Adverse Events Module

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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 @ 11:16 PM
Ignite Modification Date: 2025-12-25 @ 8:54 PM
NCT ID: NCT00266656
Description: All enrolled/started participants.
Frequency Threshold: 5
Time Frame: None
Study: NCT00266656
Study Brief: Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Early Treated Humatrope administered according to investigator's clinical practice and guided by the approved package insert. Humatrope administered in B9R-US-GDFG (NCT00406926). None None 6 36 34 36 View
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). None None 5 33 32 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anomalous pulmonary venous connection SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 18.0 View
Atrial septal defect SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 18.0 View
Pterygium colli SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 18.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Lobar pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Scoliosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Medulloblastoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Mediastinal mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Conductive deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.0 View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.0 View
Tympanic membrane perforation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.0 View
Autoimmune thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 18.0 View
Goitre SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 18.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 18.0 View
Myopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Coeliac disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Tooth malformation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.0 View
Multiple allergies SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.0 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Croup infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Impetigo SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Mononucleosis syndrome SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Echocardiogram normal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Electrocardiogram normal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Ultrasound kidney normal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Ultrasound scan normal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Kyphosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Scoliosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Haemangioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Melanocytic naevus SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Skin papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Obsessive-compulsive disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Enuresis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Keloid scar SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Seborrhoea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Seborrhoeic dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Corrective lens user SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 18.0 View
Orthodontic appliance user SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 18.0 View
Adenoidectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Ear tube insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Mole excision SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Oral surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Orthodontic procedure SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Palatal operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Tooth extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Tympanoplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Wisdom teeth removal SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Aortic dilatation SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View