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 @ 5:11 AM
Ignite Modification Date: 2025-12-26 @ 4:16 AM
NCT ID: NCT05890027
Description: This eye-based study treated each ptotic eye as an individual unit. Bilateral ptosis participants contributed two eyes; unilateral ptosis participants contributed one eye. All eyes underwent identical sequential interventions and assessments in this single-arm study. Since all participants received the same intervention sequence, adverse events are reported under one arm: "all study participants."
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT05890027
Study Brief: Phenylephrine Versus Eyelid Taping for Muller's Muscle-Conjunctival Resection (MMCR) 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
All Study Participants This study used an eye-based unit of analysis, where each eye with ptosis served as an individual study unit. Participants with bilateral ptosis contributed two eyes to the study, while those with unilateral ptosis contributed one eye. All affected eyes underwent identical interventions and assessments. Study Protocol: Each eye with ptosis underwent the following sequential assessments: 1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position. 2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated. 3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements. All recruited eyes progressed through all testing conditions (baseline, taping, and phenylephrine ophthalmic solution). 0 None 0 18 0 18 View
Serious Events(If Any):
Other Events(If Any):