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 |
|---|---|---|---|---|---|---|---|---|
| Phase 1 Part 1: Focus Group Patients and Providers (Months 0-6) | Patients with hematologic cancer and hematology-oncology providers that consented and enrolled to complete a one-time, 60-minute, telehealth focus group. | 0 | None | 0 | 20 | 0 | 20 | View |
| Phase 1 Part 2: Patient User Testing (Months 6-12) and Phase 2: Single-Arm Pilot (Months 12-23) | Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+) The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes. Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills. | 1 | None | 0 | 37 | 0 | 37 | View |