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 @ 11:17 PM
Ignite Modification Date: 2025-12-25 @ 8:55 PM
NCT ID: NCT00612456
Description: Safety population was used for analysis.
Frequency Threshold: 5
Time Frame: Up to follow-up (Day 43)
Study: NCT00612456
Study Brief: To Evaluate the Pharmacodynamics, Safety, and Pharmacokinetics of Pazopanib Drops in Adult Subjects With Neovascular AMD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pazopanib 5 mg/mL TID Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses. 0 None 0 27 7 27 View
Pazopanib 2 mg/mL TID Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses. 0 None 1 27 1 27 View
Pazopanib 5 mg/mL Once Daily Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL once daily for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses. 0 None 0 16 3 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Retinal disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Detachment of retinal pigment epithelium SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Myodesopsia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View