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 @ 3:03 AM
Ignite Modification Date: 2025-12-26 @ 1:43 AM
NCT ID: NCT05251233
Description: * Adverse events that are considered surgical complications and are unrelated to treatment with PPI/placebo are only collected for the secondary outcome measure of surgical complications and are not presented in the adverse event module. * Adverse events were not collected on those participants who were in the unrandomized arm. Those participants were enrolled but were never randomized to PPI or placebo.
Frequency Threshold: 0
Time Frame: - Adverse events were collected from start of treatment through 30 days after last day of PPI/placebo (up to 40 days). - All-cause mortality was collected from enrollment through 90 days after surgery (up to 90 days).
Study: NCT05251233
Study Brief: Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo -Visually equivalent placebo once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier). 3 None 0 18 0 18 View
Proton Pump Inhibitor -Pantoprazole once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier). 0 None 0 20 0 20 View
Unassigned Arm For patients who were enrolled but did not get randomized or receive any treatment. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):