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: 2025-12-24 @ 9:11 PM
Ignite Modification Date: 2025-12-25 @ 7:01 PM
NCT ID: NCT00773604
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00773604
Study Brief: Deep Brain Stimulation in Patients With Dystonia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment DBS treatment patients 0 None 0 9 9 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depression, transient worsening SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Weight gain NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anxiety, worsened SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysphasia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Transient erythema around parietal incision site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Subgaleal cerebral fluid collection around burr-hole cap NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Persistent pain at IPG site NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Shock-like sensations NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Migraine headaches, worsened NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sensory deficit in hand, worsened SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lower extremity paresthesias SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Blood pressure instability SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Knee dislocation NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Knee injury NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hip pain, worsened NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fourth cranial nerve palsy, preexisting NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Handwriting difficulties NON_SYSTEMATIC_ASSESSMENT General disorders None View
Humming sounds in ear, worsened NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View