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 @ 12:32 AM
Ignite Modification Date: 2025-12-25 @ 10:40 PM
NCT ID: NCT03075267
Description: The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
Frequency Threshold: 5
Time Frame: Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
Study: NCT03075267
Study Brief: Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PT010 (BGF MDI) 320/14.4/9.6 µg PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg 0 None 0 32 14 32 View
PT003 (GFF MDI) 14.4/9.6 µg PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg 0 None 0 32 14 32 View
PT010 (BGF MDI) 160/14.4/9.6 µg PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg 0 None 0 32 11 32 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood potassium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Bilirubin conjugated increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood glucose decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Dry throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sensation of foreign body SYSTEMATIC_ASSESSMENT General disorders MedDRA View