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 |
|---|---|---|---|---|---|---|---|---|
| CRP<1, CRP Consistent Antidepressant Selection | Participants with CRP\<1 will be prescribed escitalopram Escitalopram: Escitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study. | 0 | None | 0 | 4 | 3 | 4 | View |
| CRP> or Equal to 1, CRP Consistent Antidepressant Selection | Participants with CRP\> or equal to 1 will be prescribed bupropion XL Bupropion: Bupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study. | 0 | None | 0 | 2 | 1 | 2 | View |
| CRP<1, CRP Inconsistent Antidepressant Selection | Participants with CRP\< 1 will be prescribed bupropion XL Bupropion: Bupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study. | 0 | None | 0 | 1 | 1 | 1 | View |
| CRP> or Equal to 1, CRP Inconsistent Antidepressant Selection | Participants with CRP\> or equal to 1 will be prescribed escitalopram Escitalopram: Escitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study. | 0 | None | 0 | 4 | 1 | 4 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| lower back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| worsening anxiety symptoms | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| night insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| headaches | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| mouth sores | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| epigastric pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| heart palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| heartburn | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| upset stomach | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |