Trial Outcomes & Findings for A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults (NCT NCT01088399)

Last Updated: 2014-04-21

Results Overview

A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the Adverse Events module of this record.

Recruitment status

COMPLETED

Target enrollment

10673 participants

Primary outcome timeframe

Baseline to study completion (approximately 10 years)

Results posted on

2014-04-21

Participant Flow

Participants were initially enrolled in 2 regional observational studies (B9R-EW-GDDQ \[GDDQ\] initiated in 1997 and B9R-MC-GDEE \[GDEE\] in 1998) which were merged into the global Study B9R-MC-GDGA (GDGA, NCT01088399) in 2002. This record spans approximately 15 years from the initial enrollment in regional studies to completion of Study GDGA.

Participant milestones

Participant milestones
Measure	Somatropin Treated Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.	Untreated Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.	It is not known whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
Overall Study STARTED	8716	1655	302
Overall Study COMPLETED	1595	308	21
Overall Study NOT COMPLETED	7121	1347	281

Reasons for withdrawal

Reasons for withdrawal
Measure	Somatropin Treated Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.	Untreated Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.	It is not known whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
Overall Study Adverse Event	211	16	0
Overall Study Death	204	45	0
Overall Study Lack of Efficacy	298	7	5
Overall Study Lost to Follow-up	1070	278	58
Overall Study Physician Decision	531	88	16
Overall Study Withdrawal by Subject	544	195	33
Overall Study Change to or start of somatropin therapy	234	17	12
Overall Study Sponsor decision	1573	298	7
Overall Study Protocol Violation	10	1	0
Overall Study Enrollment criteria not met	48	119	70
Overall Study Study summary visit not completed	2398	283	80

