Trial Outcomes & Findings for Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD (NCT NCT03831880)

Last Updated: 2021-10-14

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

87 participants

Primary outcome timeframe

Baseline

Results posted on

2021-10-14

Participant Flow

107 participants were screened for study eligibility. 87 Participants, aged 3 to less than 18 years with growth hormone deficiency (GHD) on stable treatment with somatropin, were deemed eligible for enrollment and randomized to receive treatment.

Participant milestones

Participant milestones
Measure	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.	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.
Period 1 (12 Weeks) STARTED	43	44
Period 1 (12 Weeks) COMPLETED	43	43
Period 1 (12 Weeks) NOT COMPLETED	0	1
Period 2 (12 Weeks) STARTED	43	43
Period 2 (12 Weeks) COMPLETED	43	42
Period 2 (12 Weeks) NOT COMPLETED	0	1
Follow-up (5 Weeks) STARTED	43	43
Follow-up (5 Weeks) COMPLETED	43	43
Follow-up (5 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Period 1 (12 Weeks) Adverse event, not serious	0	1
Period 2 (12 Weeks) Protocol Deviation	0	1

Baseline Characteristics

Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Daily Genotropin Then Weekly Somatrogon n=43 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=44 Participants 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.	Total n=87 Participants Total of all reporting groups
Age, Continuous	10.8 Years STANDARD_DEVIATION 3.4 • n=5 Participants	10.7 Years STANDARD_DEVIATION 3.7 • n=7 Participants	10.7 Years STANDARD_DEVIATION 3.5 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	38 Participants n=7 Participants	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	42 Participants n=7 Participants	81 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants	42 Participants n=7 Participants	81 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: 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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=42 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=40 Participants 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.
Total Score Related to Overall Life Interference Assessed at Baseline, Using Dyad Clinical Outcomes Assessment 1 (DCOA 1) Questionnaire	29.5 units on a scale Standard Deviation 18.0	27.1 units on a scale Standard Deviation 19.8

PRIMARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=43 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=40 Participants 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.
Total Score Related to Overall Life Interference Assessed at Week 12, Using DCOA 1 Questionnaire	25.2 units on a scale Standard Deviation 17.3	7.1 units on a scale Standard Deviation 7.8

PRIMARY outcome

Timeframe: Week 24

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=42 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=42 Participants 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.
Total Score Related to Overall Life Interference Assessed at Week 24, Using DCOA 1 Questionnaire	9.5 units on a scale Standard Deviation 13.3	23.0 units on a scale Standard Deviation 22.6

PRIMARY outcome

Timeframe: Baseline up to Week 24

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=85 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=82 Participants 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.
Total Score Related to Overall Life Interference by Treatment in Overall Study, Using DCOA 1 Questionnaire	24.13 units on a scale Interval 20.61 to 27.65	8.63 units on a scale Interval 5.05 to 12.22

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=43 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=44 Participants 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.
Total Score Related to Pen Ease of Use Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Baseline	10.6 units on a scale Standard Deviation 11.3	11.6 units on a scale Standard Deviation 12.8
Total Score Related to Pen Ease of Use Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Week 12	12.0 units on a scale Standard Deviation 13.8	5.1 units on a scale Standard Deviation 7.6
Total Score Related to Pen Ease of Use Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Week 24	5.5 units on a scale Standard Deviation 9.3	9.4 units on a scale Standard Deviation 13.0

SECONDARY outcome

Timeframe: Baseline up to Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=85 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=82 Participants 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.
Total Score Related to Pen Ease of Use by Treatment in Overall Study, Using DCOA 1 Questionnaire	10.71 units on a scale Interval 8.27 to 13.14	5.32 units on a scale Interval 2.84 to 7.8

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=43 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=44 Participants 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.
Total Score Related to Ease of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Baseline	18.5 units on a scale Standard Deviation 20.0	16.3 units on a scale Standard Deviation 17.5
Total Score Related to Ease of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Week 12	23.3 units on a scale Standard Deviation 25.2	4.4 units on a scale Standard Deviation 11.2
Total Score Related to Ease of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Week 24	9.5 units on a scale Standard Deviation 18.3	17.9 units on a scale Standard Deviation 22.3

SECONDARY outcome

Timeframe: Baseline up to Week 24

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=85 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=82 Participants 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.
Total Score Related to Ease of the Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire	20.56 units on a scale Interval 16.22 to 24.89	6.96 units on a scale Interval 2.54 to 11.37

