Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:20 AM
Ignite Modification Date: 2025-12-26 @ 3:21 AM
NCT ID: NCT01716520
Description: SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
Frequency Threshold: 3
Time Frame: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
Study: NCT01716520
Study Brief: Cross-Over Study in Subjects With COPD, Evaluating Lung Function Response After Treatment With Once Daily Umeclidinium 62.5mcg, Vilanterol 25mcg, and Umeclidinium/Vilanterol 62.5/25mcg
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 62.5 µg Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days. None None 3 171 8 171 View
VI 25 µg Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days. None None 1 171 13 171 View
UMEC/VI 62.5/25 µg Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days. None None 3 173 13 173 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Oesophageal carcinoma 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
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View