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 @ 4:48 AM
Ignite Modification Date: 2025-12-26 @ 3:50 AM
NCT ID: NCT01753518
Description: Not all subjects returned for their postpartum appointment, so the reporting population is Suture (N=93) and Staples (N=96). Subjects could have experienced more than one category of complications.
Frequency Threshold: 0
Time Frame: Post operative complications were collected from December 2012 through June 2014.
Study: NCT01753518
Study Brief: A Clinical Trial of Subcuticular Staples Versus Subcuticular Suture for Cesarean Section Skin Closure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Subcuticular Suture Subcuticular suture has been used for many years to close skin incisions. None None 0 93 7 93 View
Subcuticular Staple Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique. None None 0 96 6 96 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Staple expulsion or suture trimming SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Surgical Site Infection SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Superficial Wound Separation SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Seroma SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Hematoma SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View