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 @ 6:31 PM
Ignite Modification Date: 2025-12-25 @ 4:02 PM
NCT ID: NCT02506257
Description: None
Frequency Threshold: 3
Time Frame: 1 month
Study: NCT02506257
Study Brief: Safety and Tolerability of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
0.04% PHMB 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days 0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days None None 0 26 11 26 View
0.06% PHMB 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days 0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days None None 0 28 23 28 View
0.08% PHMB 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days 0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days None None 0 27 16 27 View
PHMB Vehicle PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days None None 0 9 5 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
eyelid edema NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (10.0) View
conjunctival hypermia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (10.0) View
Instillation site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
conjunctival staining NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
corneal staining NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Instillation site pain erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Instillation site pruritus NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Instillation site foreign body sensation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (10.0) View
nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View