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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Participate in vaping session with tobacco flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. | 0 | None | 0 | 64 | 0 | 64 | View |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Participate in vaping session with menthol flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. | 0 | None | 0 | 64 | 0 | 64 | View |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Participate in vaping session with tobacco flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. | 0 | None | 0 | 63 | 0 | 63 | View |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Participate in vaping session with menthol flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. | 0 | None | 0 | 60 | 0 | 60 | View |
| Usual Brand | Participate in vaping session with their usual brand e-cigarette including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. | 0 | None | 0 | 87 | 0 | 87 | View |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Participate in vaping session with menthol flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. | 0 | None | 0 | 65 | 0 | 65 | View |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Participate in vaping session with tobacco flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. | 0 | None | 0 | 64 | 0 | 64 | View |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Participate in vaping session with menthol flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. | 0 | None | 0 | 61 | 0 | 61 | View |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Participate in vaping session with tobacco flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. | 0 | None | 0 | 65 | 0 | 65 | View |