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 @ 3:39 AM
Ignite Modification Date: 2025-12-26 @ 2:24 AM
NCT ID: NCT00515502
Description: AEs and SAEs were collected in the members of All Subjects Population comprised of all participants who received at least one dose of study medication.
Frequency Threshold: 0
Time Frame: Serious adverse events (SAEs) and non-serious AEs were collected from Day 1 of Treatment Period 1 until Follow-up visit (up to 10 weeks)
Study: NCT00515502
Study Brief: Safety Study Using GSK573719 And Tiotropium In Patients With Chronic Obstructive Pulmonary Disease
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 a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days. None None 0 21 6 21 View
UMEC 250 µg Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days. None None 0 22 9 22 View
UMEC 500 µg Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days. None None 0 21 8 21 View
UMEC 1000 µg Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days. None None 0 13 4 13 View
Tiotropium 18 µg Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days. None None 0 8 3 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Tension headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Infected insect bite SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gingivitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Tooth loss SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Gammopathy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View