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 @ 2:54 AM
Ignite Modification Date: 2025-12-26 @ 1:35 AM
NCT ID: NCT03635333
Description: None
Frequency Threshold: 1
Time Frame: Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.
Study: NCT03635333
Study Brief: Effects of E-Cigarette Flavors on Adults TCORS 2.0
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vanilla Low Nicotine Group (6mg/ml) Participants who were assigned to the low nicotine condition and were exposed to vanilla flavor. 0 None 0 55 0 55 View
Vanilla High Nicotine Group (18mg/ml) Participants who were assigned to the high nicotine condition and were exposed to vanilla flavor. 0 None 0 52 0 52 View
Cherry Low Nicotine Group (6mg/ml) Participants who were assigned to the low nicotine condition and were exposed to cherry flavor. 0 None 0 51 1 51 View
Tobacco Low Nicotine Group (6mg/ml) Participants who were assigned to the low nicotine condition and were exposed to tobacco flavor. 0 None 0 59 1 59 View
Tobacco High Nicotine Group (18mg/ml) Participants who were assigned to the high nicotine condition and were exposed to tobacco flavor. 0 None 0 57 0 57 View
Menthol Low Nicotine Group (6mg/ml) Participants who were assigned to the low nicotine condition and were exposed to menthol flavor. 0 None 0 59 0 59 View
Menthol High Nicotine Group (18mg/ml) Participants who were assigned to the high nicotine condition and were exposed to menthol flavor. 0 None 0 56 0 56 View
Randomized Non-Starter Low Nicotine Group (6mg/ml) Participants who were randomized to the low nicotine condition and enrolled in the trial but did not start lab and thus had no flavor exposure 0 None 0 8 0 8 View
Randomized Non-starter High Nicotine Group (18mg/ml) Participants who were randomized to the high nicotine condition and enrolled in the trial but did not start lab and thus had no flavor exposure 0 None 0 6 0 6 View
Cherry High Nicotine Group (18mg/ml) Participants who were assigned to the high nicotine condition and were exposed to cherry flavor. 0 None 0 51 0 51 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Other NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View