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 @ 7:44 PM
Ignite Modification Date: 2025-12-25 @ 5:22 PM
NCT ID: NCT03178903
Description: It does not differ from clinicaltrials.gov definitions
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT03178903
Study Brief: tDCS for Increasing Exercise Adherence in Depressed Individuals
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
tDCS and Aerobic Exercise Each participant will undergo a 20-minute session of transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks. tDCS: Participants in transcranial direct current stimulation (tDCS) will receive tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks. Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks. 0 None 4 25 2 25 View
Sham tDCS and Aerobic Exercise Each participant will undergo a 20-minute session of sham transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks. Sham tDCS: Participants in sham transcranial direct current stimulation (tDCS) will receive shame tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks. Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks. 0 None 0 26 1 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Psychiatric Inpatient Hospitalization NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Medical Hospitalization NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Medical Hospitalization NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Medical Hospitalization NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
knee injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View