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 @ 9:44 PM
Ignite Modification Date: 2025-12-25 @ 7:25 PM
NCT ID: NCT02671032
Description: None
Frequency Threshold: 0
Time Frame: 12 months and 30 days
Study: NCT02671032
Study Brief: CHANGE Feasibility Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Implantation With Nucleus CI532 Cochlear Implant All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant. Nucleus CI532 cochlear implant 0 None 0 12 7 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Jaw ache NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Abscess in left breast NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cactus injury to wrist NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hip pain left and right sides NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Discomfort/Pain of Pinna and Behind NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Onset of tinnitus in right ear NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Drop in hearing NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Nausea NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cold-like symptoms including sinus congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Incision site pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Incision site tenderness NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Otitis Externa NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Polymyalgia Rheumatica NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Arm infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain in body joints NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sun spot removal (actinic keratosis) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View