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 @ 12:22 PM
Ignite Modification Date: 2025-12-25 @ 12:03 PM
NCT ID: NCT01814761
Description: The Safety Population is used to assess serious adverse events (SAEs) and adverse events (AEs) and included all enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment (same as the intent-to-treat population)
Frequency Threshold: 5
Time Frame: None
Study: NCT01814761
Study Brief: A Study of Bimatoprost 0.01% in the Clinical Setting
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pts With POAG or OH (Previously Treatment Naive) Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%). None None 1 42 10 42 View
Pts With POAG or OH (Switched Monotherapy) Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%). None None 2 270 16 270 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 16.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 16.0 View
Traumatic Intracranial Haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry Eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 16.0 View
Ocular Hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 16.0 View