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 @ 11:57 PM
Ignite Modification Date: 2025-12-25 @ 9:54 PM
NCT ID: NCT02842151
Description: Adverse Events (AEs) were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the clinical investigation. Safety Analysis Set
Frequency Threshold: 5
Time Frame: IOL implantation through study completion, an average of 3 months
Study: NCT02842151
Study Brief: Optimizing the Assessment of Refractive Outcomes After Cataract Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Non-ocular Adverse Events At risk population for non-ocular adverse events is included with units of subjects. 0 None 2 150 0 150 View
Ocular Adverse Events At risk population for ocular adverse events is included with units of eyes. 0 None 4 150 9 150 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
Cystoid macular oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (19.0) View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (19.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye inflammation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (19.0) View