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=43 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=44 Participants 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.
Total Score Related to Convenience of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Week 12	35.3 units on a scale Standard Deviation 23.9	7.9 units on a scale Standard Deviation 10.7
Total Score Related to Convenience of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Baseline	34.5 units on a scale Standard Deviation 21.0	32.5 units on a scale Standard Deviation 21.3
Total Score Related to Convenience of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Week 24	11.9 units on a scale Standard Deviation 14.4	33.3 units on a scale Standard Deviation 24.1

SECONDARY outcome

Timeframe: Baseline up to Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=85 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=82 Participants 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.
Total Score Related to Convenience of the Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire	34.30 units on a scale Interval 30.13 to 38.47	9.96 units on a scale Interval 5.71 to 14.21

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=43 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=44 Participants 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.
Total Score Related to Satisfaction With Overall Treatment Experience Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Baseline	28.0 units on a scale Standard Deviation 21.5	29.4 units on a scale Standard Deviation 23.3
Total Score Related to Satisfaction With Overall Treatment Experience Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Week 12	27.3 units on a scale Standard Deviation 27.2	20.0 units on a scale Standard Deviation 31.1
Total Score Related to Satisfaction With Overall Treatment Experience Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Week 24	22.0 units on a scale Standard Deviation 32.3	30.4 units on a scale Standard Deviation 27.9

SECONDARY outcome

Timeframe: Baseline up to Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=85 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=82 Participants 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.
Total Score Related to Satisfaction With Overall Treatment Experience by Treatment in Overall Study, Using DCOA 1 Questionnaire	28.95 units on a scale Interval 22.55 to 35.36	21.13 units on a scale Interval 14.61 to 27.65

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=43 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=44 Participants 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.
Total Scores Related to Willingness to Continue Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Baseline	18.5 units on a scale Standard Deviation 20.0	22.5 units on a scale Standard Deviation 23.9
Total Scores Related to Willingness to Continue Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Week 12	28.5 units on a scale Standard Deviation 27.6	10.6 units on a scale Standard Deviation 21.1
Total Scores Related to Willingness to Continue Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Week 24	13.1 units on a scale Standard Deviation 24.8	30.4 units on a scale Standard Deviation 29.0

SECONDARY outcome

Timeframe: Baseline up to Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=85 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=82 Participants 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.
Total Scores Related to Willingness to Continue Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire	29.54 units on a scale Interval 23.95 to 35.12	11.93 units on a scale Interval 6.24 to 17.62

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=35 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=34 Participants 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.
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 Baseline	15.0 units on a scale Standard Deviation 10.4	13.8 units on a scale Standard Deviation 11.9
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 Week 12	16.2 units on a scale Standard Deviation 12.2	13.7 units on a scale Standard Deviation 10.3
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 Week 24	13.6 units on a scale Standard Deviation 12.2	10.9 units on a scale Standard Deviation 9.6

SECONDARY outcome

Timeframe: Baseline up to Week 24

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=66 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=57 Participants 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.
Total Scores Related to Injection Signs and Symptoms for Participants Aged 8 Years and Above by Treatment in Overall Study, Using DCOA 1 Questionnaire	13.56 units on a scale Interval 10.78 to 16.34	14.27 units on a scale Interval 11.32 to 17.21

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=8 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=10 Participants 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.
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 Baseline	14.2 units on a scale Standard Deviation 14.6	13.5 units on a scale Standard Deviation 11.3
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 Week 12	9.3 units on a scale Standard Deviation 10.6	13.0 units on a scale Standard Deviation 15.8
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 Week 24	5.6 units on a scale Standard Deviation 7.8	9.4 units on a scale Standard Deviation 8.8

SECONDARY outcome

Timeframe: Baseline up to Week 24

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=16 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=18 Participants 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.
Total Scores Related to Assessment of Signs, Completed by Caregiver for Children Aged <8 Years by Treatment in Overall Study, Using DCOA 1 Questionnaire	8.75 units on a scale Interval 2.65 to 14.86	9.31 units on a scale Interval 3.47 to 15.16

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

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).

