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:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
NCT ID:
NCT02789020
Description:
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
Frequency Threshold:
0
Time Frame:
1 year (the follow-up occurred one year after the baseline visit)
Study:
NCT02789020
Study Brief:
Image Parkinson's Disease Progression Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Rasagiline | This group will receive a 1 mg rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale. Rasagiline: Rasagiline will be taken for one year at the dose of 1mg a day. and subjects will undergo functional and structural brain imaging to determine if rasagiline is slowing the progression of Parkinson's Disease in the brain. Magnetic Resonance Imaging: This test will be performed at baseline and one year. functional Magnetic Resonance Imaging: This test will be performed at baseline and one year. Physical Function Performance Test: This test will be performed at baseline and one year. | 0 | None | 0 | 45 | 12 | 45 | View |
| Placebo | This group will receive a placebo tablet in the same forum as the rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale. Placebo: A placebo tablet will be taken for one year, once a day, and at the same dose of 1mg. subjects will undergo functional and structural brain imaging to be compared with the group taking the rasagiline intervention. Magnetic Resonance Imaging: This test will be performed at baseline and one year. functional Magnetic Resonance Imaging: This test will be performed at baseline and one year. Physical Function Performance Test: This test will be performed at baseline and one year. | 0 | None | 0 | 45 | 9 | 45 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Orthostatic Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Weight Loss | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypersexuality | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | None | View |
| Headaches | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Falls | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hair Loss | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Joint Pain/Stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Vertigo/Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Edema | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | None | View |
| Light-Headedness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Increased Resting Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dizziness and Light-Headedness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |