Trial Outcomes & Findings for Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm (NCT NCT00163189)

NCT ID: NCT00163189

Last Updated: 2024-02-21

Results Overview

Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 98 participants
• Primary outcome timeframe: Baseline, Month 36
• Results posted on: 2024-02-21

Participant Flow

The reason 'Study Terminated by Sponsor' mentioned in the participant flow indicates the termination of study at a site (due to Good Clinical Practice [GCP] compliance issues) and does not reflect the overall status of study.

Participant milestones

Measure	Genotonorm Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Overall Study STARTED	98
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	63

Reasons for withdrawal

Measure	Genotonorm Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Overall Study Other	6
Overall Study Lost to Follow-up	1
Overall Study Protocol Violation	2
Overall Study Death	3
Overall Study Adverse Event	6
Overall Study Lack of Efficacy	7
Overall Study Study terminated by sponsor	11
Overall Study Withdrawal by Subject	11
Overall Study Did not meet continuation criterion	16

Baseline Characteristics

Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm

Baseline characteristics by cohort

Measure	Genotonorm n=98 Participants Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Age, Continuous	11.8 years STANDARD_DEVIATION 3.2 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 36

Population: Full analysis set (FAS) included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point.

Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12.

Outcome measures

Measure	Genotonorm n=58 Participants Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population Baseline (n=58)	-2.91 Standard Deviation Score (SDS) Standard Deviation 1.19
Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population Change at Month 36 (n=30)	0.80 Standard Deviation Score (SDS) Standard Deviation 1.03

PRIMARY outcome

Timeframe: Baseline, Month 36

Population: PP analysis set included all participants (excluding a site with GCP issues) who received at least 1 dose of GH, had at least 1 subsequent rating of height, no major protocol violation till first 3 years post initiation of treatment and total GH treatment duration of 36 months or more. "n"=participants evaluable at the specified time point.

Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12.

Outcome measures

Measure	Genotonorm n=21 Participants Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population Baseline (n=21)	-2.86 SDS Standard Deviation 0.89
Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population Change at Month 36 (n=19)	0.81 SDS Standard Deviation 1.18

SECONDARY outcome

Timeframe: Baseline, Month 12, 24, 36, 48, 60

Population: FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point.

The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.

Outcome measures

Measure	Genotonorm n=58 Participants Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Mean Height Month 60 (n=9)	156.0 centimeters (cm) Standard Deviation 11.3
Mean Height Baseline (n=58)	133.9 centimeters (cm) Standard Deviation 15.7
Mean Height Month 12 (n=50)	139.5 centimeters (cm) Standard Deviation 16.8
Mean Height Month 24 (n=41)	146.0 centimeters (cm) Standard Deviation 16.4
Mean Height Month 36 (n=30)	150.4 centimeters (cm) Standard Deviation 16.0
Mean Height Month 48 (n=14)	152.4 centimeters (cm) Standard Deviation 16.0

SECONDARY outcome

Timeframe: Baseline, Month 12, 24, 36, 48, 60

Population: FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point.

The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand.

Outcome measures

Measure	Genotonorm n=58 Participants Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Mean Height Standard Deviation Score (SDS) for Bone Age (BA) Baseline (n=51)	-0.29 SDS Standard Deviation 1.15
Mean Height Standard Deviation Score (SDS) for Bone Age (BA) Month 12 (n=40)	-0.36 SDS Standard Deviation 1.52
Mean Height Standard Deviation Score (SDS) for Bone Age (BA) Month 24 (n=29)	0.11 SDS Standard Deviation 1.36
Mean Height Standard Deviation Score (SDS) for Bone Age (BA) Month 36 (n=24)	0.14 SDS Standard Deviation 1.48
Mean Height Standard Deviation Score (SDS) for Bone Age (BA) Month 48 (n=13)	-0.26 SDS Standard Deviation 1.28
Mean Height Standard Deviation Score (SDS) for Bone Age (BA) Month 60 (n=7)	-0.19 SDS Standard Deviation 1.15

SECONDARY outcome

Timeframe: Baseline, Month 12, 24, 36, 48, 60

Population: FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point.

AGR at Yx was derived by subtracting AGR at baseline from Yx value. AGR was calculated each year and re scaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y[x-1]) and height recorded at Yx (AGR Yx = [height Yx-height Y{x-1}] / ([date of Yx - date of Y{x-1}] /365.25). Yx refers to the value at particular timepoint x.

Outcome measures

Measure	Genotonorm n=58 Participants Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Annual Growth Rate (AGR) Baseline (n=52)	3.0 cm/year Standard Deviation 2.0
Annual Growth Rate (AGR) Month 12 (n=49)	6.7 cm/year Standard Deviation 2.6
Annual Growth Rate (AGR) Month 24 (n=41)	6.0 cm/year Standard Deviation 2.7
Annual Growth Rate (AGR) Month 36 (n=30)	5.9 cm/year Standard Deviation 2.7
Annual Growth Rate (AGR) Month 48 (n=14)	4.8 cm/year Standard Deviation 2.5
Annual Growth Rate (AGR) Month 60 (n=9)	4.9 cm/year Standard Deviation 3.0

SECONDARY outcome

Timeframe: Month 12, 24, 36, 48, 60

Population: FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point.

GR SDS BA Yx = (GR Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. BA was estimated locally using an X-ray from the left wrist and hand.

Outcome measures

Measure	Genotonorm n=58 Participants Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA) Month 48 (n=11)	-1.00 SDS Standard Deviation 1.38
Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA) Month 12 (n=36)	-0.13 SDS Standard Deviation 2.15
Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA) Month 24 (n=25)	0.07 SDS Standard Deviation 2.51
Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA) Month 36 (n=20)	0.05 SDS Standard Deviation 1.94
Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA) Month 60 (n=7)	-0.43 SDS Standard Deviation 1.22

SECONDARY outcome

Timeframe: Baseline, Month 12, 24, 36, 48, 60

Population: FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point.

GR SDS CA Yx = (GR Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12.

Outcome measures

Measure	Genotonorm n=58 Participants Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA) Baseline (n=52)	-2.04 SDS Standard Deviation 2.03
Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA) Month 12 (n=49)	1.77 SDS Standard Deviation 4.29
Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA) Month 24 (n=41)	5.26 SDS Standard Deviation 16.79
Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA) Month 36 (n=29)	3.64 SDS Standard Deviation 9.06
Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA) Month 48 (n=13)	0.93 SDS Standard Deviation 2.73
Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA) Month 60 (n=9)	1.40 SDS Standard Deviation 1.71

SECONDARY outcome

Timeframe: Baseline, Month 12, 24, 36, 48, 60

Population: FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point.

BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2).

Outcome measures

Measure	Genotonorm n=58 Participants Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Body Mass Index (BMI) Baseline (n=58)	19.4 kg/m^2 Standard Deviation 3.6
Body Mass Index (BMI) Month 12 (n=50)	19.1 kg/m^2 Standard Deviation 3.1
Body Mass Index (BMI) Month 24 (n=41)	19.4 kg/m^2 Standard Deviation 3.0
Body Mass Index (BMI) Month 36 (n=30)	19.4 kg/m^2 Standard Deviation 2.4
Body Mass Index (BMI) Month 48 (n=14)	19.7 kg/m^2 Standard Deviation 3.0
Body Mass Index (BMI) Month 60 (n=9)	20.8 kg/m^2 Standard Deviation 3.3

SECONDARY outcome

Timeframe: Baseline, Month 12, 24, 36, 48, 60

Population: FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point.

The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.

Outcome measures

Measure	Genotonorm n=58 Participants Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Change From Baseline in Height at Month 12, 24, 36, 48 and 60 Baseline (n=58)	133.9 cm Standard Deviation 15.7
Change From Baseline in Height at Month 12, 24, 36, 48 and 60 Change at Month 12 (n=50)	6.8 cm Standard Deviation 2.8
Change From Baseline in Height at Month 12, 24, 36, 48 and 60 Change at Month 24 (n=41)	12.9 cm Standard Deviation 4.7
Change From Baseline in Height at Month 12, 24, 36, 48 and 60 Change at Month 36 (n=30)	18.8 cm Standard Deviation 6.1
Change From Baseline in Height at Month 12, 24, 36, 48 and 60 Change at Month 48 (n=14)	23.9 cm Standard Deviation 8.5
Change From Baseline in Height at Month 12, 24, 36, 48 and 60 Change at Month 60 (n=9)	30.3 cm Standard Deviation 7.6

SECONDARY outcome

Timeframe: Baseline, Month 12, 24, 48, 60

Population: FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point.

The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12.

Outcome measures

Measure	Genotonorm n=58 Participants Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60 Baseline (n=58)	-2.91 SDS Standard Deviation 1.19
Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60 Change at Month 12 (n=50)	0.28 SDS Standard Deviation 0.57
Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60 Change at Month 24 (n=41)	0.57 SDS Standard Deviation 0.95
Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60 Change at Month 48 (n=14)	0.82 SDS Standard Deviation 1.42
Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60 Change at Month 60 (n=9)	0.75 SDS Standard Deviation 1.13

SECONDARY outcome

Timeframe: Baseline, Month 12, 24, 36, 48, 60

Population: FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point.

The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand.

Outcome measures

Measure	Genotonorm n=58 Participants Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, 24, 36, 48 and 60 Baseline (n=51)	-0.29 SDS Standard Deviation 1.15
Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, 24, 36, 48 and 60 Change at Month 12 (n=36)	-0.02 SDS Standard Deviation 0.99
Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, 24, 36, 48 and 60 Change at Month 24 (n=26)	0.28 SDS Standard Deviation 1.18
Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, 24, 36, 48 and 60 Change at Month 36 (n=21)	0.31 SDS Standard Deviation 1.17
Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, 24, 36, 48 and 60 Change at Month 48 (n=13)	-0.08 SDS Standard Deviation 1.30
Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, 24, 36, 48 and 60 Change at Month 60 (n=7)	0.01 SDS Standard Deviation 1.33

SECONDARY outcome

Timeframe: Baseline, Month 12, 24, 36, 48, 60

Population: FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point.

BA was estimated locally using an X-ray from the left wrist and hand.

Outcome measures

Measure	Genotonorm n=58 Participants Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Change From Baseline in Bone Age (BA) at Month 12, 24, 36, 48 and 60 Change at Month 48 (n=13)	52.8 months Standard Deviation 21.2
Change From Baseline in Bone Age (BA) at Month 12, 24, 36, 48 and 60 Baseline (n=58)	117.9 months Standard Deviation 34.6
Change From Baseline in Bone Age (BA) at Month 12, 24, 36, 48 and 60 Change at Month 12 (n=37)	17.8 months Standard Deviation 11.0
Change From Baseline in Bone Age (BA) at Month 12, 24, 36, 48 and 60 Change at Month 24 (n=32)	28.2 months Standard Deviation 17.9
Change From Baseline in Bone Age (BA) at Month 12, 24, 36, 48 and 60 Change at Month 36 (n=23)	36.5 months Standard Deviation 17.8
Change From Baseline in Bone Age (BA) at Month 12, 24, 36, 48 and 60 Change at Month 60 (n=7)	70.0 months Standard Deviation 27.0

SECONDARY outcome

Timeframe: Baseline, Month 12, 24, 36, 48, 60

Population: FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here "n" signifies those participants who were evaluable for the specified time point.

BA was estimated locally using an X-ray from the left wrist and hand. CA at the date of corresponding X-ray (Date of X-ray - Date of birth)/365.25. Ratio of BA/CA at each annual study visit was calculated.

Outcome measures

Measure	Genotonorm n=58 Participants Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Ratio of Bone Age (BA) to Chronological Age (CA) Baseline (n=58)	0.78 ratio Standard Deviation 0.10
Ratio of Bone Age (BA) to Chronological Age (CA) Month 12 (n=37)	0.82 ratio Standard Deviation 0.11
Ratio of Bone Age (BA) to Chronological Age (CA) Month 24 (n=32)	0.80 ratio Standard Deviation 0.09
Ratio of Bone Age (BA) to Chronological Age (CA) Month 36 (n=23)	0.79 ratio Standard Deviation 0.10
Ratio of Bone Age (BA) to Chronological Age (CA) Month 48 (n=13)	0.81 ratio Standard Deviation 0.08
Ratio of Bone Age (BA) to Chronological Age (CA) Month 60 (n=7)	0.85 ratio Standard Deviation 0.10

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 28 days after last study treatment

Population: Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs include both SAEs and non-SAEs.

Outcome measures

Measure	Genotonorm n=98 Participants Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) AEs	84 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) SAEs	45 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Month 12, 24, 36, 48, 60, End of Treatment (EOT)

Population: Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.

Number of participants with clinically significant physical examinations changes since previous visit were reported. Physical examination including estimation of pubertal stage and blood pressure measurement;

Outcome measures

Measure	Genotonorm n=98 Participants Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Number of Participants With Significant Changes in Physical Examinations Baseline (n=93)	1 participants
Number of Participants With Significant Changes in Physical Examinations Month 12 (n=93)	16 participants
Number of Participants With Significant Changes in Physical Examinations Month 24 (n=72)	16 participants
Number of Participants With Significant Changes in Physical Examinations Month 36 (n=52)	5 participants
Number of Participants With Significant Changes in Physical Examinations Month 48 (n=23)	4 participants
Number of Participants With Significant Changes in Physical Examinations Month 60 (n=12)	2 participants
Number of Participants With Significant Changes in Physical Examinations EOT (n=44)	11 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening

Population: Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.