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=43 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=44 Participants 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.
Total Scores Related to Caregiver Life Interference, Including Family Life Interference Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Baseline	17.8 units on a scale Standard Deviation 17.5	20.0 units on a scale Standard Deviation 20.1
Total Scores Related to Caregiver Life Interference, Including Family Life Interference Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Week 12	15.9 units on a scale Standard Deviation 16.7	3.1 units on a scale Standard Deviation 5.5
Total Scores Related to Caregiver Life Interference, Including Family Life Interference Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Week 24	3.8 units on a scale Standard Deviation 6.0	18.1 units on a scale Standard Deviation 23.4

SECONDARY outcome

Timeframe: Baseline up to Week 24

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=85 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=82 Participants 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.
Total Scores Related to Caregiver Life Interference, Including Family Life Interference by Treatment in Overall Study, Using DCOA 1 Questionnaire	17.01 units on a scale Interval 13.77 to 20.25	3.54 units on a scale Interval 0.24 to 6.84

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=43 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=44 Participants 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.
Total Scores Related to Missed Injections Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Baseline	7.8 units on a scale Standard Deviation 15.1	7.3 units on a scale Standard Deviation 16.1
Total Scores Related to Missed Injections Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Week 12	4.3 units on a scale Standard Deviation 8.2	0.0 units on a scale Standard Deviation 0.0
Total Scores Related to Missed Injections Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire Week 24	1.9 units on a scale Standard Deviation 7.4	3.1 units on a scale Standard Deviation 10.8

SECONDARY outcome

Timeframe: Baseline up to Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=85 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=82 Participants 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.
Total Scores Related to Missed Injections by Treatment in Overall Study, Using DCOA 1 Questionnaire	3.71 units on a scale Interval 2.03 to 5.39	0.95 units on a scale Interval -0.76 to 2.66

SECONDARY outcome

Timeframe: Week 24

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).

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=42 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=42 Participants 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.
Number of Participants as Per Responses to Choice of Injection Pen Assessed at Week 24, Using DCOA 2 Questionnaire Somatrogon	38 Participants	36 Participants
Number of Participants as Per Responses to Choice of Injection Pen Assessed at Week 24, Using DCOA 2 Questionnaire Genotropin	4 Participants	6 Participants

SECONDARY outcome

Timeframe: Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=42 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=42 Participants 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.
Number of Participants as Per Responses to Preferred Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire Somatrogon	40 Participants	37 Participants
Number of Participants as Per Responses to Preferred Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire No Preference	0 Participants	1 Participants
Number of Participants as Per Responses to Preferred Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire Genotropin	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=42 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=42 Participants 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.
Number of Participants as Per Responses to Convenience of the Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire Somatrogon	40 Participants	40 Participants
Number of Participants as Per Responses to Convenience of the Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire Genotropin	2 Participants	2 Participants
Number of Participants as Per Responses to Convenience of the Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire No Difference	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=42 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=42 Participants 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.
Number of Participants as Per Responses to Ease of Following Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire Somatrogon	38 Participants	34 Participants
Number of Participants as Per Responses to Ease of Following Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire Genotropin	4 Participants	4 Participants
Number of Participants as Per Responses to Ease of Following Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire No Difference	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=42 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=42 Participants 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.
Number of Participants as Per Responses to Pen Ease of Use Assessed at Week 24, Using DCOA 2 Questionnaire Part I: Somatrogon	29 Participants	25 Participants
Number of Participants as Per Responses to Pen Ease of Use Assessed at Week 24, Using DCOA 2 Questionnaire Part I: Genotropin	3 Participants	4 Participants
Number of Participants as Per Responses to Pen Ease of Use Assessed at Week 24, Using DCOA 2 Questionnaire Part II: Somatrogon	21 Participants	17 Participants
Number of Participants as Per Responses to Pen Ease of Use Assessed at Week 24, Using DCOA 2 Questionnaire Part II: Genotropin	6 Participants	8 Participants
Number of Participants as Per Responses to Pen Ease of Use Assessed at Week 24, Using DCOA 2 Questionnaire Part III: Somatrogon	13 Participants	18 Participants
Number of Participants as Per Responses to Pen Ease of Use Assessed at Week 24, Using DCOA 2 Questionnaire Part III: Genotropin	16 Participants	12 Participants
Number of Participants as Per Responses to Pen Ease of Use Assessed at Week 24, Using DCOA 2 Questionnaire Part III: No Difference	13 Participants	12 Participants
Number of Participants as Per Responses to Pen Ease of Use Assessed at Week 24, Using DCOA 2 Questionnaire Part IV: Genotropin	2 Participants	2 Participants
Number of Participants as Per Responses to Pen Ease of Use Assessed at Week 24, Using DCOA 2 Questionnaire Part IV: No Difference	28 Participants	26 Participants
Number of Participants as Per Responses to Pen Ease of Use Assessed at Week 24, Using DCOA 2 Questionnaire Part I: No difference	10 Participants	13 Participants
Number of Participants as Per Responses to Pen Ease of Use Assessed at Week 24, Using DCOA 2 Questionnaire Part II: No Difference	15 Participants	17 Participants
Number of Participants as Per Responses to Pen Ease of Use Assessed at Week 24, Using DCOA 2 Questionnaire Part IV: Somatrogon	12 Participants	14 Participants

