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 @ 4:59 AM
Ignite Modification Date: 2025-12-26 @ 3:59 AM
NCT ID: NCT03808818
Description: Adverse events were only reportable for subjects on the Virtual Intervention arm of the study (ie., those with the possibility of being recommended Nicotine Replacement Therapy from the study team)
Frequency Threshold: 5
Time Frame: from randomization up to 1 year
Study: NCT03808818
Study Brief: Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral) Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline. Behavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies 13 None 13 150 0 150 View
Virtual Counseling (Virtual Counseling Sessions, NRT) Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone). Nicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling 10 None 10 156 0 156 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death, NOS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE4.0 View
Other NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE4.0 View
Disease progression NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE4.0 View
Cardiac Arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE4.0 View
Other Events(If Any):