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 @ 5:26 PM
Ignite Modification Date: 2025-12-25 @ 3:00 PM
NCT ID: NCT03388268
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected through 8 weeks after completion of the study drug.
Study: NCT03388268
Study Brief: TOX NEG Trial: Clostridium Difficile Diagnosis and Treatment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Oral Vancomycin 125mg of oral vancomycin four times per day Oral Vancomycin: Oral vancomycin 125mg 4 times per day Toxin enzyme immunoassay: EIA assay: Wampole/Tech Lab Tox A/B II Nuceleic acid amplification test: NAAT: Xpert C. difficile, Cepheid 0 None 2 8 3 8 View
Placebo Placebo four times per day Placebo: Sugar liquid manufactured to mimic oral vancomycin 125mg Toxin enzyme immunoassay: EIA assay: Wampole/Tech Lab Tox A/B II Nuceleic acid amplification test: NAAT: Xpert C. difficile, Cepheid 0 None 0 7 2 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Volume overload SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypoxemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache, vertigo, nausea/vomiting SYSTEMATIC_ASSESSMENT General disorders None View
Syncope, altered mental status SYSTEMATIC_ASSESSMENT General disorders None View
C. difficile EIA positive stool sample SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View