to 29 Weeks)

ID	Title	Description
OG000	Genotropin	Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).
OG001	Somatrogon	Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).

Units	Counts
Participants

Other Pre-specified

Number of Participants With Laboratory Abnormalities

The laboratory abnormality parameters included Hematology: erythrocyte (Er.) mean corpuscular volume, Er. mean corpuscular hemoglobin:<0.9*lower limit normal (LLN), leukocytes:<0.6*LLN, lymphocytes:<0.8*LLN, neutrophils:<0.8*LLN, greater than (>) 1.2*upper limit normal (ULN), eosinophils, monocytes:>1.2*ULN. Clinical chemistry: bilirubin, direct bilirubin, indirect bilirubin:>1.5*ULN, gamma glutamyl transferase:>3.0*ULN, albumin:>1.2*ULN, blood urea nitrogen:>1.3*ULN, urate:>1.2*ULN, high-density lipoprotein (HDL) cholesterol:<0.8*LLN, potassium, magnesium:>1.1*ULN, phosphate:>1.2*ULN, bicarbonate:<0.9*LLN, creatine kinase:>2.0*ULN. Urinalysis: specific gravity:>1.030, ketones, urine protein, urine hemoglobin, nitrite, leukocyte esterase:>=1.

Posted

Count of Participants

Participants

Week 1 to Week 12, Week 13 to Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.

Other Pre-specified

Number of Participants With Positive Anti-Recombinant Human Growth Hormone (rhGH) Antibodies and Neutralizing Antibodies (NAb)

Blood samples were collected for determination of rhGH and NAb. The participants who tested positive for antibodies were reported.

The safety analysis set included all participants who received at least 1 dose of study intervention. The participants were analyzed according to the intervention they actually received.

Posted

Count of Participants

Participants

Baseline, Week 12, Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.
OG001	Weekly Somatrogon Then Daily Genotropin	Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.

Other Pre-specified

Number of Participants With Positive Anti-Somatrogon Antibodies and Neutralizing Antibodies (NAb)

Blood samples were collected for determination of anti-somatrogon antibodies and NAb. The participants who tested positive for antibodies were reported.

The safety analysis set included all participants who received at least 1 dose of study intervention. The participants were analyzed according to the intervention they actually received. "0" in number analyzed field denotes that participants who followed the 'Genotropin then Somatrogon' sequence were not tested for anti-somatrogon ADA at Week 12 and participants who followed the 'Somatrogon then Genotropin' sequence were not tested for anti-somatrogon ADA at Week 24.

Posted

Count of Participants

Participants

Baseline, Week 12, Week 24

ID	Title	Description
OG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.
OG001	Weekly Somatrogon Then Daily Genotropin

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ear pain	Ear and labyrinth disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Hyperacusis	Ear and labyrinth disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Adrenocortical insufficiency acute	Endocrine disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Eye pruritus	Eye disorders	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected87 at risk
Vision blurred	Eye disorders	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected87 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Nausea	Gastrointestinal disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Tongue ulceration	Gastrointestinal disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Vomiting	Gastrointestinal disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0012 affected87 at risk
Administration site oedema	General disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Administration site pain	General disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0012 affected87 at risk
Application site pruritus	General disorders	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected87 at risk
Fat tissue increased	General disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Influenza like illness	General disorders	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0011 affected87 at risk
Injection site bruising	General disorders	MedDRA v23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0011 affected87 at risk
Injection site erythema	General disorders	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0011 affected87 at risk
Injection site haematoma	General disorders	MedDRA v23.0	Non-systematic Assessment	EG0008 affected86 at risk EG0014 affected87 at risk
Injection site haemorrhage	General disorders	MedDRA v23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected87 at risk
Injection site pain	General disorders	MedDRA v23.0	Non-systematic Assessment	EG00011 affected86 at risk EG00113 affected87 at risk
Injection site reaction	General disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Injection site swelling	General disorders	MedDRA v23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0012 affected87 at risk
Pyrexia	General disorders	MedDRA v23.0	Non-systematic Assessment	EG0004 affected86 at risk EG0012 affected87 at risk
Hypersensitivity	Immune system disorders	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected87 at risk
Conjunctivitis	Infections and infestations	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Conjunctivitis viral	Infections and infestations	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected87 at risk
Ear infection	Infections and infestations	MedDRA v23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0013 affected87 at risk
Gastroenteritis	Infections and infestations	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected87 at risk
Impetigo	Infections and infestations	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected87 at risk
Influenza	Infections and infestations	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Laryngitis	Infections and infestations	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected87 at risk
Nasopharyngitis	Infections and infestations	MedDRA v23.0	Non-systematic Assessment	EG0005 affected86 at risk EG0016 affected87 at risk
Otitis media	Infections and infestations	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected87 at risk
Pharyngitis	Infections and infestations	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected87 at risk
Pneumonia	Infections and infestations	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected87 at risk
Respiratory tract infection	Infections and infestations	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0011 affected87 at risk
Rhinitis	Infections and infestations	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Tonsillitis	Infections and infestations	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected87 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0014 affected87 at risk
Urinary tract infection	Infections and infestations	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected87 at risk
Viral infection	Infections and infestations	MedDRA v23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0011 affected87 at risk
Viral rash	Infections and infestations	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected87 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA v23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected87 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Body temperature increased	Investigations	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0013 affected87 at risk
Insulin-like growth factor increased	Investigations	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0013 affected87 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0012 affected87 at risk
Headache	Nervous system disorders	MedDRA v23.0	Non-systematic Assessment	EG0005 affected86 at risk EG0016 affected87 at risk
Lethargy	Nervous system disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Migraine	Nervous system disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Paraesthesia	Nervous system disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Emotional distress	Psychiatric disorders	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0011 affected87 at risk
Insomnia	Psychiatric disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Irritability	Psychiatric disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0014 affected87 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0012 affected87 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected87 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0011 affected87 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk
Excessive exercise	Social circumstances	MedDRA v23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected87 at risk

ID	Term
D004392	Dwarfism
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D001849	Bone Diseases, Endocrine
D007018	Hypopituitarism
D010900	Pituitary Diseases
D007027	Hypothalamic Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D004700	Endocrine System Diseases

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

ID	Title	Description
BG000	Daily Genotropin Then Weekly Somatrogon	Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.
BG001	Weekly Somatrogon Then Daily Genotropin	Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Genotropin	Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).	0	86	0	86	38	86
EG001	Somatrogon	Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).	0	87	0	87	47	87