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 @ 4:32 PM
Ignite Modification Date: 2025-12-25 @ 2:24 PM
NCT ID: NCT02625766
Description: None
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT02625766
Study Brief: Pelvis RCT: Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Operative Patients enrolled in the operative treatment group will undergo surgical intervention for their pelvic fracture. The surgeon will decide the best surgical technique as per standard of care for the patient's injury. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments to determine if the injury is healing properly. If additional surgery is required or other complications arise, this will be recorded within the study follow-up forms. LC fracture surgical fixation 0 None 0 47 3 47 View
Non-operative Patients enrolled in the non-operative treatment group will not undergo surgical intervention for their pelvic fracture. They will mobilize as per the surgeon's instructions according to standard of care of for this injury. X-rays will be taken at follow-up clinic appointments to determine if the injury is healing properly or if the pelvis has shifted and may warrant surgical intervention. If complications arise and/or surgery is required, crossover will be allowed and recorded within study follow-up forms. LC fracture non-operative management 0 None 0 48 4 48 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
hardware loosening NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures Hardware loosening View
Wound seroma requiring drainage NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures Wound seroma View
Unplanned fixation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures Unplanned fixation View