SECONDARY outcome

Timeframe: Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=42 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=42 Participants 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.
Number of Participants as Per Responses to Participant Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 1: No Difference	5 Participants	10 Participants
Number of Participants as Per Responses to Participant Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 2: Somatrogon	34 Participants	34 Participants
Number of Participants as Per Responses to Participant Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 2: No Difference	6 Participants	8 Participants
Number of Participants as Per Responses to Participant Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 3: Genotropin	2 Participants	1 Participants
Number of Participants as Per Responses to Participant Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 4: Somatrogon	36 Participants	37 Participants
Number of Participants as Per Responses to Participant Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 4: Genotropin	2 Participants	1 Participants
Number of Participants as Per Responses to Participant Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 4: No Difference	4 Participants	4 Participants
Number of Participants as Per Responses to Participant Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 1: Somatrogon	35 Participants	31 Participants
Number of Participants as Per Responses to Participant Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 1: Genotropin	2 Participants	1 Participants
Number of Participants as Per Responses to Participant Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 2: Genotropin	2 Participants	0 Participants
Number of Participants as Per Responses to Participant Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 3: Somatrogon	34 Participants	33 Participants
Number of Participants as Per Responses to Participant Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 3: No Difference	6 Participants	8 Participants
Number of Participants as Per Responses to Participant Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 5: Somatrogon	33 Participants	37 Participants
Number of Participants as Per Responses to Participant Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 5: Genotropin	3 Participants	0 Participants
Number of Participants as Per Responses to Participant Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 5: No Difference	6 Participants	5 Participants

SECONDARY outcome

Timeframe: Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=42 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=42 Participants 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.
Number of Participants as Per Responses to Caregiver Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 1: Genotropin	2 Participants	0 Participants
Number of Participants as Per Responses to Caregiver Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 3: No Difference	5 Participants	8 Participants
Number of Participants as Per Responses to Caregiver Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 4: Somatrogon	35 Participants	37 Participants
Number of Participants as Per Responses to Caregiver Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 1: Somatrogon	36 Participants	31 Participants
Number of Participants as Per Responses to Caregiver Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 1: No Difference	4 Participants	11 Participants
Number of Participants as Per Responses to Caregiver Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 2: Somatrogon	36 Participants	32 Participants
Number of Participants as Per Responses to Caregiver Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 2: Genotropin	2 Participants	0 Participants
Number of Participants as Per Responses to Caregiver Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 2: No Difference	4 Participants	10 Participants
Number of Participants as Per Responses to Caregiver Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 3: Somatrogon	35 Participants	34 Participants
Number of Participants as Per Responses to Caregiver Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 3: Genotropin	2 Participants	0 Participants
Number of Participants as Per Responses to Caregiver Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 4: Genotropin	1 Participants	0 Participants
Number of Participants as Per Responses to Caregiver Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 4: No Difference	6 Participants	5 Participants
Number of Participants as Per Responses to Caregiver Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 5: Somatrogon	35 Participants	37 Participants
Number of Participants as Per Responses to Caregiver Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 5: Genotropin	2 Participants	0 Participants
Number of Participants as Per Responses to Caregiver Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 5: No Difference	5 Participants	5 Participants

