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 @ 9:47 PM
Ignite Modification Date: 2025-12-25 @ 7:26 PM
NCT ID: NCT01959932
Description: The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
Frequency Threshold: 5
Time Frame: From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
Study: NCT01959932
Study Brief: Reduced Exposure Study in Smokers Using THS 2.2 With 5 Days in a Confinement Setting.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tobacco Heating System (THS 2.2) Ad libitum use of THS 2.2 for 5 days in confinement None None 0 80 44 80 View
Smoking Abstinence (SA) Abstinence from smoking for 5 days in confinement None None 0 39 22 39 View
Conventional Cigarette (CC) Ad libitum use of subject's own preferred brand of CC for 5 days in confinement None None 0 41 26 41 View
Enrolled But Not Randomized Subjects who tried the THS 2.2 at Admission (Day -2) but were not randomized in 1 of the 3 arms as they were back-up subjects None None 0 9 9 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View
Spirometry abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (16.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.0) View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.0) View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.0) View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (16.0) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (16.0) View
Polyuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (16.0) View
Hypertriglyceridaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (16.0) View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (16.0) View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (16.0) View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (16.0) View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (16.0) View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (16.0) View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (16.0) View
Ventricular extrasystoles NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (16.0) View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (16.0) View
Lymphocyte count increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (16.0) View