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 @ 1:07 AM
Ignite Modification Date: 2025-12-25 @ 11:19 PM
NCT ID: NCT04735393
Description: None
Frequency Threshold: 5
Time Frame: Safety assessment period (6 weeks or 12 months)
Study: NCT04735393
Study Brief: A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vehicle (6-week) Vehicle was administered four times daily for four weeks followed by two times daily for two weeks. 0 None 0 251 8 251 View
Reproxalap (12-month) Reproxalap was administered four times daily for four weeks followed by two times daily for 11 months. 0 None 3 299 127 299 View
Reproxalap (6-week) Reproxalap was administered four times daily for four weeks followed by two times daily for two weeks. 0 None 0 503 205 503 View
Vehicle (12-month) Vehicle was administered four times daily for four weeks followed by two times daily for 11 months. 2 None 5 148 3 148 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
COVID-19 Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Unknown cause of death SYSTEMATIC_ASSESSMENT General disorders None View
Premature ventricular contractions SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Unstable Angina SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Worsening coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Right tonsil squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Worsening of chronic back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Supraventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
General disorders and administration site conditions SYSTEMATIC_ASSESSMENT General disorders None View