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 @ 11:49 PM
Ignite Modification Date: 2025-12-25 @ 9:44 PM
NCT ID: NCT02692651
Description: Adverse events collected with follow-up surveys and by clinical alerts.
Frequency Threshold: 5
Time Frame: Treatment period + 30 days, ranging from a total of 40 to 114 days.
Study: NCT02692651
Study Brief: A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fidaxomicin Fidaxomicin pill 200 mg PO 2 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer. 7 None 11 74 0 74 View
Vancomycin Vancomycin solution 125 mg PO 4 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer. 11 None 13 70 0 70 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hospitalization SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hospitalization SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hospitalization SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hospitalization SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hospitalization SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hospitalization SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):