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| ID | Type | Description | Link |
|---|---|---|---|
| B9R-US-GDGH | Other Identifier | Eli Lilly and Company |
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This is an extension study that will gather long-term data on the effect of early growth hormone (GH) treatment on adult height and other aspects of health and development in girls with Turner syndrome. The main purpose is to determine whether girls who received 2 years of GH treatment before 6 years of age achieve taller adult height than girls who were untreated during this time. The study will also look at middle ear and hearing function, and cognitive and behavioral development. Protocol completion is defined as attainment of height velocity less than or equal to 1.0 cm/year, or bone age greater than or equal to 15 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1 Control | Experimental | No drug administration in B9R-US-GDFG (NCT00406926). Humatrope according to investigator's clinical practice and guided by the approved package insert on whether treatment is given. |
|
| Experimental 2 Humatrope | Experimental | Humatrope according to investigator's clinical practice and guided by the approved package insert on whether treatment is given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Humatrope | Drug | According to investigator's clinical practice and guided by the approved package insert |
|
| Measure | Description | Time Frame |
|---|---|---|
| Most Mature Height Standard Deviation Score (SDS) | SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height. | Baseline through End of Study (10 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Height SDS at Various Ages | SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height. | Age 10, Age 13, Age 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 hrs) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital of Los Angeles | Los Angeles | California | 90027 | United States | ||
| Children's Hospital |
Not provided
To be included in this study, participants had to be females with karyotype-proven Turner syndrome who were previously randomized in Study B9R-US-GDFG (NCT00406926).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Early Treated | Humatrope administered according to investigator's clinical practice and guided by the approved package insert. Humatrope administered in B9R-US-GDFG (NCT00406926). |
| FG001 | Early Untreated | Humatrope administered according to investigator's clinical practice and guided by the approved package insert. Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled/started participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Early Treated | Early treated n=36 |
| BG001 | Early Untreated | Early untreated n=33 |
| 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 | Most Mature Height Standard Deviation Score (SDS) | SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height. | All participants who achieved Near Adult Height (NAH). NAH is defined as first height measured when height velocity is less than or equal to 2.0 centimeter per year over the preceding year (in the absence of growth-impairing process such as hypothyroidism or inflammatory bowel disease), or bone age greater than or equal to14.5 years. | Posted | Mean | Standard Deviation | standard deviation score | Baseline through End of Study (10 years) |
|
Not provided
All enrolled/started participants.
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 | Early Treated | Humatrope administered according to investigator's clinical practice and guided by the approved package insert. Humatrope administered in B9R-US-GDFG (NCT00406926). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anomalous pulmonary venous connection | Congenital, familial and genetic disorders | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D014424 | Turner Syndrome |
| 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 |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| Age at Attainment of Tanner 2 Breast Development | The Tanner 2 breast development is the age at first evidence of breast development. | Baseline through End of Study (10 years) |
| Chronological Age at First Visit Participant Attained Bone Age of 14.5 Years | Bone age was measured by standard radiograph, x-ray at baseline and annually for 10 years or until attainment of height velocity less than or equal to 1.0 centimeter per year (cm/year) and bone age greater or equal to 15 years. | Baseline through End of Study (10 years) |
| Reports of Serious Adverse Events | Number of serious adverse events (SAEs) reported. Any adverse event from this study that results in one of the following outcomes, or is significant for any other reason were reported as an SAE: death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a study subject, significant for any other reason (includes cancer, other than superficial, and basal cell or squamous cell carcinomas of the skin, that did not meet other serious adverse event criteria). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. | Baseline through End of Study (10 years) |
| Percentage of Participants With Occurrence of Pre-specified Clinically Relevant Events | Percentage of participants for whom certain non-serious, pre-specified adverse events (AEs; those that are commonly observed in Turner syndrome or are known to be related to GH treatment: impaired glucose tolerance, diabetes mellitus, hypothyroidism, benign intracranial hypertension, scoliosis, slipped capital femoral epiphysis, solid tumor/leukemia, pancreatitis, ear infections, and high blood pressure) are reported. | Baseline through End of Study (10 years) |
