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 @ 9:44 PM
Ignite Modification Date: 2025-12-25 @ 7:24 PM
NCT ID: NCT04132232
Description: As this is a low-risk study, an independent data safety monitoring board will not be formed. We defined an adverse event as an undesirable experience or outcome occurring in a research participant, regardless of whether participation in the research study caused the event to occur. For example, placental abruption and/or stillbirth are known risks of pregnancy, and while not associated with the Smokerlyzer® device, would be considered an adverse event if it occurred during the study.
Frequency Threshold: 0
Time Frame: Over the course of the study period, which is around 10 months per participant.
Study: NCT04132232
Study Brief: Smoking Reduction In Gravid Substance Use Disorders
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Group 1. The patient will exhaled into the Smokerlyzer® device will at each visit 2. Exhaled carbon monoxide and fetal carboxyhemoglobin levels will be disclosed to the patient 3. Risks of adverse perinatal outcomes related to maternal carboxyhemoglobin and fetal carboxyhemoglobin level will be provided. knowledge of expired maternal carbon monoxide and fetal carboxyhemoglobin levels: Will use the Smokerlyzer® device at each visit and be provided information on exhaled carbon monoxide and fetal carboxyhemoglobin. Risks of adverse perinatal outcomes related to maternal carbon monoxide and fetal carboxyhemoglobin level will be provided. 0 None 0 37 0 37 View
Control Group 1. The patient will exhale into the Smokerlyzer® device at each visit. 2. Exhaled carbon monoxide and fetal carboxyhemoglobin level will NOT be disclosed to the patient 3. No risks of adverse perinatal outcomes related to maternal carbon monoxide and fetal carboxyhemoglobin levels will be provided 0 None 0 37 0 37 View
Serious Events(If Any):
Other Events(If Any):