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 @ 2:28 AM
Ignite Modification Date: 2025-12-26 @ 1:02 AM
NCT ID: NCT01777334
Description: SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug during the Treatment Period.
Frequency Threshold: 3
Time Frame: On-treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until the end of treatment (up to 24 weeks).
Study: NCT01777334
Study Brief: The Purpose of This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotriopium 18 mcg Once Daily Over a 24-week Treatment Period in Subjects With COPD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
UMEC/VI 62.5/25 µg Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks. None None 16 454 71 454 View
TIO 18 µg Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks. None None 17 451 72 451 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Bronchial carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Lung adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Metastases to central nervous system SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Pancreatic carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Rectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Epiglottitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lobar pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure chronic SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Arterial restenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Peripheral artery restenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Mental disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Peripheral artery stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View