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 @ 2:19 PM
Ignite Modification Date: 2025-12-25 @ 12:56 PM
NCT ID: NCT05317195
Description: Note that the "Safety Population (NP-1)" comprised 31 subjects who were enrolled in the study and performed a product test with NP-1 at admission. Following the product test, 24 subjects were randomized to product use.
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 27 days.
Study: NCT05317195
Study Brief: Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers
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 (NP-2) Comprised all enrolled subjects who were exposed to NP-2 during the study. 0 None 0 22 0 22 View
Safety Population (NP-3) Comprised all enrolled subjects who were exposed to NP-3 during the study. 0 None 0 22 0 22 View
Safety Population (NP-4) Comprised all enrolled subjects who were exposed to NP-4 during the study. 0 None 0 22 0 22 View
Safety Population (Velo-NP) Comprised all enrolled subjects who were exposed to Velo-NP during the study. 0 None 0 23 0 23 View
Safety Population (Zyn-NP) Comprised all enrolled subjects who were exposed to Zyn-NP during the study. 0 None 0 24 0 24 View
Safety Population (NP-1 Test) Comprised all enrolled subjects who, on Day -1, performed a product test using NP-1 for 30 minutes (± 1 minute). 0 None 0 31 0 31 View
Safety Population (NP-1) Comprised all enrolled subjects who were exposed to NP-1 during the study. 0 None 0 22 0 22 View
Serious Events(If Any):
Other Events(If Any):