Outcome measures

Measure	Genotonorm n=98 Participants Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Number of Participants With at Least 1 Medical or Surgical History	67 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Month 60

Population: Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.

Outcome measures

Measure	Genotonorm n=98 Participants Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Number of Participants Who Received Concomitant Medications	98 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60

Population: Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.

Outcome measures

Measure	Genotonorm n=98 Participants Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels Month 36 (n=44)	511 nanogram per milliliter (ng/mL) Standard Deviation 186
Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels Screening (n=93)	335 nanogram per milliliter (ng/mL) Standard Deviation 157
Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels Month 6 (n=63)	604 nanogram per milliliter (ng/mL) Standard Deviation 291
Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels Month 12 (n=71)	538 nanogram per milliliter (ng/mL) Standard Deviation 268
Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels Month 18 (n=47)	624 nanogram per milliliter (ng/mL) Standard Deviation 251
Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels Month 24 (n=62)	579 nanogram per milliliter (ng/mL) Standard Deviation 262
Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels Month 30 (n=50)	559 nanogram per milliliter (ng/mL) Standard Deviation 250
Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels Month 42 (n=22)	555 nanogram per milliliter (ng/mL) Standard Deviation 224
Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels Month 48 (n=21)	581 nanogram per milliliter (ng/mL) Standard Deviation 244
Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels Month 54 (n=16)	593 nanogram per milliliter (ng/mL) Standard Deviation 184
Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels Month 60 (n=10)	501 nanogram per milliliter (ng/mL) Standard Deviation 180

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening, Month 12, 24, 36, 48, 60

Population: Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.

Fasting and 2 hours plasma glucose levels were assessed using standard oral glucose tolerance test (OGTT).

Outcome measures

Measure	Genotonorm n=98 Participants Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60 Glucose Postprandial: Month 12 (n=66)	6.1 milli mole per liter (mmol/L) Standard Deviation 1.4
Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60 Glucose Fasting: Screening (n=91)	4.5 milli mole per liter (mmol/L) Standard Deviation 0.7
Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60 Glucose Fasting: Month 12 (n=69)	4.6 milli mole per liter (mmol/L) Standard Deviation 0.7
Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60 Glucose Fasting: Month 24 (n=59)	4.7 milli mole per liter (mmol/L) Standard Deviation 0.6
Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60 Glucose Fasting: Month 36 (n=45)	4.6 milli mole per liter (mmol/L) Standard Deviation 0.5
Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60 Glucose Fasting: Month 48 (n=20)	4.7 milli mole per liter (mmol/L) Standard Deviation 0.4
Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60 Glucose Fasting: Month 60 (n=14)	4.5 milli mole per liter (mmol/L) Standard Deviation 0.6
Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60 Glucose Postprandial: Screening (n=94)	5.6 milli mole per liter (mmol/L) Standard Deviation 1.2
Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60 Glucose Postprandial: Month 24 (n=59)	6.1 milli mole per liter (mmol/L) Standard Deviation 1.4
Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60 Glucose Postprandial: Month 36 (n=41)	6.4 milli mole per liter (mmol/L) Standard Deviation 1.6
Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60 Glucose Postprandial: Month 48 (n=19)	6.1 milli mole per liter (mmol/L) Standard Deviation 1.1
Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60 Glucose Postprandial: Month 60 (n=13)	6.3 milli mole per liter (mmol/L) Standard Deviation 1.5

