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 |
|---|---|---|---|---|---|---|---|---|
| Cognitive Behavioral Therapy | 8 weekly telephone-based sessions and 2 booster sessions Telephone-based Cognitive Behavioral Therapy: Cognitive behavioral therapy (CBT) is a behavioral-based treatment that promotes effective self-management skills, including adaptive thought processes and behaviors (i.e. "coping skills"). CBT also commonly teaches goal-setting and behavioral activation strategies for engaging in physical, social, and other valued activities in the context of fatigue. | 0 | None | 1 | 114 | 1 | 114 | View |
| Modafinil | 50-400 mg per day (oral) Modafinil: Modafinil is a safe, well-tolerated and effective wake-promoting agent (oral medication) that is FDA-approved for the treatment of fatigue related to sleep disorders. Modafinil is also one of the most commonly used medications for multiple sclerosis related fatigue in clinical practice, with doses ranging from 50 - 400 mg per day, in divided doses (once to twice daily). | 1 | None | 4 | 114 | 12 | 114 | View |
| Cognitive Behavioral Therapy + Modafinil | Telephone-based cognitive behavioral therapy (8 weekly therapy sessions and 2 booster sessions) + Modafinil 50-400 mg per day (oral) Telephone-based Cognitive Behavioral Therapy: Cognitive behavioral therapy (CBT) is a behavioral-based treatment that promotes effective self-management skills, including adaptive thought processes and behaviors (i.e. "coping skills"). CBT also commonly teaches goal-setting and behavioral activation strategies for engaging in physical, social, and other valued activities in the context of fatigue. Modafinil: Modafinil is a safe, well-tolerated and effective wake-promoting agent (oral medication) that is FDA-approved for the treatment of fatigue related to sleep disorders. Modafinil is also one of the most commonly used medications for multiple sclerosis related fatigue in clinical practice, with doses ranging from 50 - 400 mg per day, in divided doses (once to twice daily). | 0 | None | 1 | 108 | 19 | 108 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Localized edema | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Trigeminal neuralgia pain | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Surgical/Medical procedure | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Benign paroxysmal vertigo | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Cerebrospinal fluid leakage | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| MS relapse/exacerbation | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |