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: 2025-12-26 @ 2:43 PM
Ignite Modification Date: 2025-12-26 @ 2:43 PM
NCT ID: NCT01967706
Description: The safety was assessed in the safety population, consisting of 73 subjects: 62 randomized subjects (44 in Group 1, 18 in Group 2) and 11 subjects exposed to mTHS and NRT from the product trials on Day -1 but not randomized.
Frequency Threshold: 5
Time Frame: From informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
Study: NCT01967706
Study Brief: Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol).
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1 This population comprised the subjects that followed these intervention sequences: * Sequence "mTHS then mCC" * Sequence "mCC then mTHS" None None 0 44 0 44 View
Group 2 This population comprised the subjects that followed these intervention sequences: * Sequence "mTHS then NRT" * Sequence "NRT then mTHS" None None 0 18 1 18 View
Enrolled But Not Randomized Subjects who tried the mTHS at Admission (Day -1) but were not randomized in 1 of the 2 groups as they were back-up subjects None None 0 11 0 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (16.0) View