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 @ 6:59 PM
Ignite Modification Date: 2025-12-25 @ 4:32 PM
NCT ID: NCT00773357
Description: None
Frequency Threshold: 0
Time Frame: Titration period of 21 days
Study: NCT00773357
Study Brief: Modeling Stress-precipitated Smoking Behavior for Medication Development
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 placebo control placebo: placebo 0 None 0 50 12 50 View
Guanfacine guanfacine 3mg/day guanfacine: 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study. 0 None 0 50 35 50 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
dry mouth SYSTEMATIC_ASSESSMENT General disorders None View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Impotence SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View