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 @ 4:26 PM
Ignite Modification Date: 2025-12-25 @ 2:20 PM
NCT ID: NCT01273766
Description: only patients on Arm I (recieving drug on protocol) were tracked for toxicities
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT01273766
Study Brief: Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Arm blood tested on healthy patients None None 0 0 0 0 View
Correlative treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis None None 0 0 0 0 View
Arm I Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity. deferasirox : Given orally laboratory biomarker analysis : Correlative studies enzyme-linked immunosorbent assay : Correlative studies None None 4 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
hyperglycemia SYSTEMATIC_ASSESSMENT Investigations None View
hyponatremia SYSTEMATIC_ASSESSMENT Investigations None View
hypokalemia SYSTEMATIC_ASSESSMENT Investigations None View
serum glutamic pyruvic transaminase SYSTEMATIC_ASSESSMENT Investigations None View
Thrombosis/thrombus/embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Heartburn/dyspepsia SYSTEMATIC_ASSESSMENT General disorders None View
Confusion SYSTEMATIC_ASSESSMENT General disorders None View
"Distension bloating, abdominal" SYSTEMATIC_ASSESSMENT General disorders None View
Infection Bladder SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lipase SYSTEMATIC_ASSESSMENT Investigations None View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection Sinus SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection with normal ANC or Grade 1 or 2 neutrophils: Nose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Low WBC SYSTEMATIC_ASSESSMENT Investigations None View
low Platelets SYSTEMATIC_ASSESSMENT Investigations None View
Low Hemoglobin SYSTEMATIC_ASSESSMENT Investigations None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal - Other SYSTEMATIC_ASSESSMENT General disorders None View
Alkaline phosphatase SYSTEMATIC_ASSESSMENT Investigations None View
Creatinine SYSTEMATIC_ASSESSMENT Investigations None View
Proteinuria SYSTEMATIC_ASSESSMENT Investigations None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Taste alteration SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Dermatology/Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Weight loss SYSTEMATIC_ASSESSMENT General disorders None View
hyperglycemia SYSTEMATIC_ASSESSMENT Investigations None View
hypoglycemia SYSTEMATIC_ASSESSMENT Investigations None View
hypocalcemia SYSTEMATIC_ASSESSMENT Investigations None View
hypomagnesemia SYSTEMATIC_ASSESSMENT Investigations None View
hyponatremia SYSTEMATIC_ASSESSMENT Investigations None View
hypokalemia SYSTEMATIC_ASSESSMENT Investigations None View
hypoalbuminemia SYSTEMATIC_ASSESSMENT Investigations None View
hyperbilirubinemia SYSTEMATIC_ASSESSMENT Investigations None View
serum glutamic pyruvic transaminase SYSTEMATIC_ASSESSMENT Investigations None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain: Head/headache SYSTEMATIC_ASSESSMENT General disorders None View
serum glutamic oxaloacetic transaminase SYSTEMATIC_ASSESSMENT Investigations None View
hypermagnesemia SYSTEMATIC_ASSESSMENT Investigations None View
hyperkalemia SYSTEMATIC_ASSESSMENT Investigations None View
Ocular/Visual - Other SYSTEMATIC_ASSESSMENT Eye disorders None View
Urinary frequency/urgency SYSTEMATIC_ASSESSMENT General disorders None View
Renal/Genitourinary - Other SYSTEMATIC_ASSESSMENT General disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Intra-operative Injury SYSTEMATIC_ASSESSMENT General disorders None View
Musculoskeletal Soft Tissue - Other SYSTEMATIC_ASSESSMENT General disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT General disorders None View
Dehydration SYSTEMATIC_ASSESSMENT General disorders None View
Pruritus/itching SYSTEMATIC_ASSESSMENT General disorders None View
Rash/desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain: Abdomen SYSTEMATIC_ASSESSMENT General disorders None View
Ataxia SYSTEMATIC_ASSESSMENT General disorders None View
Obstruction Bladder SYSTEMATIC_ASSESSMENT General disorders None View
Pain Bladder SYSTEMATIC_ASSESSMENT General disorders None View
Amylase SYSTEMATIC_ASSESSMENT Investigations None View
Bronchospasm wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urine color change SYSTEMATIC_ASSESSMENT General disorders None View
Dry eye syndrome SYSTEMATIC_ASSESSMENT Eye disorders None View
Anal Incontinence SYSTEMATIC_ASSESSMENT General disorders None View
gamma-Glutamyl transpeptidase SYSTEMATIC_ASSESSMENT Investigations None View
Glomerular filtration rate SYSTEMATIC_ASSESSMENT Investigations None View
Lipase SYSTEMATIC_ASSESSMENT Investigations None View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations None View
Memory impairment SYSTEMATIC_ASSESSMENT General disorders None View
Pain: Muscle SYSTEMATIC_ASSESSMENT General disorders None View
Pain Oral cavity SYSTEMATIC_ASSESSMENT General disorders None View
Pain: Extremity-limb SYSTEMATIC_ASSESSMENT General disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperpigmentation SYSTEMATIC_ASSESSMENT General disorders None View
Mucositis/stomatitis Oral cavity SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Hemorrhage GU: Urinary SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombosis/embolism (vascular access-related) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Mucositis/stomatitis Oral cavity SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection Lip perioral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blood Infection with high grade neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations None View