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| ID | Type | Description | Link |
|---|---|---|---|
| B9R-EW-GDFC | Other Identifier | ELI Lilly and Company |
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GeNeSIS is an open-label, multinational, multicenter, observational study to evaluate the safety and effectiveness of Humatrope treatment.
GeNeSIS is a modular program that includes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated | Participants treated with somatropin for improvement of growth |
| |
| Untreated | Untreated participants with presence or history of neoplastic disease evaluated for endocrine or growth disorder or with any SHOX deficiency related disorder |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatropin (recombinant deoxyribonucleic acid [rDNA] origin) | Drug | Dose, frequency and duration at discretion of attending physician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Type 2 Diabetes Mellitus in GH-treated Participants | Year 15 | |
| Primary Malignancies in Participant Without Previous Cancer History | Due to the small number of participants involved, untreated and unknown treatment groups, data was not provided and could not be calculated. | Year 15 |
| Final Height (FH) Gain by Diagnostic Group | The standard deviation score (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. Due to the small number of participants involved, untreated and unknown treatment groups, data was not provided and could not be calculated. | Baseline through Year 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Defects in Genes Associated With Pituitary Development | Percentage of participants with genetic defects associated with pituitary development. Genes included but were not limited to GH1, Growth hormone releasing hormone receptor (GHRHR), Homeobox gene expressed in embryonic stem cells (HESX1), LIM homeobox 3 (LHX3), POU domain, class 1, transcription factor 1 (POU1F1), and Prophet of Pit1 (PROP1). |
Not provided
Inclusion Criteria:
All participants participating in GeNeSIS must be enrolled in the core study. Participants for whom written consent to release information is provided may enter the core study if they meet any of the following inclusion guidelines:
Exclusion Criteria:
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Clinics and private practices
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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 hours, EST) | Eli Lilly and Company | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30219920 | Derived | Child CJ, Zimmermann AG, Chrousos GP, Cummings E, Deal CL, Hasegawa T, Jia N, Lawrence S, Linglart A, Loche S, Maghnie M, Perez Sanchez J, Polak M, Predieri B, Richter-Unruh A, Rosenfeld RG, Yeste D, Yorifuji T, Blum WF. Safety Outcomes During Pediatric GH Therapy: Final Results From the Prospective GeNeSIS Observational Program. J Clin Endocrinol Metab. 2019 Feb 1;104(2):379-389. doi: 10.1210/jc.2018-01189. | |
| 30201821 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treated | Treatment with Humatrope for improvement of growth. Growth Hormone (GH) product. |
| FG001 | Untreated | No treatment with Humatrope in participants with a history of neoplasia or in those with any short stature homeobox containing gene (SHOX) deficiency-related disorder . |
| FG002 | Treatment with Humatrope unknown. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treated | Treatment with Humatrope for improvement of growth. |
| BG001 | Untreated | No treatment with Humatrope in participants with a history of neoplasia or in those with any SHOX deficiency-related disorder. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age unavailable for 136 treated participants, 10 untreated participants, and 49 unknown participants. |
| 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 | Type 2 Diabetes Mellitus in GH-treated Participants | All treated participants with available age and calculable follow-up time. The treated participants were not compared with untreated but with rates from general population registries. The untreated participants predominantly contained neoplasm or SHOX deficient diagnoses, therefore had significant baseline differences from treated participants. | Posted | Number | Incident Cases | Year 15 |
|
|
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 | Treatment with Humatrope for improvement of growth. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA E18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Turner's syndrome | Congenital, familial and genetic disorders | MedDRA E18.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| D004274 | DNA, Recombinant |
| D004275 | DNA, Ribosomal |
| D013006 | Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
Not provided
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If participant consented a DNA sample is kept until the end of the study
| Baseline through Year 15 |
| Predicted First Year Height Gain Versus Actual First Year Height Gain | The value for predicted and observed is of limited bearing, it is how each participant's predicted versus observed height gain compare and this is best estimated by the R-squared. An estimation parameter would not be a correct format for the R2 data. R2 can take value between 0 and 1 with values closer to 0 representing a poor fit while values closer to 1 representing a perfect fit | Baseline through Year 15 |
| Change From Baseline to Final Height in Anthropometric Measures for Participants With SHOX Deficiency | Baseline, Year 15 |
| Percentage of Participants With Recurrent Neoplasms and Second Neoplasms in Childhood Cancer Survivors | Percentage of participants with recurrence/progression of primary neoplastic disease and/or development of secondary neoplasms in childhood cancer survivors. | Baseline through Year 15 |
| Percentage of Participants With De Novo Neoplasms | Percentage of participants with the development of de novo neoplastic disease with no history of prior neoplasia. | Baseline through Year 15 |
| Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses | Baseline through Year 15 |
| Derived |
| Deal C, Kirsch S, Chanoine JP, Lawrence S, Cummings E, Rosolowsky ET, Marks SD, Jia N, Child CJ; GeNeSIS National Board on behalf of the GeNeSIS Canada Investigators. Growth hormone treatment of Canadian children: results from the GeNeSIS phase IV prospective observational study. CMAJ Open. 2018 Sep 10;6(3):E372-E383. doi: 10.9778/cmajo.20180020. Print 2018 Jul-Sep. |
| 28575299 | Derived | Quigley CA, Child CJ, Zimmermann AG, Rosenfeld RG, Robison LL, Blum WF. Mortality in Children Receiving Growth Hormone Treatment of Growth Disorders: Data From the Genetics and Neuroendocrinology of Short Stature International Study. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3195-3205. doi: 10.1210/jc.2017-00214. |
| 24088548 | Derived | Blum WF, Deal C, Zimmermann AG, Shavrikova EP, Child CJ, Quigley CA, Drop SL, Cutler GB Jr, Rosenfeld RG. Development of additional pituitary hormone deficiencies in pediatric patients originally diagnosed with idiopathic isolated GH deficiency. Eur J Endocrinol. 2013 Nov 22;170(1):13-21. doi: 10.1530/EJE-13-0643. Print 2014 Jan. |
| 23689058 | Derived | Deal C, Hasselmann C, Pfaffle RW, Zimmermann AG, Quigley CA, Child CJ, Shavrikova EP, Cutler GB Jr, Blum WF. Associations between pituitary imaging abnormalities and clinical and biochemical phenotypes in children with congenital growth hormone deficiency: data from an international observational study. Horm Res Paediatr. 2013;79(5):283-92. doi: 10.1159/000350829. Epub 2013 May 16. |
| 21490076 | Derived | Child CJ, Zimmermann AG, Scott RS, Cutler GB Jr, Battelino T, Blum WF; GeNeSIS International Advisory Board. Prevalence and incidence of diabetes mellitus in GH-treated children and adolescents: analysis from the GeNeSIS observational research program. J Clin Endocrinol Metab. 2011 Jun;96(6):E1025-34. doi: 10.1210/jc.2010-3023. Epub 2011 Apr 13. |
| Other Reason per Case Report Form |
|
| Withdrawal by Subject |
|
| Received Another GH Product |
|
| Participant Moved |
|
| Physician Decision |
|
| Sponsor Decision |
|
| Third Party Required to Change Brand |
|
| Lost to Follow-up |
|
| Study Summary Not Completed |
|
| BG002 | Unknown | Treatment with Humatrope unknown. |
| BG003 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Sex/Gender, Customized | No gender available for 32 treated participants, 1 untreated participant, and 49 unknown participants. | Number | participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Diagnostic Groups | Number | participants |
|
| Participants |
|
|
|
| Primary | Primary Malignancies in Participant Without Previous Cancer History | Due to the small number of participants involved, untreated and unknown treatment groups, data was not provided and could not be calculated. | All treated participants with available age, gender, and at least one follow-up excluding participants with previous cancer cases. Due to the small number of participants involved, untreated and unknown treatment groups, data was not provided and could not be calculated. | Posted | Number | Incident Cases | Year 15 |
|
|
|
|
| Primary | Final Height (FH) Gain by Diagnostic Group | The standard deviation score (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. Due to the small number of participants involved, untreated and unknown treatment groups, data was not provided and could not be calculated. | All treated participants who reached final height (at least 1: closed epiphyses, height velocity <2 centimeters per year, or last bone age >14 years [girls] or >16 years [boys]) with baseline height SDS and final height available. Data was not provided for untreated and unknown treatment groups, and could not be calculated. | Posted | Mean | Standard Deviation | standard deviation score | Baseline through Year 15 |
|
|
|
| Secondary | Percentage of Participants With Defects in Genes Associated With Pituitary Development | Percentage of participants with genetic defects associated with pituitary development. Genes included but were not limited to GH1, Growth hormone releasing hormone receptor (GHRHR), Homeobox gene expressed in embryonic stem cells (HESX1), LIM homeobox 3 (LHX3), POU domain, class 1, transcription factor 1 (POU1F1), and Prophet of Pit1 (PROP1). | All SME participants (including treated, untreated, and unknown groups) with available results of DNA (deoxyribonucleic acid) analysis available and GHD diagnosis. | Posted | Number | percentage of participants | Baseline through Year 15 |
|
|
|
| Secondary | Predicted First Year Height Gain Versus Actual First Year Height Gain | The value for predicted and observed is of limited bearing, it is how each participant's predicted versus observed height gain compare and this is best estimated by the R-squared. An estimation parameter would not be a correct format for the R2 data. R2 can take value between 0 and 1 with values closer to 0 representing a poor fit while values closer to 1 representing a perfect fit | All participants with predicted and actual first year height gain available and TS or GHD diagnosis. Data was not provided for untreated and unknown treatment groups, and could not be calculated. | Posted | Number | R Squared | Baseline through Year 15 |
|
|
|
| Secondary | Change From Baseline to Final Height in Anthropometric Measures for Participants With SHOX Deficiency | All SHOX-D Participants, GH-treated, with available height SDS at baseline and final height. Data was not provided for untreated and unknown treatment groups, and could not be calculated. | Posted | Mean | Standard Deviation | standard deviation score | Baseline, Year 15 |
|
|
|
| Secondary | Percentage of Participants With Recurrent Neoplasms and Second Neoplasms in Childhood Cancer Survivors | Percentage of participants with recurrence/progression of primary neoplastic disease and/or development of secondary neoplasms in childhood cancer survivors. | All SME, treated participants with previous neoplastic disease and at least one follow-up visit. Data was not provided for untreated and unknown treatment groups, and could not be calculated. | Posted | Number | percentage of participants | Baseline through Year 15 |
