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 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
NCT ID:
NCT02440594
Description:
The research assessment for program evaluation purposes was only done at 3 and 6 months post-randomization; adverse events were not recorded as part of the program evaluation and only death would have been noted at the time of the 3 or 6 month assessments.
Frequency Threshold:
0
Time Frame:
6 months
Study:
NCT02440594
Study Brief:
The PACE/PACENET Behavioral Health Laboratory Project
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Enhanced Monitoring Low-Symptom AD/AX/AP | Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Enhanced BHL Program Services, which for this group include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/ BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Monitoring via a one-time BHP follow-up call with the enrollee after 6 weeks to discuss continuing versus discontinuing the medication. | 2 | None | 0 | 0 | 0 | 0 | View |
| Standard Monitoring Low-Symptom AD/AX/AP | Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues. | 6 | None | 0 | 0 | 0 | 0 | View |
| Enhanced Care High-Symptom AP | Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP. | 3 | None | 0 | 0 | 0 | 0 | View |
| Standard Care High-Symptom AP | Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues. | 1 | None | 0 | 0 | 0 | 0 | View |
| Caregiver TEP Intervention | Caregivers of patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who cannot participate due to cognitive impairment and meet criteria for dementia receive Enhanced BHL Program Services which include: 1) a baseline clinical assessment of caregiver and care recipient factors (e.g., level of disability, burden, safety concerns) and contact information for local community services, and 2) the Telehealth Education Program (TEP) - BHPs provide manual and workbook-guided psychoeducation, support, and skills training. | 0 | None | 0 | 0 | 0 | 0 | View |
| Caregiver Control | Caregivers of patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who cannot participate due to cognitive impairment and meet criteria for dementia receive Standard BHL Program Services, which include a baseline clinical assessment of caregiver and care recipient factors (e.g., level of disability, burden, safety concerns) and contact information for local community services | 1 | None | 0 | 0 | 0 | 0 | View |
| Standard Care High-Symptom AD/AX | Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues. | 10 | None | 0 | 0 | 0 | 0 | View |
| Enhanced Care High-Symptom AD/AX | Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP. | 12 | None | 0 | 0 | 0 | 0 | View |
Serious Events(If Any):
Other Events(If Any):