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 @ 5:24 PM
Ignite Modification Date: 2025-12-25 @ 2:59 PM
NCT ID: NCT00828750
Description: None
Frequency Threshold: 5
Time Frame: Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
Study: NCT00828750
Study Brief: Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Eltrombopag Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment. None None 6 19 19 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lumbar spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Cystitis-like symptom SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Mallory-Weiss syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Parotitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Tinea infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastritis atrophic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastritis erosive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Reflux oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Tongue discolouration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Asthenopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Chalazion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Idiopathic thrombocytopenic purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Tenosynovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Periarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Heat rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Papule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Seborrhoeic dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Excoriation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Lip injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Glucose urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Upper respiratory tract inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Metabolic disorder SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Genital haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Uterine prolapse SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Presbyacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.1 View
Lip neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View