Baseline Characteristics

A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Somatropin Treated n=8716 Participants Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.	Untreated n=1655 Participants Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.	Unknown n=302 Participants It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.	Total n=10673 Participants Total of all reporting groups
Age, Customized <20 years	421 participants n=99 Participants	36 participants n=107 Participants	10 participants n=206 Participants	467 participants n=7 Participants
Age, Customized 20 years to <30 years	1258 participants n=99 Participants	152 participants n=107 Participants	36 participants n=206 Participants	1446 participants n=7 Participants
Age, Customized 30 years to <40 years	1475 participants n=99 Participants	173 participants n=107 Participants	54 participants n=206 Participants	1702 participants n=7 Participants
Age, Customized 40 years to <50 years	1975 participants n=99 Participants	318 participants n=107 Participants	76 participants n=206 Participants	2369 participants n=7 Participants
Age, Customized 50 years to <60 years	2048 participants n=99 Participants	379 participants n=107 Participants	74 participants n=206 Participants	2501 participants n=7 Participants
Age, Customized 60 years to <70 years	1116 participants n=99 Participants	324 participants n=107 Participants	38 participants n=206 Participants	1478 participants n=7 Participants
Age, Customized >=70 years	421 participants n=99 Participants	272 participants n=107 Participants	13 participants n=206 Participants	706 participants n=7 Participants
Age, Customized unknown	2 participants n=99 Participants	1 participants n=107 Participants	1 participants n=206 Participants	4 participants n=7 Participants
Sex: Female, Male Female	4158 Participants n=99 Participants	714 Participants n=107 Participants	155 Participants n=206 Participants	5027 Participants n=7 Participants
Sex: Female, Male Male	4558 Participants n=99 Participants	941 Participants n=107 Participants	147 Participants n=206 Participants	5646 Participants n=7 Participants
Race/Ethnicity, Customized African Descent	226 participants n=99 Participants	96 participants n=107 Participants	14 participants n=206 Participants	336 participants n=7 Participants
Race/Ethnicity, Customized Caucasian	6058 participants n=99 Participants	1080 participants n=107 Participants	236 participants n=206 Participants	7374 participants n=7 Participants
Race/Ethnicity, Customized East/Southeast Asian	460 participants n=99 Participants	129 participants n=107 Participants	7 participants n=206 Participants	596 participants n=7 Participants
Race/Ethnicity, Customized Hispanic	153 participants n=99 Participants	55 participants n=107 Participants	16 participants n=206 Participants	224 participants n=7 Participants
Race/Ethnicity, Customized Western Asian	24 participants n=99 Participants	5 participants n=107 Participants	3 participants n=206 Participants	32 participants n=7 Participants
Race/Ethnicity, Customized Other	38 participants n=99 Participants	10 participants n=107 Participants	2 participants n=206 Participants	50 participants n=7 Participants
Race/Ethnicity, Customized Declined To Provide	387 participants n=99 Participants	82 participants n=107 Participants	12 participants n=206 Participants	481 participants n=7 Participants
Race/Ethnicity, Customized Unknown	1370 participants n=99 Participants	198 participants n=107 Participants	12 participants n=206 Participants	1580 participants n=7 Participants
Region of Enrollment Austria	77 participants n=99 Participants	1 participants n=107 Participants	1 participants n=206 Participants	79 participants n=7 Participants
Region of Enrollment Belgium	55 participants n=99 Participants	1 participants n=107 Participants	0 participants n=206 Participants	56 participants n=7 Participants
Region of Enrollment Canada	63 participants n=99 Participants	51 participants n=107 Participants	0 participants n=206 Participants	114 participants n=7 Participants
Region of Enrollment Czech Republic	77 participants n=99 Participants	5 participants n=107 Participants	0 participants n=206 Participants	82 participants n=7 Participants
Region of Enrollment Denmark	151 participants n=99 Participants	5 participants n=107 Participants	0 participants n=206 Participants	156 participants n=7 Participants
Region of Enrollment France	452 participants n=99 Participants	218 participants n=107 Participants	6 participants n=206 Participants	676 participants n=7 Participants
Region of Enrollment Germany	553 participants n=99 Participants	87 participants n=107 Participants	19 participants n=206 Participants	659 participants n=7 Participants
Region of Enrollment Hungary	102 participants n=99 Participants	2 participants n=107 Participants	0 participants n=206 Participants	104 participants n=7 Participants
Region of Enrollment Iceland	10 participants n=99 Participants	1 participants n=107 Participants	1 participants n=206 Participants	12 participants n=7 Participants
