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 @ 9:28 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
NCT ID:
NCT01480232
Description:
None
Frequency Threshold:
5
Time Frame:
week 1 to week 12
Study:
NCT01480232
Study Brief:
A Safety and Cognitive Function Study of EVP-6124 Versus Placebo in Subjects With Nicotine Dependence
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| EVP-6124 + NicoDerm (Active) | One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days) EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. | None | None | 1 | 40 | 35 | 40 | View |
| EVP-6124 + NRT Patch (Placebo) | One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days) EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. | None | None | 1 | 41 | 30 | 41 | View |
| Placebo + NicoDerm (Active) | One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days) Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days) NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. | None | None | 1 | 38 | 34 | 38 | View |
| Placebo + NRT Patch (Placebo) | One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days) Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days) NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. | None | None | 0 | 41 | 34 | 41 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Elevated Creatine phosphokinase (CPK) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Depressive symptoms | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cold/flu | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Skin Irritation at Patch Site | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Stomach pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| weight gain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Increase appetite | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Muscle spasm | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Allergies | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Abnormal sleeping pattern | SYSTEMATIC_ASSESSMENT | General disorders | None | View |