SECONDARY outcome

Timeframe: Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=42 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=42 Participants 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.
Number of Participants as Per Responses to Family Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 3: No Difference	9 Participants	10 Participants
Number of Participants as Per Responses to Family Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 5: Somatrogon	31 Participants	36 Participants
Number of Participants as Per Responses to Family Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 5: No Difference	10 Participants	6 Participants
Number of Participants as Per Responses to Family Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 1: Somatrogon	32 Participants	29 Participants
Number of Participants as Per Responses to Family Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 1: Genotropin	1 Participants	0 Participants
Number of Participants as Per Responses to Family Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 1: No Difference	9 Participants	13 Participants
Number of Participants as Per Responses to Family Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 2: Somatrogon	32 Participants	30 Participants
Number of Participants as Per Responses to Family Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 2: Genotropin	1 Participants	0 Participants
Number of Participants as Per Responses to Family Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 2: No Difference	9 Participants	12 Participants
Number of Participants as Per Responses to Family Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 3: Somatrogon	32 Participants	32 Participants
Number of Participants as Per Responses to Family Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 3: Genotropin	1 Participants	0 Participants
Number of Participants as Per Responses to Family Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 4: Somatrogon	31 Participants	34 Participants
Number of Participants as Per Responses to Family Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 4: Genotropin	1 Participants	0 Participants
Number of Participants as Per Responses to Family Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 4: No Difference	10 Participants	8 Participants
Number of Participants as Per Responses to Family Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire Activity 5: Genotropin	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=42 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=42 Participants 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.
Number of Participants as Per Response to Benefit Relating to the Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire Extremely Beneficial	28 Participants	20 Participants
Number of Participants as Per Response to Benefit Relating to the Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire Not At All Beneficial	2 Participants	2 Participants
Number of Participants as Per Response to Benefit Relating to the Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire Very Beneficial	11 Participants	14 Participants
Number of Participants as Per Response to Benefit Relating to the Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire Moderately Beneficial	1 Participants	3 Participants
Number of Participants as Per Response to Benefit Relating to the Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire Slightly Beneficial	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=42 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=42 Participants 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.
Number of Participants as Per Responses to Intention to Comply Assessed at Week 24, Using DCOA 2 Questionnaire Question 4: No Difference	13 Participants	9 Participants
Number of Participants as Per Responses to Intention to Comply Assessed at Week 24, Using DCOA 2 Questionnaire Question 1: Somatrogon	33 Participants	31 Participants
Number of Participants as Per Responses to Intention to Comply Assessed at Week 24, Using DCOA 2 Questionnaire Question 1: Genotropin	2 Participants	2 Participants
Number of Participants as Per Responses to Intention to Comply Assessed at Week 24, Using DCOA 2 Questionnaire Question 1: No Difference	7 Participants	9 Participants
Number of Participants as Per Responses to Intention to Comply Assessed at Week 24, Using DCOA 2 Questionnaire Question 2: Somatrogon	29 Participants	32 Participants
Number of Participants as Per Responses to Intention to Comply Assessed at Week 24, Using DCOA 2 Questionnaire Question 2: Genotropin	1 Participants	2 Participants
Number of Participants as Per Responses to Intention to Comply Assessed at Week 24, Using DCOA 2 Questionnaire Question 2: No Difference	12 Participants	8 Participants
Number of Participants as Per Responses to Intention to Comply Assessed at Week 24, Using DCOA 2 Questionnaire Question 3: Somatrogon	34 Participants	35 Participants
Number of Participants as Per Responses to Intention to Comply Assessed at Week 24, Using DCOA 2 Questionnaire Question 3: Genotropin	1 Participants	1 Participants
Number of Participants as Per Responses to Intention to Comply Assessed at Week 24, Using DCOA 2 Questionnaire Question 3: No Difference	7 Participants	6 Participants
Number of Participants as Per Responses to Intention to Comply Assessed at Week 24, Using DCOA 2 Questionnaire Question 4: Somatrogon	26 Participants	31 Participants
Number of Participants as Per Responses to Intention to Comply Assessed at Week 24, Using DCOA 2 Questionnaire Question 4: Genotropin	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12, 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).

