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 @ 6:37 PM
Ignite Modification Date: 2025-12-25 @ 4:08 PM
NCT ID: NCT01072357
Description: None
Frequency Threshold: 0
Time Frame: 52 Weeks
Study: NCT01072357
Study Brief: Safety and Efficacy of Bevacizumab in High-Risk Corneal Transplant Survival
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Avastin® (Bevacizumab) Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks. The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule. Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks. 0 None 1 15 13 15 View
0.9% NaCl & Refresh Liquigel Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks. The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule. 0.9% NaCl \& Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks 0 None 1 15 13 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Congestive Heart Failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Foreign Body Sensation NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Tearing NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Blurry Vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Ocular Pain NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Photophobia NON_SYSTEMATIC_ASSESSMENT Eye disorders None View