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 @ 1:43 PM
Ignite Modification Date: 2025-12-25 @ 12:37 PM
NCT ID: NCT04218695
Description: None
Frequency Threshold: 0
Time Frame: 30 days
Study: NCT04218695
Study Brief: Prophylactic Antibiotics in Admitted Cirrhotics
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 1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization Ceftriaxone: Antibiotic 2 None 3 17 4 17 View
Placebo Normal saline (50cc) once daily for up to one week or until end of hospitalization Normal saline: 50cc intravenous once daily 5 None 5 15 1 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hepatic Failure NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cerebral Edema NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
C. diff cile infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Decompensated cirrhosis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Necrotizing pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pseudoaneurysm sma NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Rectus sheath hematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hospital acquired pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Possible gastrointestinal bleed NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
UTI NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hepatic Encephalopathy NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pruritus with rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
ventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View