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 @ 8:03 PM
Ignite Modification Date: 2025-12-25 @ 5:36 PM
NCT ID: NCT02468804
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02468804
Study Brief: Cognitive Dysfunction In Parkinson's
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Parkinson's Disease Subjects Participants performed a working memory task during MEG recording. Then PD subjects were randomized to receive a course of either real (rTMS) or sham TMS on a separate day (max 1 week after first MEG). 20 min after TMS subjects again performed the same working memory task while having MEG data recorded REAL: Repetitive TMS was delivered at 20 Hz at 90% of the subjects resting motor threshold (RMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere. SHAM: stimulation was delivered with the same TMS parameters as active simulation but the coil held at 90 degree to the scalp to induce similar somatic sensations and noise as in the active group with minimal brain effects. 0 None 0 36 1 36 View
Control Subjects Participants performed a working memory task during MEG recording. Then control subjects were randomized to receive a course of either real (rTMS) or sham TMS on a separate day (max 1 week after first MEG). 20 min after TMS subjects again performed the same working memory task while having MEG data recorded. REAL: Repetitive TMS was delivered at 20 Hz at 90% of the subjects resting motor threshold (RMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere. SHAM: stimulation was delivered with the same TMS parameters as active simulation but the coil held at 90 degree to the scalp to induce similar somatic sensations and noise as in the active group with minimal brain effects. 0 None 0 50 0 50 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View