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 @ 3:30 AM
Ignite Modification Date: 2025-12-26 @ 2:12 AM
NCT ID: NCT04600505
Description: None
Frequency Threshold: 0
Time Frame: Screening, Day -1 until Follow-up visit, up to 53 days
Study: NCT04600505
Study Brief: A Study to Assess Drug Absorption of Fixed Dose Combinations of Budesonide, Glycopyrronium, and Formoterol
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment A Participants received 2 inhalations of BGF MDI with Propellant 1 - test formulation (Treatment A) 0 None 0 47 9 47 View
Treatment B Participants received 2 inhalations of BGF MDI with Propellant 2 - test formulation (Treatment B) 0 None 0 47 10 47 View
Treatment C Participants received 2 inhalations of BGF MDI with HFA Propellant - reference formulation (Treatment C) 0 None 0 47 10 47 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 23.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 23.1 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 23.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.1 View
Dry throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.1 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.1 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.1 View
Sputum increased NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.1 View
Throat irritation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.1 View
Throat tightness NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.1 View
Upper-airway cough syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.1 View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 23.1 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 23.1 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 23.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 23.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 23.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 23.1 View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 23.1 View
Abnormal dreams NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 23.1 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 23.1 View
Nightmare NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 23.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 23.1 View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 23.1 View
Testicular pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA Version 23.1 View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 23.1 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 23.1 View
Productive cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.1 View
Medical device site dermatitis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 23.1 View
Hypermetropia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 23.1 View