| Percentage of Participants With Abnormal Tympanometry Results | Percentage of participants with abnormal tympanometry [defined as middle ear dysfunction / middle ear effusion / patent pressure equalizer tube or possible tympanic membrane perforation] results at baseline, age 10 years, and age 16 years or endpoint. | Baseline, Age 10, Age 16, End of Study (10 years) |
| Percentage of Participants With Prevalence of Abnormal Audiometry Results | Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. Prevalence was calculated as number of participants with abnormal hearing divided by number of participants with measurable pure tone audiometry results at that visit. | Baseline, Age 10, Age 16, End of Study (10 years) |
| Percentage of Participants With Abnormal Audiometry Results Based on Pure Tone Average (PTA) | Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. PTA is defined as the average of pure tone hearing thresholds at 500, 1000 and 2000 Hz (Hertz), calculated separately for each ear and for each testing method (air or bone); normal PTA is defined as pure tone hearing threshold less than or equal to 20 dB HL (decibels Hearing Level), and abnormal PTA is defined as pure tone hearing threshold greater than 20 DB HL. | Baseline, Age 10, Age 16, End of Study (10 years) |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| Children's Hospital of Chicago Research Center | Chicago | Illinois | 60611 | United States |
| Riley Hosptial for Children | Indianapolis | Indiana | 46202 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| University of NC at Chapel Hill School of Medicine | Chapel Hill | North Carolina | 27514 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Childrens Hospital and Medical Center | Seattle | Washington | 98105 | United States |
| Withdrawal by Subject |
|
| Did Not Reach Final Height |
|
| Parent/Caregiver Decision |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeter |
|
| Height Standard Deviation Score (SDS) | Mean | Standard Deviation | Standard Deviation Score |
|
| Bone Age | Mean | Standard Deviation | years |
|
| OG001 | Early Untreated | Humatrope administered according to investigator's clinical practice and guided by the approved package insert. Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926). |
|
|
| Secondary | Height SDS at Various Ages | SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height. | All participants who had a baseline visit and at least one post-baseline visit. | Posted | Mean | Standard Deviation | Standard deviation score | Age 10, Age 13, Age 16 |
|
|
|
| Secondary | Age at Attainment of Tanner 2 Breast Development | The Tanner 2 breast development is the age at first evidence of breast development. | All participants who had a baseline visit and at least one post-baseline visit. | Posted | Mean | Standard Error | years | Baseline through End of Study (10 years) |
|
|
|
| Secondary | Chronological Age at First Visit Participant Attained Bone Age of 14.5 Years | Bone age was measured by standard radiograph, x-ray at baseline and annually for 10 years or until attainment of height velocity less than or equal to 1.0 centimeter per year (cm/year) and bone age greater or equal to 15 years. | All participants who achieved Near Adult Height (NAH). NAH is defined as first height measured when height velocity is less than or equal to 2.0 centimeter per year over the preceding year (in the absence of growth-impairing process such as hypothyroidism or inflammatory bowel disease), or bone age greater than or equal to14.5 years. | Posted | Mean | Standard Error | years | Baseline through End of Study (10 years) |
|
|
|
| Secondary | Reports of Serious Adverse Events | Number of serious adverse events (SAEs) reported. Any adverse event from this study that results in one of the following outcomes, or is significant for any other reason were reported as an SAE: death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a study subject, significant for any other reason (includes cancer, other than superficial, and basal cell or squamous cell carcinomas of the skin, that did not meet other serious adverse event criteria). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. | All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time. | Posted | Number | events | Baseline through End of Study (10 years) |
|
|
|
| Secondary | Percentage of Participants With Occurrence of Pre-specified Clinically Relevant Events | Percentage of participants for whom certain non-serious, pre-specified adverse events (AEs; those that are commonly observed in Turner syndrome or are known to be related to GH treatment: impaired glucose tolerance, diabetes mellitus, hypothyroidism, benign intracranial hypertension, scoliosis, slipped capital femoral epiphysis, solid tumor/leukemia, pancreatitis, ear infections, and high blood pressure) are reported. | All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time. | Posted | Number | percentage of participants | Baseline through End of Study (10 years) |
|
|
|
| Secondary | Percentage of Participants With Abnormal Tympanometry Results | Percentage of participants with abnormal tympanometry [defined as middle ear dysfunction / middle ear effusion / patent pressure equalizer tube or possible tympanic membrane perforation] results at baseline, age 10 years, and age 16 years or endpoint. | All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time. | Posted | Number | percentage of participants | Baseline, Age 10, Age 16, End of Study (10 years) |
|
|
|
| Secondary | Percentage of Participants With Prevalence of Abnormal Audiometry Results | Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. Prevalence was calculated as number of participants with abnormal hearing divided by number of participants with measurable pure tone audiometry results at that visit. | All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time. | Posted | Number | percentage of participants | Baseline, Age 10, Age 16, End of Study (10 years) |
|
|
|
