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 @ 9:17 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
NCT ID:
NCT01902004
Description:
None
Frequency Threshold:
0
Time Frame:
1 year
Study:
NCT01902004
Study Brief:
Brain Aging and Treatment Response in Geriatric Depression
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Escitalopram and Memantine | Participants will take a combination of Escitalopram and Memantine for 12 months Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion. Memantine: Memantine dosage will be 5 to 20mg a day. Participants will initially take one 5mg capsule once a day, which will be gradually increased to a maximum of 10mg capsules twice per day. | 0 | None | 0 | 48 | 41 | 48 | View |
| Escitalopram and Placebo | Participants will take a combination of Escitalopram and placebo for 12 months Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion. Placebo: Placebo pills will be taken in combination with the active Namenda (Memantine) pills. Participants will initially take 1 capsule per day, which will be increased to a maximum of 1 capsule twice per day. | 0 | None | 0 | 47 | 41 | 47 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Concentration Difficulties | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Asthenia/Lassitude/Increased Fatigability | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Sleepiness/Sedation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Failing Memory | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Tension/Inner Unrest | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Increased Duration of Sleep | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Reduced Duration of Sleep | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Increased Dream Activity | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Accomodation Disturbance | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Increased Salivation | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Reduced Salivation | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nausea/Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Micturtion Disturbances | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Polyuria/Polydipsia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Orthostatic Dizziness | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Palpitations/Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Increased Tendancy to Sweating | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Weight Gain | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Diminished Sexual Drive | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Erectile Dysfunction | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Ejaculatory Dysfunction | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Orgastic Dysfunction | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |