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 @ 10:12 PM
Ignite Modification Date: 2025-12-25 @ 7:47 PM
NCT ID: NCT04620135
Description: An overall summary was presented including the number of treatment emergent AEs (TEAEs) and the number and percentage of subjects who experienced at least one TEAE, as well as categorized overall summaries for TEAEs (ocular and non-ocular), TE-SAEs, treatment-related TEAEs and TE-SAEs, TEAEs by maximum severity and by relationship to study drug, TEAEs leading to treatment or study discontinuation, and TEAEs resulting in death.
Frequency Threshold: 5
Time Frame: Volunteered or solicited AEs were collected from the time the subject received the first dose of study medication until Week 4 (Day 29) or study discontinuation. Unresolved AEs at the time of study exit were followed with proper medical care until the event was considered resolved or stabilized, the subject was lost to follow-up, or another resolution to the event was identified.
Study: NCT04620135
Study Brief: Efficacy and Safety Study of Netarsudil 0.02% Ophthalmic Solution Compared to Ripasudil Hydrochloride Hydrate 0.4% Ophthalmic Solution in Japanese Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle 1 drop netarsudil 0.02% in the evening and 1 drop netarsudil vehicle in the morning in each eye. Netarsudil ophthalmic solution 0.02%: Topical sterile ophthalmic solution Other Name: Rhopressa® 0 None 0 122 73 122 View
Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4% 1 drop ripasudil twice daily in the morning and evening in each eye. Ripasudil hydrochloride hydrate ophthalmic solution 0.4%: Other Name: Glanatec® 0 None 2 123 82 123 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infections and infestations NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA/J, Ver 23.1 View
Skin and subcutaneous tissue disorders NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA/J, Ver 23.1 View
Treatment-Emergent Serious Adverse Event (TE-SAE) NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA/J, Ver 23.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctival hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA/J, Ver 23.1 View
Eye irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA/J, Ver 23.1 View