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 @ 5:51 PM
Ignite Modification Date: 2025-12-25 @ 3:16 PM
NCT ID: NCT00520468
Description: None
Frequency Threshold: 5
Time Frame: 2 years 2 months
Study: NCT00520468
Study Brief: Treatment of Myelodysplastic Syndrome (MDS) With Cytokine-Immunotherapy for Low-Risk MDS
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cytokine-Immunotherapy Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily None None 11 14 11 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
hemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Elevated creatinine SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Dizziness SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
elevated creatinine SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Puritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View