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: 2025-12-25 @ 1:27 AM
Ignite Modification Date: 2025-12-25 @ 11:38 PM
NCT ID: NCT01891994
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT01891994
Study Brief: Extended Dosing With Eltrombopag for Severe Aplastic Anemia
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 Eltrombopag was administered for 6 months at a dose of 150mg daily in patients \> 12 years of age, 75mg daily for patients 6 to 11 years of age, and 2.5 mg/kg/day for children 2-5 years of age. 1 None 13 40 39 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Bile duct stenosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Otitis media SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infusion related reaction SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Urticaria SYSTEMATIC_ASSESSMENT Immune system disorders None View
Clostridium difficile Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Craniocerebral Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ovarian haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Catheter placement SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hip arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Acute Myeloid Leukaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Conjunctival pallor SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Ocular icterus SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Petechiae SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anogenital warts SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Aphthous ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Impaired gastric emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Large intestine polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mouth haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tooth infection SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Flushing SYSTEMATIC_ASSESSMENT General disorders None View
Hot flush SYSTEMATIC_ASSESSMENT General disorders None View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders None View
Infusion related reaction SYSTEMATIC_ASSESSMENT General disorders None View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Mucosal infection SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nail infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Papilloma viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Trichomoniasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blister SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Iron overload SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations None View
Computerised tomogram SYSTEMATIC_ASSESSMENT Investigations None View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations None View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations None View
Weight increased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypermagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Axillary mass SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Intervertebral disc degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lipoma SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nonallopathic lesions of head region, not elsewhere classified SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteochondrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Ovarian Cyst SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urinary incontinence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper-airway cough syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hair colour changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Papulopustular rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Photosensitivity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Seborrhoeic dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ear Infection SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
External ear inflammation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Otitis externa SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Otitis media SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye disorder SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders None View
Macular cyst SYSTEMATIC_ASSESSMENT Eye disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral candidiasis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pelvic pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Periodontal disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Systemic inflammatory response syndrome SYSTEMATIC_ASSESSMENT General disorders None View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hepatic cyst SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Psoriasis SYSTEMATIC_ASSESSMENT Immune system disorders None View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Immune system disorders None View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lip infection SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Localised oedema SYSTEMATIC_ASSESSMENT Cardiac disorders None View