|
|
|
| Secondary | Percentage of Participants With De Novo Neoplasms | Percentage of participants with the development of de novo neoplastic disease with no history of prior neoplasia. | All SME, GH-treated participants with at least one follow-up visit. Data was not provided for untreated and unknown treatment groups, and could not be calculated. | Posted | Number | percentage of participants | Baseline through Year 15 |
|
|
|
| Secondary | Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses | All treated participants with available age and calculable follow-up time, and diabetes mellitus (DM), type 1 diabetes mellitus (T1) or type 2 diabetes mellitus (T2). Data was not provided for untreated and unknown treatment groups, and could not be calculated. | Posted | Number | Incident Cases | Baseline through Year 15 |
|
|
|
|
| 547 |
| 21,177 |
| 6,180 |
| 21,177 |
| EG001 | Untreated | No treatment with somatropin in participants with a history of neoplasia or in those with any SHOX deficiency-related disorder. | 14 | 306 | 126 | 306 |
| EG002 | Treatment with Humatrope unknown. | 0 | 40 | 0 | 40 |
| Aplastic anaemia | Blood and lymphatic system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA E18.1 | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA E18.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA E18.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA E18.1 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA E18.1 | Systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA E18.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA E18.1 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA E18.1 | Systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA E18.1 | Systematic Assessment |
|
| Congestive cardiomyopathy | Cardiac disorders | MedDRA E18.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA E18.1 | Systematic Assessment |
|
| Pulmonary valve disease | Cardiac disorders | MedDRA E18.1 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA E18.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA E18.1 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA E18.1 | Systematic Assessment |
|
| Arnold-chiari malformation | Congenital, familial and genetic disorders | MedDRA E18.1 | Systematic Assessment |
|
| Brachydactyly | Congenital, familial and genetic disorders | MedDRA E18.1 | Systematic Assessment |
|
| Coarctation of the aorta | Congenital, familial and genetic disorders | MedDRA E18.1 | Systematic Assessment |
|
| Congenital aplastic anaemia | Congenital, familial and genetic disorders | MedDRA E18.1 | Systematic Assessment |
|
| Cryptorchism | Congenital, familial and genetic disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hydrocele | Congenital, familial and genetic disorders | MedDRA E18.1 | Systematic Assessment |
|
| Imperforate hymen | Congenital, familial and genetic disorders | MedDRA E18.1 | Systematic Assessment |
|
| Intestinal malrotation | Congenital, familial and genetic disorders | MedDRA E18.1 | Systematic Assessment |
|
| Laryngomalacia | Congenital, familial and genetic disorders | MedDRA E18.1 | Systematic Assessment |
|
| Oculoauriculovertebral dysplasia | Congenital, familial and genetic disorders | MedDRA E18.1 | Systematic Assessment |
|
| Prader-willi syndrome | Congenital, familial and genetic disorders | MedDRA E18.1 | Systematic Assessment |
|
| Rathke's cleft cyst | Congenital, familial and genetic disorders | MedDRA E18.1 | Systematic Assessment |
|
| Tourette's disorder | Congenital, familial and genetic disorders | MedDRA E18.1 | Systematic Assessment |
|
| Ventricular septal defect | Congenital, familial and genetic disorders | MedDRA E18.1 | Systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA E18.1 | Systematic Assessment |
|
| Deafness unilateral | Ear and labyrinth disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA E18.1 | Systematic Assessment |
|
| Middle ear disorder | Ear and labyrinth disorders | MedDRA E18.1 | Systematic Assessment |
|
| Tympanic membrane disorder | Ear and labyrinth disorders | MedDRA E18.1 | Systematic Assessment |
|
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA E18.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA E18.1 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA E18.1 | Systematic Assessment |
|
| Adrenocortical insufficiency acute | Endocrine disorders | MedDRA E18.1 | Systematic Assessment |
|
| Diabetes insipidus | Endocrine disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA E18.1 | Systematic Assessment |
|
| Precocious puberty | Endocrine disorders | MedDRA E18.1 | Systematic Assessment |
|
| Secondary adrenocortical insufficiency | Endocrine disorders | MedDRA E18.1 | Systematic Assessment |
|
| Secondary hypogonadism | Endocrine disorders | MedDRA E18.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA E18.1 | Systematic Assessment |
|
| Deformity of orbit | Eye disorders | MedDRA E18.1 | Systematic Assessment |
|
| Iridocyclitis | Eye disorders | MedDRA E18.1 | Systematic Assessment |
|
| Keratoconus | Eye disorders | MedDRA E18.1 | Systematic Assessment |
|
| Oculogyric crisis | Eye disorders | MedDRA E18.1 | Systematic Assessment |
|
| Papilloedema | Eye disorders | MedDRA E18.1 | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA E18.1 | Systematic Assessment |
|
| Strabismus | Eye disorders | MedDRA E18.1 | Systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA E18.1 | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA E18.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Oesophageal rupture | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Rectal fissure | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Rectal polyp | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Volvulus | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA E18.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA E18.1 | Systematic Assessment |
