A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

Incidence of Adverse Events, Including Injection Site Reactions

Time frame · Weeks 0-53

An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which did not necessarily have a causal relationship with the treatment. Rate of AEs per 100 patient years at risk with onset after the first administration of trial product and up until end of the trial (53 weeks) or 14 days after last trial drug administration, whichever came first, are presented.

Change in Cross-sectional Total Adipose Tissue Compartments

Time frame · Week 0, week 52

Cross-sectional total adipose tissue compartments (TAT) were determined by quantitative computed tomography (CT) scans. Change from baseline (week 0) to end of treatment period (52 weeks) in cross-sectional TAT compartments is presented.

Change in Subcutaneous Adipose Tissue Compartments

Time frame · Week 0, week 52

Subcutaneous adipose tissue compartments (SAT) was determined by quantitative CT scans. Change from baseline (week 0) to end of treatment period (52 weeks) in SAT compartments is presented.

Change in Intra-abdominal or Visceral Adipose Tissue Compartments

Time frame · Week 0, week 52

Intra-abdominal or visceral adipose tissue (VAT) compartments was determined by quantitative CT scans. Change from baseline (week 0) to end of treatment period (52 weeks) in VAT compartments is presented.

Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores

Time frame · Week 0, week 52

The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effectiveness of the medication, convenience and global satisfaction of treatment. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100. Change in TSQM-9 scores from baseline (week 0) to week 52 are presented.

Change in Physical Examination

Time frame · Week 0, week 52

Physical examination parameters were evaluated for head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system, gastrointestinal system, incl. mouth; musculoskeletal system; nervous system (central and peripheral); skin; and lymph node palpation. The investigator evaluated the findings from the physical examination and classifies them as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS). Results are presented for week 0 and week 52.

Change in Body Weight

Time frame · Week -3, week 52

Change from baseline (week -3) in body weight at week 52 is presented.

Change in SBP and DBP

Time frame · Week 0, week 52

Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at week 52 is presented.

Change in Pulse

Time frame · Week 0, week 52

Change from baseline (week 0) in pulse at week 52 is presented.

Change in ECG

Time frame · Week -3, week 52

The ECG was assessed by the investigator at baseline (week -3) and week 52 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at week -3 and week 52 are presented.

Change in Haematology: Haemoglobin

Time frame · Week -3, week 52

Change from baseline (week -3) in haemoglobin at week 52 is presented.