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 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
NCT ID:
NCT02407704
Description:
None
Frequency Threshold:
5
Time Frame:
12 weeks
Study:
NCT02407704
Study Brief:
A Multi-level Life-span Characterization of Adult-depression and Effects of Medication and Exercise
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Aerobic Exercise + Venlafaxine XR (60-79 Years of Age) | Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks. Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention. Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours). | 0 | None | 0 | 2 | 1 | 2 | View |
| Venlafaxine XR Only (60-79 Years of Age) | Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks. Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours). Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form. | 0 | None | 0 | 3 | 3 | 3 | View |
| Aerobic Exercise + Venlafaxine XR (20-39 Years of Age) | Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks. Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention. Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours). | 0 | None | 0 | 4 | 4 | 4 | View |
| Venlafaxine XR Only (20-39 Years of Age) | Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks. Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours). Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form. | 0 | None | 0 | 4 | 4 | 4 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dry mouth | SYSTEMATIC_ASSESSMENT | General disorders | ASEC | View |
| Drowsiness | SYSTEMATIC_ASSESSMENT | General disorders | ASEC | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | ASEC | View |
| Blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | ASEC | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | ASEC | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | ASEC | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | ASEC | View |
| Increased appetite | SYSTEMATIC_ASSESSMENT | General disorders | ASEC | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | General disorders | ASEC | View |
| Nausea/Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | ASEC | View |
| Problems with urination | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | ASEC | View |
| Problems with Sexual Function | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | ASEC | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | ASEC | View |
| Feeling light-headed on standing | SYSTEMATIC_ASSESSMENT | General disorders | ASEC | View |
| Feeling like the room is spinning | SYSTEMATIC_ASSESSMENT | General disorders | ASEC | View |
| Sweating | SYSTEMATIC_ASSESSMENT | General disorders | ASEC | View |
| Increased Body Temperature | SYSTEMATIC_ASSESSMENT | General disorders | ASEC | View |
| Tremor | SYSTEMATIC_ASSESSMENT | General disorders | ASEC | View |
| Disorientation | SYSTEMATIC_ASSESSMENT | General disorders | ASEC | View |
| Yawning | SYSTEMATIC_ASSESSMENT | General disorders | ASEC | View |
| Weight Gain | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | ASEC | View |
| Stiff Neck | SYSTEMATIC_ASSESSMENT | General disorders | ASEC | View |
| Bloatedness | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | ASEC | View |
| Agitation | SYSTEMATIC_ASSESSMENT | General disorders | ASEC | View |
| Jaw pain | SYSTEMATIC_ASSESSMENT | General disorders | ASEC | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | ASEC | View |