Region of Enrollment Italy	1242 participants n=99 Participants	64 participants n=107 Participants	49 participants n=206 Participants	1355 participants n=7 Participants
Region of Enrollment Japan	407 participants n=99 Participants	102 participants n=107 Participants	0 participants n=206 Participants	509 participants n=7 Participants
Region of Enrollment Norway	17 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants	17 participants n=7 Participants
Region of Enrollment Spain	427 participants n=99 Participants	55 participants n=107 Participants	2 participants n=206 Participants	484 participants n=7 Participants
Region of Enrollment Sweden	355 participants n=99 Participants	3 participants n=107 Participants	2 participants n=206 Participants	360 participants n=7 Participants
Region of Enrollment Netherlands	460 participants n=99 Participants	1 participants n=107 Participants	0 participants n=206 Participants	461 participants n=7 Participants
Region of Enrollment United Kingdom	538 participants n=99 Participants	15 participants n=107 Participants	6 participants n=206 Participants	559 participants n=7 Participants
Region of Enrollment United States	3730 participants n=99 Participants	1044 participants n=107 Participants	216 participants n=206 Participants	4990 participants n=7 Participants
Growth Hormone Deficiency (GHD) Onset Type Adult	6968 participants n=99 Participants	1422 participants n=107 Participants	247 participants n=206 Participants	8637 participants n=7 Participants
Growth Hormone Deficiency (GHD) Onset Type Childhood	1702 participants n=99 Participants	194 participants n=107 Participants	29 participants n=206 Participants	1925 participants n=7 Participants
Growth Hormone Deficiency (GHD) Onset Type Unknown	46 participants n=99 Participants	39 participants n=107 Participants	26 participants n=206 Participants	111 participants n=7 Participants
Insulin-like Growth Factor-I (IGF-I)	100.4 micrograms per liter (mcg/L) STANDARD_DEVIATION 78.0 • n=99 Participants	75.0 micrograms per liter (mcg/L) STANDARD_DEVIATION 55.3 • n=107 Participants	95.5 micrograms per liter (mcg/L) STANDARD_DEVIATION 63.7 • n=206 Participants	96.4 micrograms per liter (mcg/L) STANDARD_DEVIATION 75.2 • n=7 Participants
IGF-I Standard Deviations Score (SDS)	-2.72 standard deviation scores STANDARD_DEVIATION 2.23 • n=99 Participants	-2.82 standard deviation scores STANDARD_DEVIATION 1.97 • n=107 Participants	-2.39 standard deviation scores STANDARD_DEVIATION 2.03 • n=206 Participants	-2.73 standard deviation scores STANDARD_DEVIATION 2.19 • n=7 Participants
Maximum Growth Hormone (GH) Peak on Stimulation Test GHRH + Arginine (Arg, n=1175, 103, 51, 1329)	2.5 nanograms per milliliter (ng/mL) STANDARD_DEVIATION 3.5 • n=99 Participants	5.2 nanograms per milliliter (ng/mL) STANDARD_DEVIATION 8.1 • n=107 Participants	4.4 nanograms per milliliter (ng/mL) STANDARD_DEVIATION 8.1 • n=206 Participants	2.8 nanograms per milliliter (ng/mL) STANDARD_DEVIATION 4.4 • n=7 Participants
Maximum Growth Hormone (GH) Peak on Stimulation Test Any test except GHRH + Arg (n=6579;1178;168;7925)	1.1 nanograms per milliliter (ng/mL) STANDARD_DEVIATION 1.9 • n=99 Participants	2.0 nanograms per milliliter (ng/mL) STANDARD_DEVIATION 3.7 • n=107 Participants	5.2 nanograms per milliliter (ng/mL) STANDARD_DEVIATION 6.7 • n=206 Participants	1.3 nanograms per milliliter (ng/mL) STANDARD_DEVIATION 2.5 • n=7 Participants
Body Mass Index (BMI)	29.7 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 7.0 • n=99 Participants	29.9 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 7.0 • n=107 Participants	30.0 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 6.9 • n=206 Participants	29.7 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 7.0 • n=7 Participants
Diagnosis Leading to GHD Pituitary adenoma	3769 participants n=99 Participants	865 participants n=107 Participants	79 participants n=206 Participants	4713 participants n=7 Participants
Diagnosis Leading to GHD Craniopharyngioma	973 participants n=99 Participants	125 participants n=107 Participants	24 participants n=206 Participants	1122 participants n=7 Participants
Diagnosis Leading to GHD Other Tumor	653 participants n=99 Participants	137 participants n=107 Participants	7 participants n=206 Participants	797 participants n=7 Participants
Diagnosis Leading to GHD Idiopathic	1381 participants n=99 Participants	177 participants n=107 Participants	88 participants n=206 Participants	1646 participants n=7 Participants
Diagnosis Leading to GHD Pituitary hemorrhage/brain injury	455 participants n=99 Participants	59 participants n=107 Participants	4 participants n=206 Participants	518 participants n=7 Participants
Diagnosis Leading to GHD Other less common specified diagnoses	1027 participants n=99 Participants	198 participants n=107 Participants	79 participants n=206 Participants	1304 participants n=7 Participants
Diagnosis Leading to GHD Causes other than listed above	458 participants n=99 Participants	94 participants n=107 Participants	21 participants n=206 Participants	573 participants n=7 Participants

