Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| #817 B9R-CA-GDCT Core study | |||
| #4419 GDCT/1 Addenda |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin) treatment in promoting linear growth to final height.
A randomized, controlled trial of Humatrope (somatropin) treatment in girls with Turner syndrome at least 7 years old and younger than 13 at study entry.
Core study objectives are to determine the efficacy of Humatrope in promoting linear growth to final height in girls with Turner syndrome, and to assess the safety of this treatment. Core study completion criteria (protocol final height) are that the patient has both a height velocity < 2 cm per year and a bone age of 14 years or greater.
Addendum 1 provides the option of Humatrope treatment to patients who were randomized to the Control arm of the Core study and who discontinued from the study on or after December 19, 1997.
Addendum 2 objectives are: 1) to collect true final height data; 2) to evaluate hearing, tympanic membrane function and other specific areas of interest with respect to the safety of growth hormone therapy in Turner syndrome; 3) to evaluate pancreatic beta cell function (glucose metabolism) in patients previously enrolled in the Core study.
Addendum 3 objective is to determine the parental origin of the retained X chromosome of an appropriate subset of patients currently or previously enrolled in the Core study, and to determine whether this parental origin holds any predictive value for spontaneous growth or for response to growth hormone therapy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height). |
|
| Humatrope | Experimental | Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatropin | Drug | 0.05 mg/kg/dose by subcutaneous injection 6 times per week, until Core study completion criteria are met (protocol final height). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population | Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height. | Baseline, and end of 4-year addendum |
| Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height | SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS [NCHS] uses the NCHS US general female population reference height values for age (Kuczmarski RJ et al. 2000) as the population mean and standard deviation. Calculation of Height SDS is provided in Height SDS [Lyon] description (Baseline). Since data reported by Kuczmarski RJ et al provides US general female population standards, values of Height SDS [NCHS] for untreated patients with Turner syndrome tend to be below zero e.g, -2.0 to -4.0 SDS. | at completion of core study, or at end of 4-year addendum |
| Measure | Description | Time Frame |
|---|---|---|
| Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population | Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Calgary | Alberta | T2T 5C7 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 4062345 | Background | Lyon AJ, Preece MA, Grant DB. Growth curve for girls with Turner syndrome. Arch Dis Child. 1985 Oct;60(10):932-5. doi: 10.1136/adc.60.10.932. | |
| 11183293 | Background | Kuczmarski RJ, Ogden CL, Grummer-Strawn LM, Flegal KM, Guo SS, Wei R, Mei Z, Curtin LR, Roche AF, Johnson CL. CDC growth charts: United States. Adv Data. 2000 Jun 8;(314):1-27. |
Not provided
Not provided
Addendum 1: provided option of Humatrope treatment to patients who had been randomized to control in Core Study. Addendum 2: extended period of follow-up for 5 years after discontinuation from Core Study. Addendum 3: evaluated possible genomic imprinting effects (published: Hamelin et al. 2006).
Addenda 1, 2, and 3 are not sequential, and they differ in eligibility criteria. Depending on individual eligibility and choices made, a patient might have participated in none, 1, 2, or all 3 of these addenda.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | As-Randomized Control | Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height). |
| FG001 | As-Randomized Humatrope | Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Core Study |
|
| |||||||||||||||||||||
| Addendum 1 |
| ||||||||||||||||||||||
| Addendum 2 |
| ||||||||||||||||||||||
| Addendum 3 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | As-Randomized Control | Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population | Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height. | Population of all randomized patients. Intent to treat analysis with as-randomized treatment groups, at most mature measurement available. | Posted | Least Squares Mean | Standard Error | Standard Deviation Score (SDS) [NCHS] | Baseline, and end of 4-year addendum |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treated-As-Randomized Control | Patients in the As-Randomized Control group who at each observed time point remained untreated with growth hormone. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia iron deficiency | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear ache | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D014424 | Turner Syndrome |
| D013577 | Syndrome |
| D004392 | Dwarfism |
| ID | Term |
|---|---|
| D006059 | Gonadal Dysgenesis |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| D013006 | Growth Hormone |
| D004997 | Ethinyl Estradiol |
| D017258 | Medroxyprogesterone Acetate |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ethinyl estradiol | Drug | escalating doses 2.5-20.0 mcg tablets daily after age 13 and at least one year on study, continuing until Core study completion criteria are met. |
|
| Medroxyprogesterone acetate | Drug | 10 mg tablets, ten days monthly, after age 15, continuing until Core study completion criteria are met. |
|
| every 3 months during core study, and at start and end of 4-year addendum |
| Height (Centimeters [cm]) | Most mature measurement available, at or after attainment of Final Height. | every 3 months during core study, and at start and end of 4-year addendum |
| Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment | at completion of core study or beginning of addendum |
| Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment | at completion of core study or beginning of addendum |
| Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment | at completion of core study or beginning of addendum |
| Number of Participants With Hearing Loss, Audiologist Assessment | Sensorineural Hearing Loss (SNHL)=air conduction threshold >20 dB HL and air-bone gap ≤10 dB HL; Conductive Hearing Loss (CHL)= air conduction threshold >20 dB HL, bone conduction threshold ≤20 dB HL and air-bone gap >10 dB HL; Mixed Hearing Loss (MHL) = evidence of SNHL as defined above and CHL as defined above, in the same ear; Unspecified Hearing Loss (UHL)= abnormal hearing with none of SNHL, CHL, or MHL present. | at completion of core study or beginning of addendum |
| Fasting Glucose, Change From Baseline | Change from core study baseline to addendum 2 maximum. | At core study baseline, and at end of 4-year addendum |
| Maximum Fasting Glucose Value | Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years. | At start and through end of 4-year addendum (up to an additional 2 years) |
| Number of Participants With Any Abnormal Fasting Glucose Value | Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Glucose=Fasting Glucose >=100 milligrams per deciliter (mg/dL). | At start and through end of 4-year addendum |
| Maximum Fasting Insulin Values | Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years. | At start and through end of 4-year addendum (up to an additional 2 years) |
| Number of Participants With Any Abnormal Fasting Insulin Value | Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Insulin = Fasting Insulin >=35 micro International Units per milliliter (uIU/mL). | At start and through end of 4-year addendum |
| Minimum Fasting Glucose/Insulin Ratio Values | Minimum measured value over addendum. In special cases an additional measurement is taken at 2 years. | At start and through end of 4-year addendum (up to an additional 2 years) |
| Number of Participants With Any Abnormal Fasting Glucose/Insulin Ratio Value | Indicates if patient had any measured value below threshold of normality at any visit during addendum. Abnormal Fasting Glucose/Insulin Ratio = Fasting Glucose/Insulin Ratio <=4.5 milligrams per 10^-4 Units (mg/10^-4U). | At start and through end of 4-year addendum |
| Glycosylated Hemoglobin, Change From Baseline | Change from core study baseline to addendum 2 maximum. | At core study baseline, and at end of 4-year addendum |
| Maximum Glycosylated Hemoglobin | Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years. | At start and through end of 4-year addendum (up to an additional 2 years) |
| Number of Participants With Any Abnormal Glycosylated Hemoglobin (HbA1c) Value | Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Glycosylated Hemoglobin = HbA1c ≥6.8% (up until 11-May-1998); and then HbA1c ≥6.1% (from 19-May-1998 onwards). | At start and through end of 4-year addendum |
| Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Edmonton | Alberta | T6G 2B7 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vancouver | British Columbia | V6H 3V4 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Winnipeg | Manitoba | R3E 0Z2 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Halifax | Nova Scotia | B3J 3G9 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hamilton | Ontario | L8S 3Z5 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kingston | Ontario | K7L 3N6 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | London | Ontario | K7L 3N6 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ottawa | Ontario | K1H 8L1 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Toronto | Ontario | M5G 1X8 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Montreal | Quebec | H3H 1P3 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Montreal | Quebec | H3T 1C5 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sainte-Foy | Quebec | G1V 4G2 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sherbrooke | Quebec | J1G 2E8 | Canada |
| 16757526 | Result | Hamelin CE, Anglin G, Quigley CA, Deal CL. Genomic imprinting in Turner syndrome: effects on response to growth hormone and on risk of sensorineural hearing loss. J Clin Endocrinol Metab. 2006 Aug;91(8):3002-10. doi: 10.1210/jc.2006-0490. Epub 2006 Jun 6. |
| 15784709 | Result | Stephure DK; Canadian Growth Hormone Advisory Committee. Impact of growth hormone supplementation on adult height in turner syndrome: results of the Canadian randomized controlled trial. J Clin Endocrinol Metab. 2005 Jun;90(6):3360-6. doi: 10.1210/jc.2004-2187. Epub 2005 Mar 22. |
| 21619701 | Derived | Taback SP, Van Vliet G. Health-related quality of life of young adults with Turner syndrome following a long-term randomized controlled trial of recombinant human growth hormone. BMC Pediatr. 2011 May 29;11:49. doi: 10.1186/1471-2431-11-49. |
| Lost to Follow-up |
|
| Adverse Event |
|
| Lack of Efficacy |
|
| Death |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| As-Randomized Humatrope |
Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Karyotype | Number | participants |
|
| Race/Ethnicity | Number | participants |
|
| Bone Age | Bone age was determined by the Greulich-Pyle method. | Mean | Standard Deviation | years |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Height Standard Deviation Score (SDS) [Lyon] | SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS [Lyon] uses the Turner syndrome reference height values for age (Lyon AJ et al. 1985) as the population mean and standard deviation. Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Since the data reported by Lyon AJ et al represent a Turner syndrome reference standard, values for patients with Turner syndrome are centered around zero. | Mean | Standard Deviation | Standard Deviation Score (SDS) |
|
| Height Standard Deviation Score (SDS) [National Center for Health Statistics (NCHS)] | SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS [NCHS] uses the NCHS US general female population reference height values for age (Kuczmarski RJ et al. 2000) as the population mean and standard deviation. Calculation of Height SDS is provided in Height SDS [Lyon] description (baseline). Since data reported by Kuczmarski RJ et al provides US general female population standards, values of Height SDS [NCHS] for untreated patients with Turner syndrome tend to be below zero e.g, -2.0 to -4.0 SDS. | Mean | Standard Deviation | Standard Deviation Score (SDS) |
