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 @ 7:21 PM
Ignite Modification Date: 2025-12-25 @ 5:00 PM
NCT ID: NCT01925703
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01925703
Study Brief: Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sodium Ferric Gluconate Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first. None None 1 13 11 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Clinical Deterioration NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
injection site itching NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
injection site discomfort NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
thrombophlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
cellulitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
leg cramps NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
bladder discomfort NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
melena NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View