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 @ 12:04 AM
Ignite Modification Date: 2025-12-25 @ 10:02 PM
NCT ID: NCT03174158
Description: Adverse event data was collected at each outcome assessment
Frequency Threshold: 0
Time Frame: 12 weeks
Study: NCT03174158
Study Brief: A Text Messaging Program for Smokers in Primary Care
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Brief Advice Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training 0 None 0 39 0 39 View
Text Messaging Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources. Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training 0 None 0 39 0 39 View
Mailed Nicotine Replacement Therapy Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges. Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training 0 None 0 36 14 36 View
Text Messaging + Mailed NRT Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges. Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources. Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training 0 None 0 39 7 39 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anxiety or agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
mouth soreness NON_SYSTEMATIC_ASSESSMENT General disorders None View
sleep disturbance NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
lightheadedness NON_SYSTEMATIC_ASSESSMENT General disorders None View
skin irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
bloating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
None NON_SYSTEMATIC_ASSESSMENT General disorders None View