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 @ 11:40 PM
Ignite Modification Date: 2025-12-25 @ 9:31 PM
NCT ID: NCT03364751
Description: The safety population comprised the 179 subjects enrolled in the study, of which 172 subjects were randomized to the IQOS or Cigarette arms. Adverse events are reported according to subjects' product exposure over the study period (Product Use Category, i.e., IQOS use; Cigarette use; Dual use; or Other use) as detailed in the "Arm/Group" (Reporting Groups) table. The seven subjects who were enrolled but not randomized are included in the Cigarette group for adverse event reporting.
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, for a total study duration of up to 31 weeks for each subject.
Study: NCT03364751
Study Brief: Effect of Switching From Cigarette Smoking to the Use of IQOS on Periodontitis Treatment Outcome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
IQOS IQOS users (safety population) 0 None 0 70 25 70 View
Cigarette Cigarette users (safety population; includes 7 subjects who were enrolled but not randomized and were considered to be in the cigarette users group) 0 None 2 91 29 91 View
Dual Dual users (safety population) 0 None 0 17 13 17 View
Other Other users (safety population) 0 None 0 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.0) View
Jaw cyst NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dental caries NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.0) View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.0) View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.0) View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.0) View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.0) View
Tooth fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (20.0) View
Procedural Pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (20.0) View
Gout NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (20.0) View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.0) View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.0) View
Oral papilloma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (20.0) View
Hyperaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (20.0) View
Device breakage NON_SYSTEMATIC_ASSESSMENT Product Issues MedDRA (20.0) View
Device failure NON_SYSTEMATIC_ASSESSMENT Product Issues MedDRA (20.0) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (20.0) View
Gingival Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.0) View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.0) View
Gingivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.0) View