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: 2025-12-26 @ 1:16 PM
Ignite Modification Date: 2025-12-26 @ 1:16 PM
NCT ID: NCT03304106
Description: None
Frequency Threshold: 0
Time Frame: Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Study: NCT03304106
Study Brief: Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1 Newly implanted recipients 0 None 5 31 17 31 View
Group 2 Existing recipients 0 None 1 56 6 56 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization secondary to losing consciousness from sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalization SYSTEMATIC_ASSESSMENT General disorders None View
Parkinson's disease diagnosis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hospitalization for sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dizziness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vertigo and BPPV SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Abnormal heart rhythm requiring placement of pacemaker SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness and imbalance SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Tongue numbness/mouth numbness SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Headaches SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Change in taste SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Loss of hearing SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
MAP too loud, unable to wear within 48hours of activation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Swelling at CI site (Ear not specified) SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Altered taste post-op SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Occasional dizziness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Sinus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diffuse photodamage of the skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Jaw soreness SYSTEMATIC_ASSESSMENT General disorders None View
Pain behind left ear SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Swelling in face and neck SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
A window blind fell and hit head causing pain on head and neck SYSTEMATIC_ASSESSMENT General disorders None View
Tinnitus began night of surgery after a window blind fell on head SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Tooth Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lip swelling SYSTEMATIC_ASSESSMENT General disorders None View
Arthritis of carpometacarpal joint on left thumb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pinched nerve in back causing pain down right leg SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Left ear tinnitus following surgery SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Increased tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Redness and swelling on implanted ear SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Intermittent dizziness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Right ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Spitting suture at cochlear implant incision site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Left facial pain SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue post-surgery SYSTEMATIC_ASSESSMENT General disorders None View
Tingling, numbing and slight pain at coil/magnet site on head SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Patient experienced uncomfortable loudness SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Flinching to high frequency stimulation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Loudness discomfort and increased tinnitus SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Right lower abdominal pain SYSTEMATIC_ASSESSMENT General disorders None View
Hammer toe surgery left foot SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
MAP too loud; decreased speech perception in noise SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View