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 @ 3:04 PM
Ignite Modification Date: 2025-12-25 @ 1:26 PM
NCT ID: NCT02549859
Description: AE and SAE were defined by the investigator as any medical event that the patient and doctor considered medically relevant.
Frequency Threshold: 0
Time Frame: Data on adverse events were collected beginning from the time of consent and extending until all study procedures were complete for the patient, an average of 14.5 months. After patient's second visit was completed, no further AEs were collected.
Study: NCT02549859
Study Brief: Long-term Effect of Low Frequency Stimulation on Aspiration and Freezing of Gait in PD With STN DBS
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DBS 60Hz Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition. 0 None 0 11 0 11 View
DBS 130Hz Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition. 0 None 0 11 0 11 View
DBS Off Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition. 0 None 0 11 0 11 View
Serious Events(If Any):
Other Events(If Any):