Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:46 AM
Ignite Modification Date: 2025-12-26 @ 1:27 AM
NCT ID: NCT01528033
Description: Mortality is presented for the ITT Population (NPWT N=256; SCWT N=251). AEs and SAEs were only collected if treatment-related. NPWT-, SCWT- and wound-related AEs were analyzed based on the Therapy Compliant (TC) population (study participants without unauthorized treatment changes) (N total NPWT=234; N total SCWT=201).This enables a clear assignment of the adverse event to one of the two treatment methods for study participants who actually received the randomized therapy.
Frequency Threshold: 0
Time Frame: 42 days for Adverse Events (AEs) and unsustained wound closures 132 days for Serious Adverse Events (SAEs)
Study: NCT01528033
Study Brief: Treatment Study of Vacuum Assisted Closure for Postsurgical Subcutaneous Abdominal Wound Healing Impairments
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NPWT Negative Pressure Wound Therapy 24 None 22 234 41 234 View
SCWT Standard Conventional Wound Treatment 15 None 12 201 22 201 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Adverse Device Events (NPWT-related) SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Conventional Wound Treatment-related SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Wound-related SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Adverse Device Events (NPWT-related) SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Conventional Wound Treatment - related SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Wound-related SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View