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: 2025-12-25 @ 4:17 AM
Ignite Modification Date: 2025-12-26 @ 3:17 AM
NCT ID: NCT05038020
Description: Three participants were enrolled and none completed the study. All participants were allocated to randomized treatment with AKST4290, and no participants received placebo.
Frequency Threshold: 0
Time Frame: The planned timeframe for adverse event (AE) collection was from the first dose of the study drug until the post-treatment follow-up period (baseline to Week 28). However, the study was terminated early by the sponsor. At the time of termination, 3 participants were enrolled and none completed the study. Enrolled subjects had a safety visit at 30 and 60 days following study drug discontinuation.
Study: NCT05038020
Study Brief: A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AKST4290 Subjects will receive AKST4290, 400mg twice daily, for 24 weeks AKST4290: Oral AKST4290 0 None 0 3 2 3 View
Placebo Subjects will receive matching Placebo, twice daily, for 24 weeks Placebo: Oral Placebo 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View