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 @ 11:13 PM
Ignite Modification Date: 2025-12-25 @ 8:47 PM
NCT ID: NCT03338569
Description: None
Frequency Threshold: 0
Time Frame: 28 days
Study: NCT03338569
Study Brief: Vitamin C and Septic Shock
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo designed to mimic intervention Placebo: Placebo designed to mimic intervention 26 None 3 64 9 64 View
Intervention Vitamin C Vitamin C: Continuous infusion of vitamin C 16 None 4 61 8 61 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Elevated Troponin w/o ST elevation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
New or worsening heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arrythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Loose stools SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
New or worsening heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arrythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Elevated Troponin w/o ST elevation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bleeding event SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Maculopapular rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View