|
| OG001 | As-Randomized Humatrope | Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height). |
|
|
|
| Primary | Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height | SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS [NCHS] uses the NCHS US general female population reference height values for age (Kuczmarski RJ et al. 2000) as the population mean and standard deviation. Calculation of Height SDS is provided in Height SDS [Lyon] description (Baseline). Since data reported by Kuczmarski RJ et al provides US general female population standards, values of Height SDS [NCHS] for untreated patients with Turner syndrome tend to be below zero e.g, -2.0 to -4.0 SDS. | Population of patients for whom Final Height measurements are available. Efficacy analysis with as-treated treatment groups, at most mature measurement available at or after attainment of Final Height. | Posted | Least Squares Mean | Standard Error | Standard Deviation Score (SDS) [NCHS] | at completion of core study, or at end of 4-year addendum |
|
|
|
|
| Secondary | Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population | Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height. | Posted | Least Squares Mean | Standard Error | Standard Deviation Score (SDS) [NCHS] | every 3 months during core study, and at start and end of 4-year addendum |
|
|
|
|
| Secondary | Height (Centimeters [cm]) | Most mature measurement available, at or after attainment of Final Height. | Posted | Least Squares Mean | Standard Error | centimeters (cm) | every 3 months during core study, and at start and end of 4-year addendum |
|
|
|
|
| Secondary | Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment | All Randomized Patients with Hearing Examination | Posted | Number | participants | at completion of core study or beginning of addendum |
|
|
|
|
| Secondary | Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment | All Randomized Patients with Hearing Examination | Posted | Number | participants | at completion of core study or beginning of addendum |
|
|
|
|
| Secondary | Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment | All Randomized Patients with Hearing Examination | Posted | Number | participants | at completion of core study or beginning of addendum |
|
|
|
|
| Secondary | Number of Participants With Hearing Loss, Audiologist Assessment | Sensorineural Hearing Loss (SNHL)=air conduction threshold >20 dB HL and air-bone gap ≤10 dB HL; Conductive Hearing Loss (CHL)= air conduction threshold >20 dB HL, bone conduction threshold ≤20 dB HL and air-bone gap >10 dB HL; Mixed Hearing Loss (MHL) = evidence of SNHL as defined above and CHL as defined above, in the same ear; Unspecified Hearing Loss (UHL)= abnormal hearing with none of SNHL, CHL, or MHL present. | All Randomized Patients with Hearing Examination for whom Audiologist responded to Hearing Loss question | Posted | Number | participants | at completion of core study or beginning of addendum |
|
|
|
|
| Secondary | Fasting Glucose, Change From Baseline | Change from core study baseline to addendum 2 maximum. | Patients who were followed for at least 4 years without growth hormone treatment or who received growth hormone for at least 4 years, and who were treated as randomized and had core study baseline and addendum glucose metabolism data. | Posted | Least Squares Mean | Standard Error | mg / dL | At core study baseline, and at end of 4-year addendum |
|
|
|
|
| Secondary | Maximum Fasting Glucose Value | Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years. | Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | At start and through end of 4-year addendum (up to an additional 2 years) |
|
|
|
| Secondary | Number of Participants With Any Abnormal Fasting Glucose Value | Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Glucose=Fasting Glucose >=100 milligrams per deciliter (mg/dL). | Patients with any Addendum 2 glucose metabolism data | Posted | Number | participants | At start and through end of 4-year addendum |
|
|
|
|
| Secondary | Maximum Fasting Insulin Values | Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years. | Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years. | Posted | Mean | Standard Deviation | micro International Units per milliliter | At start and through end of 4-year addendum (up to an additional 2 years) |
|
|
|
| Secondary | Number of Participants With Any Abnormal Fasting Insulin Value | Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Insulin = Fasting Insulin >=35 micro International Units per milliliter (uIU/mL). | Patients with any Addendum 2 glucose metabolism data | Posted | Number | participants | At start and through end of 4-year addendum |
|
|
|
|
| Secondary | Minimum Fasting Glucose/Insulin Ratio Values | Minimum measured value over addendum. In special cases an additional measurement is taken at 2 years. | Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years. | Posted | Mean | Standard Deviation | milligrams per 10^-4 Units (mg/[10^-4]U) | At start and through end of 4-year addendum (up to an additional 2 years) |
|
|
|
| Secondary | Number of Participants With Any Abnormal Fasting Glucose/Insulin Ratio Value | Indicates if patient had any measured value below threshold of normality at any visit during addendum. Abnormal Fasting Glucose/Insulin Ratio = Fasting Glucose/Insulin Ratio <=4.5 milligrams per 10^-4 Units (mg/10^-4U). | Patients with any Addendum 2 glucose metabolism data. Calculated only for patients with fasting blood <100 mg/dL. | Posted | Number | participants | At start and through end of 4-year addendum |
|
|
|
|
| Secondary | Glycosylated Hemoglobin, Change From Baseline | Change from core study baseline to addendum 2 maximum. | Patients who were followed for at least 4 years without growth hormone treatment or who received growth hormone for at least 4 years, and who were treated as randomized and had core study baseline and addendum glucose metabolism data. | Posted | Least Squares Mean | Standard Error | percent (%) | At core study baseline, and at end of 4-year addendum |
|
|
|
|
