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 @ 2:30 AM
Ignite Modification Date: 2025-12-26 @ 1:05 AM
NCT ID: NCT02433834
Description: Safety Population includes all subjects who were randomized to treatment and received at least one dose of study treatment
Frequency Threshold: 5
Time Frame: Adverse events captured from Day 1 through Final Follow up Visit, which is 7-14 days post last study drug dose, unless serious. If serious, they are captured from screening Visit 1 through Final Follow up Visit
Study: NCT02433834
Study Brief: Chronic Dosing Cross-Over Study to Assess the Efficacy and Safety of Glycopyrronium (PT001) in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent Asthma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GP MDI 28.8 µg Glycopyrronium Metered Dose Inhaler (GP MDI) 28.8 µg None None 0 112 9 112 View
GP MDI 14.4 µg Glycopyrronium Metered Dose Inhaler (GP MDI) 14.4 µg None None 0 230 15 230 View
GP MDI 3.6 µg Glycopyrronium Metered Dose Inhaler (GP MDI) 3.6 µg None None 0 118 8 118 View
GP MDI 1.9 µg Glycopyrronium Metered Dose Inhaler (GP MDI) 1.9 µg None None 0 107 8 107 View
Placebo MDI Placebo MDI. None None 1 174 13 174 View
SAL 50 µg salmeterol 50 µg None None 0 167 9 167 View
GP MDI 7.2 µg Glycopyrronium Metered Dose Inhaler (GP MDI) 7.2 µg None None 0 228 16 228 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenteritis, viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View