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 @ 10:10 PM
Ignite Modification Date: 2025-12-25 @ 7:45 PM
NCT ID: NCT04089735
Description: None
Frequency Threshold: 5
Time Frame: Serious adverse events were collected from informed consent through Post-operative Day 28 for Study Part A and informed consent through Post-operative Day 22 for Study Part B. Other (not Including Serious) adverse events were collected from the first dose through Post-operative Day 28 for Study Part A; from the first dose through Post-operative Day 22 for Study Part B.
Study: NCT04089735
Study Brief: A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
APP13007 0.05% Twice Daily (BID) 1 drop 0.05% APP13007 twice daily for 21 days to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05% 0 None 0 22 2 22 View
APP13007 0.05% Placebo Twice Daily (BID) 1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05% 0 None 0 23 6 23 View
APP13007 0.05% Twice Daily (BID) and Once Daily (QD) 1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05% 0 None 0 22 2 22 View
APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) 1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05% 0 None 0 22 5 22 View
APP13007 0.1% Twice Daily (BID) and Once Daily (QD) 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1% 0 None 0 22 1 22 View
APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1% 0 None 0 21 2 21 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye inflammation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22.0 View