Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:32 AM
Ignite Modification Date: 2025-12-26 @ 1:08 AM
NCT ID: NCT04201834
Description: Our definitions of adverse events and serious adverse events is consistence with the definitions that are provided by clinicaltrials.gov. The recording of adverse events began once the participant signed informed consent and continued until the participant completed the study or withdrew from participation.
Frequency Threshold: 5
Time Frame: 12 weeks
Study: NCT04201834
Study Brief: Risperidone for the Treatment of Huntington's Disease Involuntary Movements
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Risperidone Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached. Risperidone: capsule or tablet, 0.5 mg BioStamp nPoint device: MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection. 0 None 0 5 5 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperemia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Constant throat clearing SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Jerky movements - hands, arms, shoulders SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Prolonged QTc Interval SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tics SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View