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 @ 6:26 PM
Ignite Modification Date: 2025-12-25 @ 3:57 PM
NCT ID: NCT01425268
Description: All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT01425268
Study Brief: Patient Controlled Tissue Expansion for Breast Reconstruction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AeroForm Tissue Expansion AeroForm Tissue Expansion inflation with carbon dioxide by remote control AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander. 0 None 21 99 46 99 View
Saline Tissue Expansion Saline Tissue Expansion inflated by needle injections of saline Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline. 0 None 7 52 22 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hematoma, Breast SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (14.1) View
Stroke, Mild SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.1) View
Neutropenic Fever SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (14.1) View
Red Breast Syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (14.1) View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (14.1) View
Extrusion SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.1) View
Hematoma, Chest VAP Site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (14.1) View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.1) View
Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.1) View
Delayed Wound Healing SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (14.1) View
Wound Dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (14.1) View
Erosion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (14.1) View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (14.1) View
Deflation SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.1) View
Under-Expansion SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.1) View
Over-Expansion SYSTEMATIC_ASSESSMENT Product Issues MedDRA (14.1) View
Exposure SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.1) View
Muscle Disruption SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (14.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.1) View
Delayed Wound Healing SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (14.1) View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (14.1) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.1) View