PRIMARY outcome

Timeframe: Baseline to study completion (approximately 10 years)

Population: All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated).

A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the Adverse Events module of this record.

Outcome measures

Outcome measures
Measure	Somatropin Treated n=8420 Participants Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.	Untreated n=1269 Participants Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.	Unknown It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
Clinically Significant Adverse Events Death	2.58 percentage of participants	3.78 percentage of participants	—
Clinically Significant Adverse Events Malignancy	4.0 percentage of participants	5.3 percentage of participants	—
Clinically Significant Adverse Events Myocardial Infarction	0.8 percentage of participants	1.4 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, interim time point (5 years), and study completion (10 years)

Population: All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and had BMI data.

Change in BMI was used as an indicator of cardiovascular risk. Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared.

Outcome measures

Outcome measures
Measure	Somatropin Treated n=8263 Participants Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.	Untreated n=1452 Participants Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.	Unknown It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
Cardiovascular Risk Factor-Change From Baseline in Body Mass Index (BMI) Change in BMI at 10 years (n=884, 64)	1.14 kilogram per square meter (kg/m^2) Standard Deviation 3.67	-0.32 kilogram per square meter (kg/m^2) Standard Deviation 2.67	—
Cardiovascular Risk Factor-Change From Baseline in Body Mass Index (BMI) Change in BMI at 5 years (n=2541, 218)	0.63 kilogram per square meter (kg/m^2) Standard Deviation 3.15	-0.10 kilogram per square meter (kg/m^2) Standard Deviation 3.25	—

SECONDARY outcome

Timeframe: Baseline, interim time point (5 years), and study completion (10 years)

Population: All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and BP data.

Change in SBP and DBP were used as an indicator of cardiovascular risk.

Outcome measures

Outcome measures
Measure	Somatropin Treated n=8258 Participants Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.	Untreated n=1546 Participants Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.	Unknown It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
Cardiovascular Risk Factor-Change From Baseline in Systolic (SBP) and Diastolic Blood Pressure (DBP) Change in SBP at 5 years (n=2746, 272)	1.04 millimeters of mercury (mmHg) Standard Deviation 17.49	-0.48 millimeters of mercury (mmHg) Standard Deviation 18.88	—
Cardiovascular Risk Factor-Change From Baseline in Systolic (SBP) and Diastolic Blood Pressure (DBP) Change in SBP at 10 years (n=960, 73)	1.98 millimeters of mercury (mmHg) Standard Deviation 18.81	3.71 millimeters of mercury (mmHg) Standard Deviation 20.04	—
Cardiovascular Risk Factor-Change From Baseline in Systolic (SBP) and Diastolic Blood Pressure (DBP) Change in DBP at 5 years (n=2740, 272)	-0.85 millimeters of mercury (mmHg) Standard Deviation 11.11	-0.76 millimeters of mercury (mmHg) Standard Deviation 11.71	—
Cardiovascular Risk Factor-Change From Baseline in Systolic (SBP) and Diastolic Blood Pressure (DBP) Change in DBP at 10 years (n=955, 73)	-1.23 millimeters of mercury (mmHg) Standard Deviation 11.85	-2.84 millimeters of mercury (mmHg) Standard Deviation 13.37	—

SECONDARY outcome

Timeframe: Baseline, interim time point (5 years), and study completion (10 years)

Population: All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and had cholesterol or triglyceride data.

Change from baseline in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides were used as an indicator of cardiovascular risk and are presented.

Outcome measures

Outcome measures
Measure	Somatropin Treated n=6327 Participants Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.	Untreated n=1171 Participants Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.	Unknown It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides Change in TC at 5 years (n=1865, 184)	-13.0 milligrams per deciliter (mg/dL) Standard Deviation 45.74	-14.6 milligrams per deciliter (mg/dL) Standard Deviation 46.02	—
Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides Change in TC at 10 years (n=668, 56)	-17.9 milligrams per deciliter (mg/dL) Standard Deviation 52.87	-43.1 milligrams per deciliter (mg/dL) Standard Deviation 55.81	—
Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides Change in HDL-C at 5 years (n=1667, 176)	1.47 milligrams per deciliter (mg/dL) Standard Deviation 16.67	-0.54 milligrams per deciliter (mg/dL) Standard Deviation 13.82	—
Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides Change in HDL-C at 10 years (n=615, 51)	5.00 milligrams per deciliter (mg/dL) Standard Deviation 17.40	0.39 milligrams per deciliter (mg/dL) Standard Deviation 14.70	—
Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides Change in LDL-C at 5 years (1435, 166)	-10.7 milligrams per deciliter (mg/dL) Standard Deviation 41.32	-11.5 milligrams per deciliter (mg/dL) Standard Deviation 35.91	—
Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides Change in LDL-C at 10 years (n=522, 47)	-16.4 milligrams per deciliter (mg/dL) Standard Deviation 44.05	-29.3 milligrams per deciliter (mg/dL) Standard Deviation 41.44	—
Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides Change in Triglycerides at 5 years (n=1581, 178)	-9.51 milligrams per deciliter (mg/dL) Standard Deviation 99.67	-0.85 milligrams per deciliter (mg/dL) Standard Deviation 115.7	—
Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides Change in Triglycerides at 10 years (n=571, 51)	-16.4 milligrams per deciliter (mg/dL) Standard Deviation 107.8	-55.8 milligrams per deciliter (mg/dL) Standard Deviation 90.12	—

SECONDARY outcome

Timeframe: Baseline, interim time point (5 years), and study completion (10 years)

Population: All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and had waste circumference data.

