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:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
NCT ID:
NCT01928758
Description:
Adverse events (AEs) were systematically collected at each study visit by asking participants about any changes in their physical or mental health or if they needed to seek immediate medical care at an emergency room or hospital.
Frequency Threshold:
5
Time Frame:
All randomized participants throughout the entire 33 weeks of the trial.
Study:
NCT01928758
Study Brief:
Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Reduced Nicotine Content Cigarettes | The experimental group will smoke cigarettes with gradually Reduced Nicotine Content (11.6, 8.6, 4.0, 1.8, 0.9 and 0.3 mg per cigarette) cigarettes, with each nicotine level smoked for 3 weeks, except the lowest level which continues for 6 weeks Reduced Nicotine Content Cigarettes: Research cigarettes will have gradually reduced nicotine content | 0 | None | 7 | 94 | 70 | 94 | View |
| Usual Nicotine Content Cigarettes | Research cigarettes with a nicotine content similar to participant's usual brand of cigarettes (around 11.6mg) Usual Nicotine Content Cigarettes: Usual Nicotine Content Cigarettes | 0 | None | 10 | 94 | 72 | 94 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Musculoskeletal and connective tissue disorder - Other | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Psychiatric disorders - Other | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| Respiratory, thoracic and mediastinal disorders - Other | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| Surgical and medical procedures - Other | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (12.0) | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Aortic valve disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Injury, poisoning and procedural complications - Other | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Cardiac disorders - Other | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Endocarditis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| Heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Infections and infestations - Other | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Allergic rhinitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| Flu like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Respiratory, thoracic and mediastinal disorders - Other | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| Surgical and medical procedures - Other | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (12.0) | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |