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 @ 4:36 PM
Ignite Modification Date: 2025-12-25 @ 2:27 PM
NCT ID: NCT03880266
Description: All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
Frequency Threshold: 0
Time Frame: Baseline through Week 2
Study: NCT03880266
Study Brief: A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1 Active Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove) 0 None 0 12 5 12 View
Group 1 Vehicle Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove) 0 None 0 6 2 6 View
Group 2 Active Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove) 0 None 0 12 5 12 View
Group 2 Vehicle Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove) 0 None 0 4 1 4 View
Group 3 Active Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes 0 None 0 12 1 12 View
Group 3 Vehicle Vehicle cloth applied to the hands once daily for 14 days: 15 minutes 0 None 0 6 2 6 View
Group 4 Active Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes 0 None 0 13 2 13 View
Group 4 Vehicle Vehicle cloth applied to the hands once daily for 14 days: 30 minutes 0 None 0 7 0 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.1) View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.1) View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.1) View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.1) View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.1) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.1) View
Compensatory sweating SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.1) View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.1) View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (21.1) View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (21.1) View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.1) View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.1) View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.1) View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.1) View
Application site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.1) View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.1) View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.1) View