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 @ 7:37 PM
Ignite Modification Date: 2025-12-25 @ 5:17 PM
NCT ID: NCT02977403
Description: None
Frequency Threshold: 0
Time Frame: 2 weeks
Study: NCT02977403
Study Brief: Mobile Attention Retraining in Overweight Female Adolescents
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AB Retraining Active treatment - the probe always replaces the neutral picture. There is a perfect correlation between picture type and probe location. Attention Bias Retraining: Attention retraining program on smartphone where the probe always replaces the neutral picture. There is a perfect correlation between picture type and probe location. 0 None 0 32 4 32 View
Control Sham Sham Comparator program - the probe randomly replaces the neutral or food picture. There is no correlation between picture type and probe location Sham Comparator: AB Control: Sham Comparator "training" where the probe randomly replaces the neutral or food pictures. There is no correlation between picture type and probe location 0 None 0 36 2 36 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Neck Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View