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 @ 2:16 AM
Ignite Modification Date: 2025-12-26 @ 12:45 AM
NCT ID: NCT02691260
Description: Adverse events were also collected during in-person visits
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT02691260
Study Brief: Incentivizing Behavior Change Skills to Promote Weight Loss
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Incentives for Both Participants receive incentives for dietary self-monitoring and interim weight loss. incentives for both: Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application and for losing an expected amount of weight based on weight obtained weekly. 0 None 0 26 1 26 View
Incentives for Interim Weight Loss Participants receive financial incentives for interim weight loss. incentives for interim weight loss: Participants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly. 0 None 0 27 5 27 View
no Incentives Participants do not receive financial incentives. 0 None 1 26 3 26 View
Incentives for Dietary Self-monitoring Participants receive financial incentives for dietary self-monitoring. incentives for dietary self-monitoring: Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application. 0 None 0 26 3 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Generally unwell NON_SYSTEMATIC_ASSESSMENT General disorders None View
Gout like symptoms NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
ER visit for allergies NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
irritated diverticulitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Planned foot surgery NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Bone achiness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
High blood pressure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
blood in urine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
erythema NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Swollen lymph node NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dog bite NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View