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 @ 12:05 PM
Ignite Modification Date: 2025-12-25 @ 11:58 AM
NCT ID: NCT00770861
Description: None
Frequency Threshold: 5
Time Frame: Adverse events data were collected for a period of thirteen months, from November 2008 to December 2009.
Study: NCT00770861
Study Brief: A Study on the Efficacy and Safety of Nebivolol Monotherapy in Hispanic Hypertensive 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
Nebivolol Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration None None 0 141 5 141 View
Placebo Matching placebo tablets, oral administration None None 1 136 8 136 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View