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: 2025-12-24 @ 3:04 PM
Ignite Modification Date: 2025-12-25 @ 1:26 PM
NCT ID: NCT02454959
Description: Any Adverse Events reported as starting during a Washout Period were assigned to the last randomized treatment received including those occurring during a Washout Period or the Follow-up Period. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
Frequency Threshold: 2
Time Frame: Adverse events collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
Study: NCT02454959
Study Brief: Crossover Study to Assess the Efficacy of PT003 With and Without a Valved Holding Chamber in Subjects With Moderate to Severe 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
GFF MDI (PT003) With Aerochamber Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber None None 1 74 3 74 View
GFF MDI (PT003) Without Aerochamber Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber None None 2 78 8 78 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood potassium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vessel puncture site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View