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 @ 9:39 PM
Ignite Modification Date: 2025-12-25 @ 7:21 PM
NCT ID: NCT02230332
Description: None
Frequency Threshold: 5
Time Frame: 8 weeks
Study: NCT02230332
Study Brief: Alendronate to Prevent Loss of Bronchoprotection in Asthma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo capsule taken once daily Placebo 0 None 2 40 13 40 View
Alendronate Alendronate in 10mg capsules taken once daily Alendronate 0 None 0 38 9 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Viral Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ICD-9 View
GI Bleed NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICD-9 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Acute nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ICD-9 View
Esophageal reflux NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICD-9 View
Acute sinusitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ICD-9 View
Acue Upper Respiratory Infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ICD-9 View
asthma exacerbation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ICD-9 View
thrush NON_SYSTEMATIC_ASSESSMENT Infections and infestations ICD-9 View
headache NON_SYSTEMATIC_ASSESSMENT General disorders ICD-9 View
Heartburn NON_SYSTEMATIC_ASSESSMENT General disorders ICD-9 View
Nausea alone NON_SYSTEMATIC_ASSESSMENT General disorders ICD-9 View