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 @ 2:27 AM
Ignite Modification Date: 2025-12-26 @ 1:01 AM
NCT ID: NCT02125734
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT02125734
Study Brief: Lung Function and Patient Preference With QVA149 vs. Tiotropium in COPD Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
QVA149 QVA149 None None 1 88 28 88 View
Tiotropium Tiotropium None None 0 88 21 88 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 18.1 View
Eye injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiovascular disorder SYSTEMATIC_ASSESSMENT Cardiac disorders 18.1 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders 18.1 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders 18.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders 18.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 18.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 18.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 18.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 18.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 18.1 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders 18.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 18.1 View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 18.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 18.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 18.1 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations 18.1 View
Escherichia test positive SYSTEMATIC_ASSESSMENT Investigations 18.1 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations 18.1 View
Fluid retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 18.1 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 18.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 18.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 18.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 18.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders 18.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 18.1 View
Hypotonia SYSTEMATIC_ASSESSMENT Nervous system disorders 18.1 View
Nerve compression SYSTEMATIC_ASSESSMENT Nervous system disorders 18.1 View
Renal pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders 18.1 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 18.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 18.1 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 18.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 18.1 View
Increased viscosity of bronchial secretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 18.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 18.1 View
Nasal discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 18.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 18.1 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 18.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 18.1 View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 18.1 View
Upper-airway cough syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 18.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 18.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders 18.1 View