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 @ 5:53 PM
Ignite Modification Date: 2025-12-25 @ 3:18 PM
NCT ID: NCT02943668
Description: None
Frequency Threshold: 0
Time Frame: Enrollment through 30 days after the last administration of the study treatment
Study: NCT02943668
Study Brief: Deferasirox in Treating Patients With Very Low, Low, or Intermediate-Risk Red Blood Cell Transfusion Dependent Anemia or Myelodysplastic 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
Treatment (Deferasirox) Patients receive deferasirox PO QD. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Deferasirox: Given PO Laboratory Biomarker Analysis: Correlative studies 1 None 1 2 1 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.03 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Clostrid Difficile NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.03 View
Sinus Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.03 View
Fracture- Lft. Lateral Tibia Plateau NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 4.03 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 4.03 View
Fracture- Lft. Second Metatarsal NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 4.03 View
Fracture- Lft. Wrist NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 4.03 View
Hemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.03 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.03 View
A-fib w/ rapid ventricular rate NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.03 View
Anemia- due to acute blood loss NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.03 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.03 View
Weight loss NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.03 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.03 View
Elevated Creatine/ urine protein NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.03 View
Alanine Amniotransferase- increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.03 View
Asparate Aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.03 View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.03 View