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 @ 5:10 PM
Ignite Modification Date: 2025-12-25 @ 2:47 PM
NCT ID: NCT00200850
Description: None
Frequency Threshold: 0
Time Frame: Up to 18 months
Study: NCT00200850
Study Brief: Immunotherapy Administered Under the Tongue to Treat Dust Mite Allergy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Low Dose Low dose SLIT Hose Dust Mite SLIT: low dose SLIT 143 AU/ml daily 0 None 0 10 10 10 View
High Dose High dose SLIT High dose SLIT: House Dust Mite SLIT- 10,000 AU/ml daily 0 None 0 10 10 10 View
Placebo Placebo Placebo SLIT: Placebo SLIT daily 0 None 0 11 11 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
oral lesion SYSTEMATIC_ASSESSMENT General disorders None View
throat irritation SYSTEMATIC_ASSESSMENT General disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flu SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Head cold SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Reproductive issues SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Eye infection SYSTEMATIC_ASSESSMENT Eye disorders None View
Dermatologic issues SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ear infection SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Optic neuritis SYSTEMATIC_ASSESSMENT General disorders None View
Pain due to wisdom teeth extraction SYSTEMATIC_ASSESSMENT General disorders None View
Muffled hearing SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal issues SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sprain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View