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 @ 12:21 AM
Ignite Modification Date: 2025-12-25 @ 10:25 PM
NCT ID: NCT00390858
Description: None
Frequency Threshold: 5
Time Frame: Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
Study: NCT00390858
Study Brief: A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Children (<12 Years) Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters ( renal and hematology) and whether Liver Iron Concentration (LIC) and serum ferritin were increasing or decreasing None None 4 20 20 20 View
Adolescents ( ≧12 Years) Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters ( renal and hematology) and whether Liver Iron Concentration (LIC) and serum ferritin were increasing or decreasing None None 8 20 20 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Splenomegaly SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatolithiasis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Local swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Biliary colic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Infectious mononucleosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Allergic transfusion reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Pelvic fluid collection SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Cholecystectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Splenectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Tonsillectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Torticollis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Aphonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Nervousness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Nephropathy toxic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Amenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Breast discomfort SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Menstrual disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Polymenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hyperkeratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Ingrowing nail SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pityriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pityriasis alba SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Splenomegaly SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Talipes SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Auricular pseudocyst SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Growth hormone deficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Hypogonadism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eyelid oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Hypermetropia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Ocular icterus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinal degeneration SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Aphthous stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gingivitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal congestion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cyst SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hyperpyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Suprapubic pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Biliary colic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Allergy to plants SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Food allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Acute tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Genital infection female SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Impetigo SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Leptospirosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lymphangitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngotonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyoderma SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tinea versicolour SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Vulvitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Chest injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Eye injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Foreign body trauma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Joint sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Sunburn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Transfusion reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Vertebral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Beta 2 microglobulin urine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood folate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood homocysteine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Creatinine renal clearance decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Glomerular filtration rate abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Glucose urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Protein C decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Urinary casts SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Urine protein/creatinine ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Vitamin E decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Glucose tolerance impaired SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperinsulinism SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypozincaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Vitamin C deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Zinc deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Bone swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck mass SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View