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 @ 9:23 PM
Ignite Modification Date: 2025-12-25 @ 7:09 PM
NCT ID: NCT05342532
Description: None
Frequency Threshold: 0
Time Frame: 6 weeks
Study: NCT05342532
Study Brief: High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
High Dose Dual Therapy This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily. Amoxicillin: 1 g Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals. 0 None 0 58 5 58 View
Standard Triple Therapy This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily. Amoxicillin: 1 g Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals. Clarithromycin: 500 mg twice daily 0 None 0 54 20 54 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Dysguesia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View