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 @ 5:06 AM
Ignite Modification Date: 2025-12-26 @ 4:09 AM
NCT ID: NCT02941627
Description: Safety Analysis was based on participants for whom the surgery for cochlear implantation was initiated. Among 53 patients enrolled: 1 died for heart stroke after the informed consent process, 1 was not implanted for surgical failure, and 1 for cholesteatoma discovered during surgical procedure. This patient was included in safety analysis as defined in the protocol. Then, among 53 patients enrolled 51 were evaluated for safety outcomes, 50 were successfully implanted and complete the study.
Frequency Threshold: 5
Time Frame: From the participant's cochlear implant surgery initiation to the end of month 12.
Study: NCT02941627
Study Brief: The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Neuro Zti/Neuro One Study Group Neuro Zti: implant Neuro One: sound processor All patient will receive a Neuro Zti implant and fit with Neuro One sound processor. 1 None 3 51 15 51 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diagnosis of Liver Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (22.1) View
Kidney failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (22.1) View
Exacerbation of COPD SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (22.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (22.1) View
Post operative dizziness SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (22.1) View
Post procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (22.1) View