|
| Cyst | General disorders | MedDRA E18.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA E18.1 | Systematic Assessment |
|
| Device malfunction | General disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hypothermia | General disorders | MedDRA E18.1 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA E18.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA E18.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA E18.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA E18.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA E18.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA E18.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MedDRA E18.1 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Anaphylactoid reaction | Immune system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Kidney transplant rejection | Immune system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Bacterial sepsis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Brain abscess | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Catheter site cellulitis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Cellulitis orbital | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Cholangitis infective | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Encephalitis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Gastroenteritis rotavirus | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Gastroenteritis salmonella | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| H1n1 influenza | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Haemophilus infection | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Hepatitis a | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Hepatitis viral | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Herpes zoster disseminated | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Infectious mononucleosis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Latent tuberculosis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Lymph node tuberculosis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Mastoiditis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Meningitis aseptic | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Meningitis bacterial | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Meningitis viral | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Mycoplasma infection | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Otitis media chronic | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Parainfluenzae virus infection | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Peritonsillar abscess | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Pneumococcal bacteraemia | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Pneumonia mycoplasmal | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Pneumonia pseudomonal | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Rhinovirus infection | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Rotavirus infection | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Shunt infection | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Accident | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Hepatic rupture | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Ligament injury | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Radiation injury | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Shunt malfunction | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Shunt occlusion | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Splenic injury | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Sports injury | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Traumatic renal injury | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA E18.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA E18.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA E18.1 | Systematic Assessment |
|
| Body temperature fluctuation | Investigations | MedDRA E18.1 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA E18.1 | Systematic Assessment |
|
| Insulin-like growth factor increased | Investigations | MedDRA E18.1 | Systematic Assessment |
|
| Salmonella test positive | Investigations | MedDRA E18.1 | Systematic Assessment |
|
| Staphylococcus test positive | Investigations | MedDRA E18.1 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA E18.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA E18.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA E18.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA E18.1 | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA E18.1 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA E18.1 | Systematic Assessment |
|
| Polydipsia | Metabolism and nutrition disorders | MedDRA E18.1 | Systematic Assessment |
|
| Tetany | Metabolism and nutrition disorders | MedDRA E18.1 | Systematic Assessment |
|
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA E18.1 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA E18.1 | Systematic Assessment |
|
| Weight gain poor | Metabolism and nutrition disorders | MedDRA E18.