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 @ 9:24 PM
Ignite Modification Date: 2025-12-25 @ 7:10 PM
NCT ID: NCT02210832
Description: We report the number of instances of pregnancy termination/fetal demise per treatment condition.
Frequency Threshold: 0
Time Frame: On average women were followed for 1 year, 6 months (end of 1st trimester of pregnancy through 1 year postpartum).
Study: NCT02210832
Study Brief: Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant Women
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Best Practices for Pregnant Smokers Five As plus referral to pregnancy-specific tobacco quit line Best practices 0 None 3 91 0 91 View
Best Practices Plus Financial Incentives Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum. Best practices financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence 0 None 4 85 0 85 View
Never-smoker Comparison Condition We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum 0 None 1 81 0 81 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pregnancy termination/fetal demise SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other Events(If Any):