Adverse Events

Genotonorm

Serious events: 45 serious events

Other events: 81 other events

Deaths: 0 deaths

Serious adverse events

Measure	Genotonorm n=98 participants at risk Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Infections and infestations Gastroenteritis	8.2% 8/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sepsis	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Varicella	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Cellulitis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Empedobacter brevis infection	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Erysipelas	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis cryptosporidial	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis rotavirus	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nail bed infection	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Periorbital cellulitis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pertussis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Skin infection	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tonsillitis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Nephrotic syndrome	7.1% 7/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure	5.1% 5/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Proteinuria	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Aphthous stomatitis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastritis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastrointestinal disorder	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Intestinal obstruction	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Protein-losing gastroenteropathy	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Rectal stenosis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Subileus	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Varices oesophageal	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Death	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Infusion site extravasation	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Benign intracranial hypertension	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Cerebral venous thrombosis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Intracranial pressure increased	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Optic neuritis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Syncope vasovagal	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Abdominal injury	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Accident	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Alcohol poisoning	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Facial bones fracture	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fall	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Spinal compression fracture	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Upper limb fracture	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Epiphysiolysis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Joint destruction	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Knee deformity	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Osteochondrosis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Synovitis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperglycaemia	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Type 2 diabetes mellitus	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Cataract operation	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Gastrostomy closure	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Knee arthroplasty	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Thoracic operation	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Tooth extraction	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Cataract	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Glaucoma	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Uveitis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Visual acuity reduced	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypovolaemic shock	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Intermittent claudication	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Peripheral coldness	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Peripheral ischaemia	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Histiocytosis haematophagic	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Lymphadenitis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombotic microangiopathy	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiac failure	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiopulmonary failure	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Subvalvular aortic stenosis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin ulcer	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Toxic skin eruption	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Urticaria	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depression	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cytolytic hepatitis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Graft versus host disease	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Hypersensitivity	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Polycystic ovaries	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Social circumstances Treatment noncompliance	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Measure	Genotonorm n=98 participants at risk Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram \[mcg\]/kg/day) for up to 60 months.
Infections and infestations Bronchitis	8.2% 8/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	6.1% 6/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tonsillitis	6.1% 6/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis	5.1% 5/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pharyngitis	5.1% 5/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Influenza	4.1% 4/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Rhinitis	4.1% 4/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Varicella	4.1% 4/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Ear infection	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Otitis media	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Respiratory tract infection	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sinusitis	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tinea pedis	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Viral infection	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Chikungunya virus infection	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Cystitis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Dermatophytosis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Eye infection toxoplasmal	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Fungal skin infection	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gangrene	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Impetigo	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Oral fungal infection	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Paronychia	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Penile infection	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia mycoplasmal	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pyelonephritis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tinea versicolour	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tooth abscess	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tooth infection	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tracheitis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Trichophytosis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	9.2% 9/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	6.1% 6/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastritis	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Duodenitis	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gingivitis	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Odynophagia	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea haemorrhagic	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Enterocolitis haemorrhagic	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gingival hypertrophy	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Ileus	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Intestinal polyp	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Mouth ulceration	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Oral disorder	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Rectal haemorrhage	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Stomatitis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	9.2% 9/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	5.1% 5/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	5.1% 5/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Juvenile arthritis	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Scoliosis	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthritis	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Knee deformity	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Neck pain	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Amyotrophy	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Bone pain	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Joint effusion	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Joint stiffness	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Mobility decreased	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Osteoporosis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Tendonitis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Acne	6.1% 6/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin lesion	5.1% 5/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin striae	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermatomyositis	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Acanthosis nigricans	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Alopecia	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Cutaneous lupus erythematosus	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermal cyst	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Ecchymosis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Eczema	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Erythema	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Hypertrichosis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Ingrowing nail	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash macular	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Scar	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin nodule	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Swelling face	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	8.2% 8/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	7.1% 7/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Injection site pain	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Malaise	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Mucosal inflammation	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pain	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Cataract	4.1% 4/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Conjunctivitis	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Ocular hypertension	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Papilloedema	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Uveitis	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Chalazion	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Eye disorder	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Myopia	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Night blindness	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Periorbital disorder	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Retinal detachment	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Visual acuity reduced	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Visual impairment	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Vitritis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Insulin-like growth factor increased	13.3% 13/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Weight decreased	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood creatinine increased	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Transaminases increased	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Glucose tolerance impaired	8.2% 8/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Anorexia	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Diabetes mellitus	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperglycaemia	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypertriglyceridaemia	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypoglycaemia	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypokalaemia	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Obesity	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Nephrotic syndrome	11.2% 11/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Dysuria	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Enuresis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal impairment	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Proteinuria	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	6.1% 6/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Lung disorder	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Productive cough	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	8.2% 8/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hemicephalalgia	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hyperreflexia	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hypotonia	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Migraine	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Syncope	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Haemolysis	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Lymphadenopathy	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Anaemia	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Anaemia of chronic disease	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Lymphadenitis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Contusion	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Graft dysfunction	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Joint injury	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Joint sprain	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Spinal compression fracture	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Wound	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	4.1% 4/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acrochordon	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	4.1% 4/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Thrombosis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Affective disorder	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Sleep disorder	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depression	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Otorrhoea	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Tinnitus	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Vertigo	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Arrhythmia	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Hypertrophic cardiomyopathy	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Endocrine disorders Cushingoid	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Hypersensitivity	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Vasculitis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Gynaecomastia	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Congenital, familial and genetic disorders Sickle cell anaemia with crisis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cytolytic hepatitis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Hospitalisation	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pityriasis	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting 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