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 @ 9:36 PM
Ignite Modification Date: 2025-12-25 @ 7:19 PM
NCT ID: NCT05913232
Description: Treatment-emergent adverse events (TEAE) are defined as AEs starting on or after the first dose of IP. A pre-existing event that worsens in severity after receiving the first dose of IP is treated as a new TEAE with date of onset set to the date of the increased severity. An ocular event is an event where the site of the event is reported as both eyes (OU), right eye (OD) or left eye (OS).
Frequency Threshold: 5
Time Frame: 28 days
Study: NCT05913232
Study Brief: Study of Safety and Efficacy of H-1337 in 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
H-1337 0.6% Ophthalmic Solution b.i.d. One drop H-1337 twice daily in the study eye for 28 days H-1337 0.6%: ophthalmic solution 0 None 0 51 19 51 View
H-1337 1.0% Ophthalmic Solution b.i.d. One drop H-1337 twice daily in the study eye for 28 days H-1337 1.0%: ophthalmic solution 0 None 0 51 28 51 View
H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days H-1337 1.0%: ophthalmic solution H-1337 Placebo: ophthalmic solution 0 None 0 50 29 50 View
Timolol 0.5% Ophthalmic Solution b.i.d. One drop Timolol twice daily in the study eye for 28 days Timolol 0.5%: ophthalmic solution 0 None 0 49 8 49 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctival hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (26) View
Instillation site irritation SYSTEMATIC_ASSESSMENT General disorders MedDRA (26) View