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: 2025-12-25 @ 4:14 AM
Ignite Modification Date: 2025-12-26 @ 3:13 AM
NCT ID: NCT04852120
Description: None
Frequency Threshold: 5
Time Frame: Adverse Events were recorded from signing the informed consent form (ICF) to about 37(+2) hours after first medication.
Study: NCT04852120
Study Brief: Compound Sodium Picosulfate Granules for Bowel Preparation in Chinese 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
Compound Sodium Picosulfate Granules No intervention: Compound Sodium Picosulfate Granules administered by the patient prior to X-ray examination, endoscopy or surgery when judged clinically necessary in accordance to usual practice consistent with the local prescribing information. 0 None 1 3000 0 3000 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Other Events(If Any):