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 @ 9:28 PM
Ignite Modification Date: 2025-12-25 @ 7:14 PM
NCT ID: NCT01653132
Description: all subjects were asked at each monthly visit if they had experienced any adverse events since the previous visit. If they responded yes, a checklist of common and rare side effects was used to query subjects, their adverse events were recorded in a standardized fashion and reported to the Committee for Clinical Investigations as per regulations
Frequency Threshold: 0
Time Frame: Adverse events data were collected for each subject at monthly visits for the duration of the study, 7-8 months per subject
Study: NCT01653132
Study Brief: Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Incobotulinum Toxin Incobotulinum Toxin 100 units diluted in 1 ml of sterile 0.9% saline injected in the parotid (20 units, 0.2 ml each) and submandibular (30 units, 0.3ml each) glands of subjects None None 0 9 2 9 View
Placebo Sterile, preservative free 0.9% saline, 1 mL injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands . None None 0 10 0 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
chewing difficulty NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
viscous saliva NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View