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 @ 2:16 AM
Ignite Modification Date: 2025-12-26 @ 12:46 AM
NCT ID: NCT02129660
Description: The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
Frequency Threshold: 5
Time Frame: 6 weeks
Study: NCT02129660
Study Brief: Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary 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
Dose 1 of Glycopyrrolate Dose 1 of glycopyrrolate Topical Wipes 0 None 0 21 4 21 View
Dose 2 of Glycopyrrolate Dose 2 of glycopyrrolate Topical Wipes 0 None 0 20 8 20 View
Dose 1 of Glycopyrronium Dose 1 of glycopyrronium Topical Wipes 0 None 0 22 11 22 View
Dose 2 of Glycopyrronium Dose 2 of glycopyrronium Topical Wipes 0 None 0 20 10 20 View
Vehicle Vehicle Topical Wipes 0 None 0 21 6 21 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mydriasis SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Application Site Pain SYSTEMATIC_ASSESSMENT General disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nasal dryness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Accidental Exposure to Product SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Decrease Appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Drug Interaction SYSTEMATIC_ASSESSMENT General disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Excoriation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypohidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Injection Site Bruising SYSTEMATIC_ASSESSMENT General disorders None View
Ligament Sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ocular Hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tongue disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders None View