Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:55 AM
Ignite Modification Date: 2025-12-26 @ 1:36 AM
NCT ID: NCT01656733
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data was collected from baseline visit up to delivery of infant.
Study: NCT01656733
Study Brief: Nicotine Replacement for Smoking Cessation During Pregnancy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Inhaler Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Nicotrol Inhaler: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper. 0 None 40 67 0 67 View
Nicotrol Inhaler Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper. Nicotrol Inhaler: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper. 0 None 28 70 12 70 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infant Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Low Birth Weigh (<2500 grams) SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Preterm delivery SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Spontaneous Abortion SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Perinatal Mortality SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Neonatal Abstinence Syndrome SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Maternal Hospitalizationfor Medical Condition SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Fetal Cardiac Anomaly SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Right Club Foot SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Infant Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Infant Low Blood Sugar SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bad taste SYSTEMATIC_ASSESSMENT General disorders None View
Increased mucus in throat SYSTEMATIC_ASSESSMENT General disorders None View