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Bone cyst | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Bone development abnormal | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Bone disorder | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Bone lesion | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Epiphysiolysis | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Extremity contracture | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Juvenile idiopathic arthritis | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Kyphoscoliosis | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Kyphosis | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Limb asymmetry | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Limb deformity | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Posture abnormal | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Acoustic neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Adrenal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Anaplastic astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Burkitt's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Choroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Craniopharyngioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Ependymoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Ewing's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Fibrous cortical defect | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Inflammatory pseudotumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Medulloblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Medulloblastoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Neoplasm recurrence | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Neuroblastoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Neurofibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Optic glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Osteochondroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Osteoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Osteosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Ovarian fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Ovarian germ cell teratoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Pancreatic neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Peripheral nerve sheath tumour malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Phaeochromocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Pituitary tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Pituitary tumour recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Primitive neuroectodermal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Prolactinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Spinal cord neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Testicular germ cell cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Tongue neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Acquired epileptic aphasia | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Benign intracranial hypertension | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Conus medullaris syndrome | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Dyslalia | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Facial paresis | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Haemorrhagic stroke | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hemiplegic migraine | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hypoglycaemic seizure | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Infantile spasms | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Intraventricular haemorrhage | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Meningism | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Migraine with aura | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Moyamoya disease | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Myoclonus | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Paraplegia | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Peroneal nerve palsy | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Petit mal epilepsy | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Status epilepticus | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Tethered cord syndrome | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Unresponsive to stimuli | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Visual field defect | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Anger | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Anorexia nervosa | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Asperger's disorder | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Bipolar disorder | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Conversion disorder | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Eating disorder | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Obsessive-compulsive disorder | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Phobia | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Reactive attachment disorder of infancy or early childhood | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Suicidal behaviour | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA E18.1 | Systematic Assessment |
|
| Anuria | Renal and urinary disorders | MedDRA E18.1 | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA E18.1 | Systematic Assessment |
|
| Glomerulonephritis | Renal and urinary disorders | MedDRA E18.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hypertonic bladder | Renal and urinary disorders | MedDRA E18.1 | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA E18.1 | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA E18.1 | Systematic Assessment |
|
| Post streptococcal glomerulonephritis | Renal and urinary disorders | MedDRA E18.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA E18.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA E18.1 | Systematic Assessment |
|
| Ureteric stenosis | Renal and urinary disorders | MedDRA E18.1 | Systematic Assessment |
|
| Fallopian tube cyst | Reproductive system and breast disorders | MedDRA E18.1 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA E18.1 | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA E18.1 | Systematic Assessment |
|
| Testicular torsion | Reproductive system and breast disorders | MedDRA E18.1 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Allergic respiratory symptom | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Pulmonary artery dilatation | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Snoring | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Tonsillar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Purpura fulminans | Skin and subcutaneous tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Puberty | Social circumstances | MedDRA E18.1 | Systematic Assessment |
|
