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: 2025-12-25 @ 5:03 AM
Ignite Modification Date: 2025-12-26 @ 4:04 AM
NCT ID: NCT03572218
Description: At each contact with participants, study personnel non-systematically collected information on any adverse events (AEs) self-reported by participants. In addition, AEs were systematically assessed at the scheduled assessments. AEs were documented by study staff in consultation with a nurse practitioner and/or physician. Serious adverse events (SAEs) were reported immediately to the study sponsor, Data and Safety Monitor, and the Institutional Review Board.
Frequency Threshold: 5
Time Frame: Week 1 through week 26
Study: NCT03572218
Study Brief: Psychological Intervention to Reduce Weight Bias Internalization
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BWL + BIAS In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. 0 None 0 36 3 36 View
Standard BWL In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. 0 None 1 36 7 36 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Viral gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asthma exacerbation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Knee pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View