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 @ 12:01 AM
Ignite Modification Date: 2025-12-25 @ 9:58 PM
NCT ID: NCT00784758
Description: All reported adverse events, regardless of relatedness to study
Frequency Threshold: 0
Time Frame: 15 weeks for each subject
Study: NCT00784758
Study Brief: Fenzian Asthma Multicenter Outcomes 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
Fenzian Device Subjects randomized to this arm will receive treatment with the Fenzian Device 0 None 0 40 28 40 View
Sham Device Subjects randomized to this arm will receive treatment with the sham device. 0 None 0 39 21 39 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asthma exacerbation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MeSH View
Other dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MeSH View
Upper respiratory infections NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MeSH View
Other infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MeSH View
Candidiasis, Oral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MeSH View
Exanthema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MeSH View
Musculoskeletal Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MeSH View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MeSH View
Sweating NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MeSH View
Edema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MeSH View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeSH View
Diabetes Mellitus, Type 2 NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MeSH View
Weight loss NON_SYSTEMATIC_ASSESSMENT General disorders MeSH View
Central Nervous System Disorders NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MeSH View
Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MeSH View