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 @ 2:10 AM
Ignite Modification Date: 2025-12-26 @ 12:37 AM
NCT ID: NCT03345160
Description: All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Frequency Threshold: 0
Time Frame: 52 weeks
Study: NCT03345160
Study Brief: Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Peanut Flour: Open Label Peanut OIT This is an open label treatment for subjects who had previously received placebo treatment in a prior peanut OIT study Peanut Flour: open label oral immunotherapy 0 None 0 7 7 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mild allergic reaction-Initial Dose Escalation SYSTEMATIC_ASSESSMENT General disorders None View
Asthma Exacerbation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Allergic Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Strept Throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
GERD-not related to dosing SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mild allergic reaction-Dosing related SYSTEMATIC_ASSESSMENT General disorders None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
influenza SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Otitis Media SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
upper respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Eczema Flare SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vomiting-not associated with dosing SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea-not associated with dosing SYSTEMATIC_ASSESSMENT General disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wrist Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Allergic Reaction -not related to dosing SYSTEMATIC_ASSESSMENT General disorders None View
Otitis Externa SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Back pain-related to a fall SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rash-not related to dosing SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dehydration SYSTEMATIC_ASSESSMENT General disorders None View
Sore Throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View