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 @ 9:40 PM
Ignite Modification Date: 2025-12-25 @ 7:22 PM
NCT ID: NCT02147132
Description: None
Frequency Threshold: 0
Time Frame: 8 weeks
Study: NCT02147132
Study Brief: Pilot Study of Nicotine Nasal Spray and Varenicline on Smoking in Methadone-Maintained Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nicotine Nasal Spray All participants who received the nicotine nasal spray 0 None 0 7 4 7 View
Placebo Nasal Spray All participants who received the placebo nasal spray 0 None 0 7 1 7 View
Varenicline Tablets All participants who received the active varenicline tablets 0 None 0 6 2 6 View
Placebo Varenicline Tablets All participants who received the placebo varenicline tablets 0 None 0 6 0 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
bloodshot eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
ear ache SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
flu-like symptoms SYSTEMATIC_ASSESSMENT General disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hot / cold flashes SYSTEMATIC_ASSESSMENT Vascular disorders None View
difficulty hearing in right ear SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
menstrual cramps SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View