| Secondary | Maximum Glycosylated Hemoglobin | Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years. | Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years. | Posted | Mean | Standard Deviation | percent (%) | At start and through end of 4-year addendum (up to an additional 2 years) |
|
|
|
| Secondary | Number of Participants With Any Abnormal Glycosylated Hemoglobin (HbA1c) Value | Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Glycosylated Hemoglobin = HbA1c ≥6.8% (up until 11-May-1998); and then HbA1c ≥6.1% (from 19-May-1998 onwards). | Patients with any Addendum 2 glucose metabolism data. | Posted | Number | participants | At start and through end of 4-year addendum |
|
|
|
|
| 10 |
| 54 |
| 53 |
| 54 |
| EG001 | Treated-As-Randomized Humatrope | Patients in the As-Randomized Humatrope group who received Humatrope | 22 | 74 | 74 | 74 |
| Hypochromic microcytic anemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cellulitis of foot | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Stomach flu | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Viral meningitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Arm fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Colonoscopy | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Cystoscopy | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Brain neoplasm benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Adenoidectomy | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Aorta coarctation repair | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Appendectomy | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Chest wall repair | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Cholesteatoma removal | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Dental surgery NOS | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Eye muscle operation | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Heart valve operation | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Mastoid operation | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Mastoidectomy | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Orchiectomy | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Pterygium operation | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Scar removal | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Surgical procedure | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Tympanoplasty | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Ear discharge | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| Earache | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hearing loss | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sensorineural hearing loss | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| Tympanosclerosis | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 11.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| Myopia | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Ache stomach | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Stomach ache | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Stomach cramps | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Upset stomach | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Fever | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hay fever | Immune system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Multiple allergies | Immune system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Bladder infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Chest cold | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Chickenpox | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Cold | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Cold symptoms | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Common cold | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Flu | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Flu syndrome | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Head cold | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Sinus infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Stomach flu | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Streptococcal sore throat | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Throat infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Knee pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Leg pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Low back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Intermittent headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cramps menstrual | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| Menstrual cramps | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| Primary ovarian failure | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| Spotting vaginal | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Congestion nasal | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Coughing | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nasal discharge | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nose bleed | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Throat sore | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Ingrown toe nail | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dental surgery NOS | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Dental treatment | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Ear tube insertion | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Mole excision | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Myringotomy | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Tympanoplasty | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Aortic dilatation | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Blood pressure high | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D058533 | Sex Chromosome Disorders of Sex Development |
| D052801 | Male Urogenital Diseases |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025064 | Sex Chromosome Disorders |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D004194 | Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D008525 | Medroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| Mixed Hearing Loss |
|
| Unspecified Hearing Loss |
|