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 @ 4:01 PM
Ignite Modification Date:
2025-12-25 @ 2:04 PM
NCT ID:
NCT05030766
Description:
None
Frequency Threshold:
0
Time Frame:
3 months
Study:
NCT05030766
Study Brief:
Testing Integrative Smoking Cessation for HIV Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Contingency Management (CM) and NRT (Phase 1) | Participants who receive the Contingency Management (CM) intervention for 4 weeks in addition to 6 weeks of NRT. These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention. Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches Contingency Management Smoking Cessation Intervention: Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom. | 0 | None | 0 | 46 | 0 | 46 | View |
| Contingency Management (CM) and NRT + Additional MT Group (Phase 2) | Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks. Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches Mindfulness Training Smoking Cessation Intervention: Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions. Contingency Management Smoking Cessation Intervention: Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom. | 0 | None | 0 | 10 | 0 | 10 | View |
| Mindfulness Training (MT) and NRT (Phase 1) | Participants who receive the Mindfulness Training (MT) intervention for 4 weeks in addition to 6 weeks of Nicotine Replacement Therapy (NRT).These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention. Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches Mindfulness Training Smoking Cessation Intervention: Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions. | 0 | None | 0 | 49 | 0 | 49 | View |
| Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2) | Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks. Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches Mindfulness Training Smoking Cessation Intervention: Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions. Contingency Management Smoking Cessation Intervention: Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom. | 0 | None | 0 | 12 | 0 | 12 | View |
Serious Events(If Any):
Other Events(If Any):