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 @ 5:48 PM
Ignite Modification Date: 2025-12-25 @ 3:15 PM
NCT ID: NCT02517268
Description: None
Frequency Threshold: 5
Time Frame: baseline to 3 months after surgery
Study: NCT02517268
Study Brief: Accelerated Recovery Pathway for Discharge After Surgery in Patients With Pancreatic Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard 7-Day Pathway Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy 10 None 0 39 17 39 View
Accelerated 5-Day Pathway Patients follow the Whipple accelerated 5-day pathway following pancreaticoduodenectomy. The accelerated pathway includes more rapidly leaving the ICU setting, early mobilization and enhanced physical therapy, multimodal pain control, dietary modifications, and increased and standardized phone contact by a nurse practitioner during the first week following hospital discharge. Pancreaticoduodenectomy 13 None 1 37 5 37 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Delayed Gastric Emptying NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pancreatic Fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Delayed Gastric Emptying NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pulmonary NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View