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 @ 12:13 AM
Ignite Modification Date: 2025-12-25 @ 10:14 PM
NCT ID: NCT00991458
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00991458
Study Brief: Study of Cyclosporine in Post-LASIK Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cyclosporine 0.005% Eye Drops Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery. None None 0 209 66 209 View
Placebo (Vehicle for Cyclosporine) Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery. None None 3 205 66 205 View
Cyclosporine 0.010% Eye Drops Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery. None None 2 207 78 207 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Clavicle Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 14.0 View
Haemorrhagic Ovarian Cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA Version 14.0 View
Abortion Spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA Version 14.0 View
Pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA Version 14.0 View
Refraction Disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry Eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 14.0 View
Punctate Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 14.0 View
Vision Blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 14.0 View