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=43 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=44 Participants 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.
Patient Global Impression Severity-Impact on Daily Activities (PGIS-IDA) Score Assessed at Baseline, Week 12 and Week 24 Baseline	15.0 units on a scale Standard Deviation 14.8	16.3 units on a scale Standard Deviation 16.2
Patient Global Impression Severity-Impact on Daily Activities (PGIS-IDA) Score Assessed at Baseline, Week 12 and Week 24 Week 12	19.0 units on a scale Standard Deviation 19.4	4.6 units on a scale Standard Deviation 7.5
Patient Global Impression Severity-Impact on Daily Activities (PGIS-IDA) Score Assessed at Baseline, Week 12 and Week 24 Week 24	7.1 units on a scale Standard Deviation 9.8	22.2 units on a scale Standard Deviation 20.4

SECONDARY outcome

Timeframe: Baseline up to Week 24

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=85 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=82 Participants 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.
Patient Global Impression Severity-Impact on Daily Activities (PGIS-IDA) Score by Treatment in Overall Study	20.64 units on a scale Interval 17.3 to 23.99	6.06 units on a scale Interval 2.66 to 9.46

OTHER_PRE_SPECIFIED outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=86 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=87 Participants 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.
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Emergent Treatment Related AEs and SAEs Treatment-Emergent AEs	38 Participants	47 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Emergent Treatment Related AEs and SAEs Treatment-Emergent SAEs	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Emergent Treatment Related AEs and SAEs Treatment-Emergent Related AEs	14 Participants	21 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Emergent Treatment Related AEs and SAEs Treatment-Emergent Related SAEs	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

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

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=86 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=87 Participants 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.
Number of Participants With Adverse Events According to Severity Mild	34 Participants	41 Participants
Number of Participants With Adverse Events According to Severity Moderate	4 Participants	6 Participants
Number of Participants With Adverse Events According to Severity Severe	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=86 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=87 Participants 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.
Number of Participants With Discontinuation Due to Adverse Events (AEs)	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 1 to Week 12, Week 13 to Week 24

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.

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=43 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=44 Participants 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.
Number of Participants With Laboratory Abnormalities Week 13 to Week 24	24 Participants	21 Participants
Number of Participants With Laboratory Abnormalities Week 1 to Week 12	19 Participants	19 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 12, Week 24

Population: 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.

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

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=43 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=44 Participants 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.
Number of Participants With Positive Anti-Recombinant Human Growth Hormone (rhGH) Antibodies and Neutralizing Antibodies (NAb) Baseline: Anti-rhGH	5 Participants	0 Participants
Number of Participants With Positive Anti-Recombinant Human Growth Hormone (rhGH) Antibodies and Neutralizing Antibodies (NAb) Baseline: Neutralizing	0 Participants	0 Participants
Number of Participants With Positive Anti-Recombinant Human Growth Hormone (rhGH) Antibodies and Neutralizing Antibodies (NAb) Week 12: Anti-rhGH	3 Participants	3 Participants
Number of Participants With Positive Anti-Recombinant Human Growth Hormone (rhGH) Antibodies and Neutralizing Antibodies (NAb) Week 12: Neutralizing	0 Participants	0 Participants
Number of Participants With Positive Anti-Recombinant Human Growth Hormone (rhGH) Antibodies and Neutralizing Antibodies (NAb) Week 24: Anti-rhGH	4 Participants	6 Participants
Number of Participants With Positive Anti-Recombinant Human Growth Hormone (rhGH) Antibodies and Neutralizing Antibodies (NAb) Week 24: Neutralizing	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 12, Week 24

Population: 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.

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

Outcome measures

Outcome measures
Measure	Daily Genotropin Then Weekly Somatrogon n=43 Participants 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.	Weekly Somatrogon Then Daily Genotropin n=44 Participants 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.
Number of Participants With Positive Anti-Somatrogon Antibodies and Neutralizing Antibodies (NAb) Baseline: Neutralizing	0 Participants	0 Participants
Number of Participants With Positive Anti-Somatrogon Antibodies and Neutralizing Antibodies (NAb) Week 24: Anti-Somatrogon Antibodies	0 Participants	—
Number of Participants With Positive Anti-Somatrogon Antibodies and Neutralizing Antibodies (NAb) Baseline: Anti-Somatrogon Antibodies	0 Participants	0 Participants
Number of Participants With Positive Anti-Somatrogon Antibodies and Neutralizing Antibodies (NAb) Week 12: Anti-Somatrogon Antibodies	—	4 Participants
Number of Participants With Positive Anti-Somatrogon Antibodies and Neutralizing Antibodies (NAb) Week 12: Neutralizing	—	0 Participants
Number of Participants With Positive Anti-Somatrogon Antibodies and Neutralizing Antibodies (NAb) Week 24: Neutralizing	0 Participants	—

Adverse Events

Genotropin

Serious events: 0 serious events

Other events: 38 other events

Deaths: 0 deaths

Somatrogon

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER