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 @ 1:25 AM
Ignite Modification Date: 2025-12-25 @ 11:36 PM
NCT ID: NCT00967993
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00967993
Study Brief: Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
KRX-0502 (Ferric Citrate) Single arm clinical trial of KRX-0502 (ferric citrate) None None 0 22 8 22 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Exacerbation of Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Loose Stool Intermittent SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Odor of ferric citrate SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Clotted A-V Fistula Recurrent SYSTEMATIC_ASSESSMENT General disorders None View
Exertion Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Strange Feeling in Head SYSTEMATIC_ASSESSMENT General disorders None View
Liver Enzyme Elevation SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Knee Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hand Dysaesthsia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Decrease in Urea Reduction Rate SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash Diffuse SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Low BP Dizziness Weakness SYSTEMATIC_ASSESSMENT Vascular disorders None View
Syncope SYSTEMATIC_ASSESSMENT Vascular disorders None View