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 @ 12:52 AM
Ignite Modification Date: 2025-12-25 @ 11:07 PM
NCT ID: NCT01188967
Description: Adverse events were recorded for all subjects at weekly sessions.
Frequency Threshold: 0
Time Frame: Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up).
Study: NCT01188967
Study Brief: Effectiveness of GSK598809, a Selective D3 Antagonist, Added to CBT and NRT for Smoking Cessation and Relapse Prevention
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GSK598809 Treatment Group There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received the GSK598809 pills, the active treatment. None None 1 10 6 10 View
Placebo Treatment Group There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received the placebo pills. None None 0 8 4 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leg Cramps SYSTEMATIC_ASSESSMENT General disorders None View
Tiredness SYSTEMATIC_ASSESSMENT General disorders None View
Fungal Skin Infection SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Peripheral Vascular Disease SYSTEMATIC_ASSESSMENT General disorders None View
Weight Gain SYSTEMATIC_ASSESSMENT General disorders None View
Dry Tongue SYSTEMATIC_ASSESSMENT General disorders None View
Numbness of Tongue SYSTEMATIC_ASSESSMENT General disorders None View
Chest Tightness SYSTEMATIC_ASSESSMENT General disorders None View
Eczema Flame SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
URI SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cold SYSTEMATIC_ASSESSMENT General disorders None View