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 @ 2:14 AM
Ignite Modification Date: 2025-12-26 @ 12:43 AM
NCT ID: NCT01323660
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: On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to Week 33), are reported.
Study: NCT01323660
Study Brief: An Exercise Endurance Study to Evaluate the Effects of Treatment of Chronic Obstructive Pulmonary Disease (COPD) Patients With a Dual Bronchodilator: GSK573719/GW642444.Study B
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants received matching placebo QD via a DPI in the morning for 12 weeks. None None 4 151 31 151 View
UMEC 62.5 µg QD Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks. None None 1 40 5 40 View
UMEC 125 µg QD Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks. None None 1 41 14 41 View
VI 25 µg QD Participants received VI 25 µg QD via a DPI for 12 weeks. None None 2 64 12 64 View
UMEC/VI 62.5/25 µg QD Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks. None None 3 130 20 130 View
UMEC/VI 125/25 µg QD Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks. None None 5 128 18 128 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
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
Metastases to central nervous system 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
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Infective exacerbation of chronic obstructive airways diseas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
IIIrd nerve paresis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Leukocytoclastic vasculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View