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 @ 5:08 AM
Ignite Modification Date: 2025-12-26 @ 4:12 AM
NCT ID: NCT00619827
Description: A Treatment Emergent Adverse Event (TEAE) is defined as any adverse event that started on or after the first intake of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Frequency Threshold: 5
Time Frame: 4 months.
Study: NCT00619827
Study Brief: Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
300 IR 300 IR grass pollen allergen extract tablet None None 0 45 24 45 View
Placebo Placebo tablet None None 0 44 9 44 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear pruritus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA Version 10.1. View
Oral pruritus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 10.1. View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 10.1. View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 10.1. View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 10.1. View