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:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 12:47 AM
NCT ID:
NCT05426460
Description:
None
Frequency Threshold:
1
Time Frame:
Tracking of adverse occurred over 2 years, 1 month
Study:
NCT05426460
Study Brief:
AAT + tDCS to Reduce Cue-induced Craving and Smoking Behavior
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| AAT + tDCS | Approach Avoidance Task + Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex Approach/Avoidance Task: The Approach/avoidance task (AAT) training is done using a joystick. The AAT tasks involves having participants push away pictures of smoking stimuli that appear on the screen by pushing the joystick forward, and pulling in pictures of nonsmoking stimuli that appear on the screen by pulling the joystick towards themselves. Pushing smoking-related pictures away causes the picture to shrink in size, whereas pulling a picture closer causes the picture to increase in size. This task consists of 4 blocks of 24 pictures, taking 30 minutes. Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation active (2.0 mA) (tDCS) will be used to temporarily increase cortical excitability of the dorsolateral prefrontal cortex (dlPFC) in healthy daily smokers. Participants assigned to active tDCS conditions will receive active (2.0 mA) tDCS, with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. tDCS will be administered the first 20 minutes of each of the five 30 minute AAT training sessions. | 0 | None | 0 | 11 | 0 | 11 | View |
| AAT + Sham tDCS | Approach Avoidance Task with Sham Transcranial Direct Current Stimulation. Approach/Avoidance Task: The Approach/avoidance task (AAT) training is done using a joystick. The AAT tasks involves having participants push away pictures of smoking stimuli that appear on the screen by pushing the joystick forward, and pulling in pictures of nonsmoking stimuli that appear on the screen by pulling the joystick towards themselves. Pushing smoking-related pictures away causes the picture to shrink in size, whereas pulling a picture closer causes the picture to increase in size. This task consists of 4 blocks of 24 pictures, taking 30 minutes. Sham tDCS: Sham transcranial Direct Current Stimulation (0.1 mA) (sham tDCS) will be used as a control for active tDCS with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. Sham tDCS will be administered during the first 20 minutes of each of the four blocks of 24 pictures, taking 30 minutes, across the 5 training sessions. | 0 | None | 0 | 9 | 0 | 9 | View |
| AC + tDCS | Active Control Task with Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation active (2.0 mA) (tDCS) will be used to temporarily increase cortical excitability of the dorsolateral prefrontal cortex (dlPFC) in healthy daily smokers. Participants assigned to active tDCS conditions will receive active (2.0 mA) tDCS, with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. tDCS will be administered the first 20 minutes of each of the five 30 minute AAT training sessions. AC: During Active Control (AC) participants press a button on the left of right of the joystick to indicate the position the picture on a screen. Position of pictures will be balanced across the 4 blocks of 24 pictures, taking 30 minutes. | 0 | None | 0 | 11 | 0 | 11 | View |
| AC + Sham tDCS | Active Control Task with sham Transcranial Direct Current Stimulation AC: During Active Control (AC) participants press a button on the left of right of the joystick to indicate the position the picture on a screen. Position of pictures will be balanced across the 4 blocks of 24 pictures, taking 30 minutes. Sham tDCS: Sham transcranial Direct Current Stimulation (0.1 mA) (sham tDCS) will be used as a control for active tDCS with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. Sham tDCS will be administered during the first 20 minutes of each of the four blocks of 24 pictures, taking 30 minutes, across the 5 training sessions. | 0 | None | 0 | 8 | 0 | 8 | View |
Serious Events(If Any):
Other Events(If Any):