Adverse Events Module

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 @ 10:44 PM
Ignite Modification Date: 2025-12-26 @ 10:44 PM
NCT ID: NCT01937312
Description: An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. All AEs were obtained as solicited and spontaneous comments from the subjects, and as observations by the Investigator, as outlined in the study protocol.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were collected for the duration of the study, Oct 2013-May 2014. Adverse events are reported as pre-treatment and treatment-emergent. The treatment-emergent analysis set included all subjects exposed to investigational product.
Study: NCT01937312
Study Brief: Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pre-Treatment Prostaglandin analogue, 1 drop in each eye at bedtime for a 4-week run-in period None None 0 282 2 282 View
SIMBRINZA 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks None None 1 93 16 93 View
Vehicle 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks None None 0 95 8 95 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (16.0) View
Metastatic malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (16.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vision Blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (16.0) View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (16.0) View
Eye Pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (16.0) View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (16.0) View