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 @ 2:23 PM
Ignite Modification Date: 2025-12-25 @ 12:59 PM
NCT ID: NCT02188459
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data were collected from the time subjects received their first dose of study medication until the end of the 10-week treatment period or, if the adverse event was present at 10 weeks, until it resolved, up to 20 weeks.
Study: NCT02188459
Study Brief: Placebo-controlled Trial of Bupropion for Smoking Cessation in 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
Bupropion Bupropion 150 mg BID, PO for 10 weeks 0 None 2 64 41 64 View
Placebo Placebo BID, PO for 10 weeks. 0 None 3 65 40 65 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Spontaneous delivery with Hospitalization SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Vasa previa SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Stillbirth with Nuchal Cord SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Still birth SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT General disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Irritability NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sleep problem NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Depressed Mood NON_SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View