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 @ 4:18 AM
Ignite Modification Date: 2025-12-26 @ 3:19 AM
NCT ID: NCT05789420
Description: Adverse Events were collected for all subjects who gave informed consent and had at least one safety assessment, which included all screened (32 subjects), enrolled (31 subjects), and randomized (30 subjects).
Frequency Threshold: 5
Time Frame: Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 34 days.
Study: NCT05789420
Study Brief: Nicotine Pharmacokinetics of THS Single Use of a Regular or a Menthol Stick Compared to CIG
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Safety Population The safety population consisted of all subjects (screened \[32 subjects\], enrolled \[31 subjects\], and randomized \[30 subjects\]) who gave informed consent and had at least one safety assessment. 0 None 0 32 0 32 View
Serious Events(If Any):
Other Events(If Any):