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 @ 6:31 PM
Ignite Modification Date: 2025-12-25 @ 4:01 PM
NCT ID: NCT05459857
Description: None
Frequency Threshold: 0
Time Frame: From screening until follow-up (7 days after the final product use)
Study: NCT05459857
Study Brief: A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco Products Compared to Combustible Cigarettes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Product D Subjects using Product D (subject's own brand combustible cigarette) for one product use session, under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration) 0 None 0 23 0 23 View
Product A Subjects using Product A (Heated Tobacco device Intense), for one product use session, under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration) 0 None 0 24 2 24 View
Product B Subjects using Product B (Heated tobacco device Regular), for one product use session, under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration) 0 None 0 24 3 24 View
Product C Subjects using Product C (Heated tobacco device menthol), for one product use session, under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration) 0 None 0 24 1 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Catheter site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (24.1) View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (24.1) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (24.1) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (24.1) View