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 @ 4:34 PM
Ignite Modification Date: 2025-12-25 @ 2:26 PM
NCT ID: NCT02737566
Description: None
Frequency Threshold: 0
Time Frame: 27 weeks (1 week pre-quit-date through 26 weeks post-quit-date)
Study: NCT02737566
Study Brief: Small Financial Incentives to Promote Smoking Cessation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard Care + Financial Incentives Participants randomized to Standard Care + Financial Incentives for Abstinence will be offered smoking cessation counseling and pharmacotherapy (standard care) and they will have the opportunity to earn small gift cards for biochemically-verified abstinence through 12 weeks post-quit. The amount of the gift cards will escalate each week from the quit date through 4 weeks post-quit with continuous abstinence. Participants who are non-abstinent at any visit may earn incentives for abstinence at the next visit, but the amount will reset to the starting level. Participants may additionally earn an additional gift card for abstinence at the 8 and 12 weeks post-quit visits. Standard Care + Financial Incentives: Tobacco cessation counseling plus pharmacotherapy and financial incentives for quitting. 0 None 0 159 2 159 View
Standard Care Participants randomized to Standard Care will be offered weekly smoking cessation counseling and pharmacotherapy. Standard Care: Tobacco cessation counseling plus pharmacotherapy. 0 None 0 161 2 161 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood in Urine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Dissatisfaction with compensation NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Study smartphone was stolen NON_SYSTEMATIC_ASSESSMENT Social circumstances None View