Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 4:40 PM
Ignite Modification Date: 2025-12-25 @ 2:29 PM
NCT ID: NCT01897766
Description: The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Frequency Threshold: 0
Time Frame: Approximately 11.58 years
Study: NCT01897766
Study Brief: Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Genotropin [Somatropin (Genetical Recombination)] Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively. 1 None 32 482 105 482 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Campylobacter gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Meningitis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Bone neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Cardiac disorder NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Kawasaki's disease NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Sleep apnoea syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Upper respiratory tract inflammation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Henoch-Schonlein purpura NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Osteochondrosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Scoliosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Synovial disorder NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Cryptorchism NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 19.1 View
Condition aggravated NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Patella fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Snake bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Subdural haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Pigmentation lip NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Thyroiditis NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.1 View
Conjunctivitis allergic NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Injection site haemorrhage NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Injection site urticaria NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Hepatic function abnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Food allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.1 View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.1 View
Adenoviral upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Beta haemolytic streptococcal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Bronchitis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Dermatitis infected NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Erythema infectiosum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Exanthema subitum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
H1N1 influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Impetigo NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Molluscum contagiosum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Otitis externa NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Otitis media acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Parotitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Streptococcal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Subcutaneous abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Tracheobronchitis mycoplasmal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Varicella NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Meniscus injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Thermal burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood cholesterol increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood glucose increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood thyroid stimulating hormone decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood thyroid stimulating hormone increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood urea increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood urine present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Body mass index increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Glucose urine NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Glycosylated haemoglobin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Insulin-like growth factor increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Protein urine present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
White blood cell count increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Glucose tolerance impaired NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hyperinsulinaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hypertriglyceridaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Obesity NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Arthropathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Scoliosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Neurofibroma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Orthostatic intolerance NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Attention deficit/hyperactivity disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Autism spectrum disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Tic NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Orthostatic proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Renal glycosuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Renal haemorrhage NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Rhinitis allergic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Upper respiratory tract inflammation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Asteatosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Dermal cyst NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Dermatitis atopic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Eczema asteatotic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Oral surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 19.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Lymphadenitis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Arnold-Chiari malformation NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 19.1 View
Spine malformation NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 19.1 View
Hyperthyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.1 View