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 @ 3:56 PM
Ignite Modification Date: 2025-12-25 @ 2:00 PM
NCT ID: NCT01441492
Description: None
Frequency Threshold: 0
Time Frame: 30 days and 60 days
Study: NCT01441492
Study Brief: Pancreas Resection With and Without Drains
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
No Drains Patients did not receive intraperitoneal drainage following pancreas resection. No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group. None None 2 170 99 170 View
Drains Patients did receive drain(s), the standard of care treatment, following pancreas resection. Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care). None None 0 174 130 174 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Grade 3 intra-abdominal infection and pancreatic leak/fistula SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pancreatic_leak_fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Postoperative_Abdominal_FluidCollection SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Biliary_leak SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Enteric_leak SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Lymph_Leak SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastroparesis_DelayedGastricEmptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
SmallBowelObstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Seroma SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Intra_abd_abscess SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Wound_Dehiscence SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Wound_Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View