Change in waist circumference was used as an indicator of cardiovascular risk.

Outcome measures

Outcome measures
Measure	Somatropin Treated n=6263 Participants Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.	Untreated n=1005 Participants Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.	Unknown It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
Cardiovascular Risk Factor-Change From Baseline in Waist Circumference Change in circumference at 5 years (n=1719, 133)	0.85 centimeters (cm) Standard Deviation 9.06	0.10 centimeters (cm) Standard Deviation 8.52	—
Cardiovascular Risk Factor-Change From Baseline in Waist Circumference Change in circumference at 10 years (n=610, 34)	3.57 centimeters (cm) Standard Deviation 10.22	3.03 centimeters (cm) Standard Deviation 7.76	—

SECONDARY outcome

Timeframe: Baseline through 10 years

Population: All participants with baseline and at least 1 post-baseline visit and who provided bone fracture information.

Outcome measures

Outcome measures
Measure	Somatropin Treated n=8420 Participants Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.	Untreated n=1269 Participants Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.	Unknown n=4 Participants It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
Percentage of Participants Experiencing a Bone Fracture (Fracture Incidence)	3.75 percentage of participants	4.02 percentage of participants	0.00 percentage of participants

SECONDARY outcome

Timeframe: Baseline, interim time point (5 years), and study completion (10 years)

Population: All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and has a Total Z Score.

QLS-H is a self-administered, weighted, quality of life (QoL) questionnaire consisting of 9 items developed for participants with growth hormone deficiency. Scores were corrected for age, gender, and country differences, and expressed as Z-scores based on country-specific reference ranges. Participants indicate how important a certain dimension of QoL is to them and are then questioned as to their degree of satisfaction with that dimension. Each item is rated on a 5-point Likert scale ranging from not important (1) to extremely important (5) and from dissatisfied (1) to very satisfied (5). The weighted score for the degree of satisfaction (weighted satisfaction) with a particular dimension=(importance - 1)x(2 x satisfaction - 5). Total Z-score is obtained by adding the individual item scores of the 9 dimensions, and range from -108 (representing very low satisfaction) to +180 (representing very high satisfaction).

Outcome measures

Outcome measures
Measure	Somatropin Treated n=2142 Participants Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.	Untreated n=332 Participants Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.	Unknown It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
Change From Baseline in the Total Z Score of the Disease-specific Module of the Questions of Life Satisfaction (QLS-H). Change in Total Z score at 5 years (n=475, 39)	0.70 Z-score Standard Deviation 1.46	0.21 Z-score Standard Deviation 1.14	—
Change From Baseline in the Total Z Score of the Disease-specific Module of the Questions of Life Satisfaction (QLS-H). Change in Total Z score at 10 years (n=103, 3)	0.53 Z-score Standard Deviation 1.39	-1.01 Z-score Standard Deviation 1.49	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Study enrollment up to approximately 10 years

Population: All participants with baseline and at least 1 post-baseline visit.

