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: 2025-12-25 @ 2:32 AM
Ignite Modification Date: 2025-12-26 @ 1:08 AM
NCT ID: NCT01842334
Description: None
Frequency Threshold: 5
Time Frame: Adverse even data was collected from the baseline visit until the end of the study (14 weeks after baseline)
Study: NCT01842334
Study Brief: D-cycloserine (DCS) Pretreatment + CBT + Nicotine Replacement Therapy for Smoking Cessation (DCS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
D-cycloserine 250 mg D-cycloserine once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy. Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group. Nicotine Replacement Therapy: NRT administered to both DCS and placebo group. 0 None 0 5 1 5 View
Placebo one placebo capsule once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group. Nicotine Replacement Therapy: NRT administered to both DCS and placebo group. 0 None 0 7 0 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea due to Nicotine Patch SYSTEMATIC_ASSESSMENT General disorders None View