| Adenoidectomy | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Adenotonsillectomy | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Arthrodesis | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Bone marrow transplant | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Cleft lip repair | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Ear operation | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Eye operation | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Hydrocele operation | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Inguinal hernia repair | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Jejunostomy | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Leg amputation | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Limb operation | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Medical device implantation | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Meningioma surgery | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Nasal septal operation | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Oesophagogastric fundoplasty | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Oophorectomy bilateral | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Orchidectomy | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Orchidopexy | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Osteotomy | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Renal transplant | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Salpingo-oophorectomy bilateral | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Scoliosis surgery | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Spinal fusion surgery | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Tenotomy | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Tonsillectomy | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Ventriculo-peritoneal shunt | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Wisdom teeth removal | Surgical and medical procedures | MedDRA E18.1 | Systematic Assessment |
|
| Angiodysplasia | Vascular disorders | MedDRA E18.1 | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA E18.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA E18.1 | Systematic Assessment |
|
| Vasculitis | Vascular disorders | MedDRA E18.1 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA E18.1 | Systematic Assessment |
|
| Autoimmune thyroiditis | Endocrine disorders | MedDRA E18.1 | Systematic Assessment |
|
| Delayed puberty | Endocrine disorders | MedDRA E18.1 | Systematic Assessment |
|
| Diabetes insipidus | Endocrine disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hypogonadism | Endocrine disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hypopituitarism | Endocrine disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA E18.1 | Systematic Assessment |
|
| Precocious puberty | Endocrine disorders | MedDRA E18.1 | Systematic Assessment |
|
| Primary hypothyroidism | Endocrine disorders | MedDRA E18.1 | Systematic Assessment |
|
| Secondary hypogonadism | Endocrine disorders | MedDRA E18.1 | Systematic Assessment |
|
| Secondary hypothyroidism | Endocrine disorders | MedDRA E18.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA E18.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA E18.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA E18.1 | Systematic Assessment |
|
| No adverse event | General disorders | MedDRA E18.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Multiple allergies | Immune system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA E18.1 | Systematic Assessment |
|
| Blood corticotrophin decreased | Investigations | MedDRA E18.1 | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA E18.1 | Systematic Assessment |
|
| Vitamin d deficiency | Metabolism and nutrition disorders | MedDRA E18.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA E18.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA E18.1 | Systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA E18.1 | Systematic Assessment |
|
| Enuresis | Renal and urinary disorders | MedDRA E18.1 | Systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA E18.1 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA E18.1 | Systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA E18.1 | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA E18.1 | Systematic Assessment |
|
| Ovarian failure | Reproductive system and breast disorders | MedDRA E18.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA E18.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA E18.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA E18.1 | Systematic Assessment |
|
Not provided
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004247 | DNA |
| D009696 | Nucleic Acids |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
|
| All Final Height Gain |
|
|
| GHD Baseline Height |
|
|
| GHD Final Height |
|
|
| GHD Final Height Gain |
|
|
| TS Baseline Height |
|
|
| TS Final Height |
|
|
| TS Final Height Gain |
|
|
| ISS Baseline Height |
|
|
| ISS Final Height |
|
|
| ISS Final Height Gain |
|
|
| SHOX-D Baseline Height |
|
|
| SHOX-D Final Height |
|
|
| SHOX-D Final Height Gain |
|
|
| SGA Baseline Height |
|
|
| SGA Final Height |
|
|
| SGA Final Height Gain |
|
|
| CRI Baseline Height |
|
|
| CRI Final Height |
|
|
| CRI Final Height Gain |
|
|
| Other Baseline Height |
|
|
| Other Final Height |
|
|
| Other Final Height Gain |
|
|
| Unknown Baseline Height |
|
|
| Unknown Final Height |
|
|
| Unknown Final Height Gain |
|
|
|
|
| Arm Span (AS) SDS |
|
|
| SH SDS/Height SDS |
|
|
| AS SDS/Height SDS |
|
|
| AS SDS/SH SDS |
|
|
|
|
| TS DM |
|
|
| ISS DM |
|
|
| SHOX-D DM |
|
|
| SGA DM |
|
|
| Other DM |
|
|
| Unknown DM |
|
|
| All T1 |
|
|
| GHD T1 |
|
|
| TS T1 |
|
|
| ISS T1 |
|
|
| SHOX-D T1 |
|
|
| SGA T1 |
|
|
| Other T1 |
|
|
| Unknown T1 |
|
|
| All T2 |
|
|
| GHD T2 |
|
|
| TS T2 |
|
|
| ISS T2 |
|
|
| SHOX-D T2 |
|
|
| SGA T2 |
|
|
| Other T2 |
|
|
| Unknown T2 |
|
|
Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.
