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 @ 3:43 PM
Ignite Modification Date: 2025-12-24 @ 3:43 PM
NCT ID: NCT03830892
Description: Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants. All adverse events occurred in between study sessions (i.e., while participants were not receiving the intervention). Because effects of interventions end as soon as the intervention ends, adverse events occurring in between sessions are not related to the intervention and data about prior nor current session details was not stored with adverse events data.
Frequency Threshold: 5
Time Frame: Data were collected during laboratory visits, approximately over 3 weeks; no follow up data collection occurred.
Study: NCT03830892
Study Brief: Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
E-cigarette User (Exclusive) Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power 0 None 1 19 3 19 View
Dual User Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power Own Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power 0 None 0 13 7 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Worsening cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shortness of breath NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View