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 @ 5:07 PM
Ignite Modification Date: 2025-12-25 @ 2:45 PM
NCT ID: NCT02270450
Description: CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
Frequency Threshold: 5
Time Frame: From date of registration until death or 53 weeks post registration
Study: NCT02270450
Study Brief: S1316, Surgery or Non-Surgical Management in Treating Patients With Intra-Abdominal Cancer and Bowel Obstruction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Randomization Surgery Patients who are randomized to surgical management undergo therapeutic conventional surgery (abdominal) as defined by the treating physician. 19 None 2 24 5 24 View
Randomization Non-surgical Management Patients on the randomized to non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician. 20 None 3 25 1 25 View
Patient Choice Surgery Patients who choose surgical management undergo conventional surgery (abdominal) as defined by the treating physician as in Arm 1. 37 None 5 58 12 58 View
Patient Choice Non-surgical Management Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2. 68 None 16 92 14 92 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death NOS SYSTEMATIC_ASSESSMENT General disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neoplasms benign, malignant and unspecified - Other SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Renal and urinary disorders-Other SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Gastrointestinal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View