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 @ 1:10 AM
Ignite Modification Date: 2025-12-25 @ 11:21 PM
NCT ID: NCT02685293
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from screening, throughout the treatment periods until the follow-up visit 14±2 days from the last study treatment administration. Overall timeframe of up to a maximum of 12 weeks.
Study: NCT02685293
Study Brief: Study to Evaluate the Treatment Effect of PT003 on Cardiovascular Hemodynamics 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 GFF MDI (PT003) 14.4/9.6 μg was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2. 0 None 0 4 0 4 View
Placebo Placebo MDI was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2. 0 None 0 4 1 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View