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 @ 9:49 PM
Ignite Modification Date: 2025-12-25 @ 7:27 PM
NCT ID: NCT02920632
Description: No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
Frequency Threshold: 0
Time Frame: 2 years (duration of study)
Study: NCT02920632
Study Brief: Cognitive Training in Parkinson Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Online Cognitive Training 1 (N=68) Eight-week, three times a week during 45 minutes cognitive training Online cognitive training 1: Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions. 0 None 0 68 9 68 View
Online Cognitive Training 2 (N=68) Eight-week, three times a week during 45 minutes cognitive activities Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games. 0 None 1 68 10 68 View
Healthy Control Subjects (N=31) Reference group to compare cognitive training effects to 0 None 0 31 0 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Impulse control disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Medical issue other than PD: injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Medical issue other than PD: dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Medical issue related to PD NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Training-related adverse event NON_SYSTEMATIC_ASSESSMENT General disorders None View
Medical issue not PD-related: COVID NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Medical issue other than PD: Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Medical issue other than PD: meningioma NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Medical issue other than PD: cerebral infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Medical issue other than PD: Restless legs and hyperventilation NON_SYSTEMATIC_ASSESSMENT General disorders None View