| Secondary | Percentage of Participants With Abnormal Audiometry Results Based on Pure Tone Average (PTA) | Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. PTA is defined as the average of pure tone hearing thresholds at 500, 1000 and 2000 Hz (Hertz), calculated separately for each ear and for each testing method (air or bone); normal PTA is defined as pure tone hearing threshold less than or equal to 20 dB HL (decibels Hearing Level), and abnormal PTA is defined as pure tone hearing threshold greater than 20 DB HL. | All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time. | Posted | Number | percentage of participants | Baseline, Age 10, Age 16, End of Study (10 years) |
|
|
|
| 6 |
| 36 |
| 34 |
| 36 |
| EG001 | Early Untreated | Humatrope administered according to investigator's clinical practice and guided by the approved package insert. Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926). | 5 | 33 | 32 | 33 |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pterygium colli | Congenital, familial and genetic disorders | MedDRA 18.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Medulloblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Mediastinal mass | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Conductive deafness | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
|
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
|
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 18.0 | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 18.0 | Systematic Assessment |
|
| Myopia | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Coeliac disease | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Tooth malformation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Multiple allergies | Immune system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Croup infectious | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Mononucleosis syndrome | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Echocardiogram normal | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Electrocardiogram normal | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Ultrasound kidney normal | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Ultrasound scan normal | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Kyphosis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Obsessive-compulsive disorder | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Enuresis | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Keloid scar | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Seborrhoea | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Corrective lens user | Social circumstances | MedDRA 18.0 | Systematic Assessment |
|
| Orthodontic appliance user | Social circumstances | MedDRA 18.0 | Systematic Assessment |
|
| Adenoidectomy | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
|
| Ear tube insertion | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
|
| Mole excision | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
|
| Oral surgery | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
|
| Orthodontic procedure | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
|
| Palatal operation | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
|
| Tympanoplasty | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
|
| Wisdom teeth removal | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
|
| Aortic dilatation | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 18.0 | 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 |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Age 16 (n=18, 18) |
|
| Baseline Hypothyroidism |
|
| Baseline Scoliosis |
|
| Year 1 Ear infections |
|
| Year 1 High Blood Pressure |
|
| Year 1 Hypothyroidism |
|
| Year 1 Scoliosis |
|
| Year 2 Diabetes |
|
| Year 2 Dilatation of the Aorta |
|
| Year 2 Ear infections |
|
| Year 2 High Blood Pressure |
|
| Year 2 Hypothyroidism |
|
| Year 2 Scoliosis |
|
| Year 3 Diabetes |
|
| Year 3 Dilatation of the Aorta |
|
| Year 3 Ear infections |
|
| Year 3 High Blood Pressure |
|
| Year 3 Hypothyroidism |
|
| Year 3 Scoliosis |
|
| Year 4 Diabetes |
|
| Year 4 Dilatation of the Aorta |
|
| Year 4 Ear infections |
|
| Year 4 High Blood Pressure |
|
| Year 4 Hypothyroidism |
|
| Year 4 Scoliosis |
|
| Year 5 Diabetes |
|
| Year 5 Dilatation of the Aorta |
|
| Year 5 Ear infections |
|
| Year 5 High Blood Pressure |
|
| Year 5 Hypothyroidism |
|
| Year 5 Scoliosis |
|
| Year 6 Diabetes |
|
| Year 6 Dilatation of the Aorta |
|
| Year 6 Ear infections |
|
| Year 6 High Blood Pressure |
|
| Year 6 Hypothyroidism |
|
| Year 6 Scoliosis |
|
| Year 7 Diabetes |
|
| Year 7 Dilatation of the Aorta |
|
| Year 7 Ear infections |
|
| Year 7 High Blood Pressure |
|
| Year 7 Hypothyroidism |
|
| Year 7 Scoliosis |
|
| Year 8 Diabetes |
|
| Year 8 Dilatation of the Aorta |
|
| Year 8 Ear infections |
|
| Year 8 High Blood Pressure |
|
| Year 8 Hypothyroidism |
|
| Year 8 Scoliosis |
|
| Year 9 Dilatation of the Aorta |
|
| Year 9 Ear infections |
|
| Year 9 High Blood Pressure |
|
| Year 9 Hypothyroidism |
|
| Year 9 Scoliosis |
|
| Year 10 Scoliosis |
|
| Age 10 Right Ear |
|
| Age 10 Left Ear |
|
| Age 16 Right Ear |
|
| Age 16 Left Ear |
|
| Endpoint Right Ear |
|
| Endpoint Left Ear |
|
| Age 16 (n=7, 9) |
|
| Endpoint (n=24, 22) |
|
| Baseline Right Ear Air (n=36, 32) |
|
| Baseline Right Ear Bone (n=36, 32) |
|
| Age 10 Left Ear Air (n=27, 21) |
|
| Age 10 Left Ear Bone (n=27, 21) |
|
| Age 10 Right Ear Air (n=27, 22) |
|
| Age 10 Right Ear Bone (n=27, 22) |
|
| Age 16 Left Ear Air (n=7, 9) |
|
| Age 16 Left Ear Bone (n=7, 9) |
|
| Age 16 Right Ear Air (n=7, 9) |
|
| Age 16 Right Ear Bone (n=7, 9) |
|
| Endpoint Left Ear Air (n=20, 20) |
|
| Endpoint Left Ear Bone (n=20, 20) |
|
| Endpoint Right Ear Air (n=20, 20) |
|
| Endpoint Right Ear Bone (n=20, 20) |
|