Outcome measures

Outcome measures
Measure	Somatropin Treated n=8420 Participants Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.	Untreated n=1269 Participants Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.	Unknown n=4 Participants It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
Number of Participants Who Died While in the Study	229 participants	50 participants	0 participants

Adverse Events

Somatropin Treated

Serious events: 1602 serious events

Other events: 4912 other events

Deaths: 0 deaths

Untreated

Serious events: 288 serious events

Other events: 591 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Somatropin Treated n=8420 participants at risk Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.	Untreated n=1269 participants at risk Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.	n=4 participants at risk It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
Gastrointestinal disorders Diarrhoea	2.0% 165/8420 • Number of events 202 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	2.7% 34/1269 • Number of events 41 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.0% 167/8420 • Number of events 169 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	2.0% 26/1269 • Number of events 26 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Gastrointestinal disorders Nausea	2.5% 213/8420 • Number of events 242 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	1.9% 24/1269 • Number of events 29 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
General disorders Asthenia	2.4% 206/8420 • Number of events 216 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	2.8% 36/1269 • Number of events 42 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
General disorders Fatigue	5.9% 495/8420 • Number of events 524 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	5.9% 75/1269 • Number of events 76 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
General disorders Oedema peripheral	6.5% 546/8420 • Number of events 624 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	2.1% 27/1269 • Number of events 31 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Infections and infestations Influenza	2.4% 198/8420 • Number of events 216 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	1.0% 13/1269 • Number of events 14 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Infections and infestations Nasopharyngitis	2.1% 176/8420 • Number of events 211 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	1.3% 16/1269 • Number of events 16 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Infections and infestations Sinusitis	2.9% 242/8420 • Number of events 322 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	1.7% 22/1269 • Number of events 24 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Infections and infestations Upper respiratory tract infection	2.2% 185/8420 • Number of events 234 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	2.2% 28/1269 • Number of events 34 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Investigations Weight increased	2.2% 185/8420 • Number of events 192 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	1.7% 21/1269 • Number of events 21 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Metabolism and nutrition disorders Diabetes mellitus	2.3% 194/8420 • Number of events 209 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	1.9% 24/1269 • Number of events 24 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Metabolism and nutrition disorders Hyperlipidaemia	3.1% 263/8420 • Number of events 268 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	2.9% 37/1269 • Number of events 37 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Metabolism and nutrition disorders Vitamin d deficiency	1.7% 144/8420 • Number of events 145 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	3.1% 39/1269 • Number of events 39 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Musculoskeletal and connective tissue disorders Arthralgia	8.8% 742/8420 • Number of events 887 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	3.8% 48/1269 • Number of events 54 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Musculoskeletal and connective tissue disorders Back pain	4.1% 347/8420 • Number of events 384 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	2.6% 33/1269 • Number of events 35 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Musculoskeletal and connective tissue disorders Myalgia	2.8% 236/8420 • Number of events 252 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.95% 12/1269 • Number of events 12 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Musculoskeletal and connective tissue disorders Osteopenia	2.2% 184/8420 • Number of events 185 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	2.8% 35/1269 • Number of events 35 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Musculoskeletal and connective tissue disorders Osteoporosis	1.9% 164/8420 • Number of events 165 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	3.2% 41/1269 • Number of events 41 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Musculoskeletal and connective tissue disorders Pain in extremity	3.3% 276/8420 • Number of events 315 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	2.4% 30/1269 • Number of events 38 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Nervous system disorders Carpal tunnel syndrome	2.1% 181/8420 • Number of events 196 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.79% 10/1269 • Number of events 11 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Nervous system disorders Dizziness	2.6% 220/8420 • Number of events 238 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	3.2% 40/1269 • Number of events 44 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Nervous system disorders Headache	6.3% 533/8420 • Number of events 607 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	4.5% 57/1269 • Number of events 66 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Nervous system disorders Paraesthesia	2.5% 210/8420 • Number of events 233 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.32% 4/1269 • Number of events 4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Psychiatric disorders Depression	6.6% 557/8420 • Number of events 590 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	4.3% 54/1269 • Number of events 56 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Psychiatric disorders Insomnia	2.2% 185/8420 • Number of events 192 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	1.7% 22/1269 • Number of events 22 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Reproductive system and breast disorders Erectile dysfunction	1.7% 74/4394 • Number of events 76 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	2.1% 16/745 • Number of events 16 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/2 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	2.2% 182/8420 • Number of events 184 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	1.6% 20/1269 • Number of events 20 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.
Vascular disorders Hypertension	7.5% 630/8420 • Number of events 671 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	4.6% 59/1269 • Number of events 61 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.	0.00% 0/4 • Study enrollment up to approximately 10 years. All participants with baseline and at least 1 post-baseline visit.