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 @ 2:17 PM
Ignite Modification Date: 2025-12-25 @ 12:54 PM
NCT ID: NCT05283395
Description: An AE was defined as any untoward medical occurrence associated with the administration of the study intervention in humans, whether or not considered related to the study medication. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the investigator. This analysis population includes subjects who have received at least 1 dose of study medication.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were collected for the duration of individual participation in the study, approximately 12 weeks (±7 days).
Study: NCT05283395
Study Brief: Rocklatan® Evaluation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rocklatan (Latanoprost Mono) Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost mono medical therapy regimen) 0 None 0 61 9 61 View
Rocklatan (Latanoprost +1) Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +1 medical therapy regimen) 0 None 0 45 10 45 View
Rocklatan (Latanoprost +2) Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +2 medical therapy regimen) 0 None 1 30 6 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctival hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25.0 View