Standardized Incidence Ratio for GHD DM (T1, T2 and DM NOS Combined)
| Standardized Incidence Ratio |
| 2.74 |
| 2-Sided |
| 95 |
| 1.72 |
| 4.15 |
| Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for TS DM (T1, T2 and DM NOS Combined) | Standardized Incidence Ratio | 4.91 | 2-Sided | 95 | 1.80 | 10.69 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for ISS DM (T1, T2 and DM NOS Combined) | Standardized Incidence Ratio | 3.10 | 2-Sided | 95 | 0.84 | 7.93 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for SHOX-D DM (T1, T2 and DM NOS Combined) | Standardized Incidence Ratio | 0.00 | 2-Sided | 95 | 0.00 | 11.83 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for SGA DM (T1, T2 and DM NOS Combined) | Standardized Incidence Ratio | 3.00 | 2-Sided | 95 | 0.36 | 10.83 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for Other DM (T1, T2 and DM NOS Combined) | Standardized Incidence Ratio | 4.55 | 2-Sided | 95 | 1.24 | 11.66 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for Unknown DM (T1, T2 and DM NOS Combined) | Standardized Incidence Ratio | 0.00 | 2-Sided | 95 | 0.00 | 24.30 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for All T1 DM. | Standardized Incidence Ratio | 0.92 | 2-Sided | 95 | 0.56 | 1.44 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for GHD T1DM. | Standardized Incidence Ratio | 0.76 | 2-Sided | 95 | 0.36 | 1.40 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for TS T1DM. | Standardized Incidence Ratio | 1.50 | 2-Sided | 95 | 0.31 | 4.38 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for ISS T1DM. | Standardized Incidence Ratio | 1.42 | 2-Sided | 95 | 0.29 | 4.14 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for SHOX-D T1DM. | Standardized Incidence Ratio | 0.00 | 2-Sided | 95 | 0.00 | 7.23 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for SGA T1DM. | Standardized Incidence Ratio | 0.00 | 2-Sided | 95 | 0.00 | 3.38 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for Other T1DM. | Standardized Incidence Ratio] | 2.09 | 2-Sided | 95 | 0.43 | 6.10 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for Unknown T1DM. | Standardized Incidence Ratio] | 0.00 | 2-Sided | 95 | 0.00 | 14.84 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for All T2 DM. | Standardized Incidence Ratio | 3.79 | 2-Sided | 95 | 2.24 | 5.96 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for GHD T2DM. | Standardized Incidence Ratio | 3.93 | 2-Sided | 95 | 2.03 | 6.87 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for TS T2DM. | Standardized Incidence Ratio | 6.46 | 2-Sided | 95 | 1.33 | 18.89 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for ISS T2DM. | Standardized Incidence Ratio | 0.00 | 2-Sided | 95 | 0.00 | 7.52 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for SHOX-D T2DM. | Standardized Incidence Ratio | 0.00 | 2-Sided | 95 | 0.00 | 31.16 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for SGA T2DM. | Standardized Incidence Ratio | 7.90 | 2-Sided | 95 | 0.96 | 28.52 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for Other T2DM. | Standardized Incidence Ratio | 3.00 | 2-Sided | 95 | 0.08 | 16.70 | Superiority or Other |
| Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity. Standardized Incidence Ratio for Unknown T2DM. | Standardized Incidence Ratio | 0.00 | 2-Sided | 95 | 0.00 | 63.97 | Superiority or Other |