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 @ 2:12 PM
Ignite Modification Date:
2025-12-25 @ 12:51 PM
NCT ID:
NCT01829295
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse event data were collected through the primary endpoint (the first 6 months) for each enrolled patient; Phase I, 0-6 Months.
Study:
NCT01829295
Study Brief:
Methotrexate and Mycophenolate Mofetil for UVEITIS
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Methotrexate | oral methotrexate Patients randomized to receive oral methotrexate in Phase I, 0-6 Months. Methotrexate: For the first two weeks, an introductory dose of 15 mg/week (7.5mg BID once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week) Prednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study. | 1 | None | 7 | 107 | 99 | 107 | View |
| Mycophenolate Mofetil | oral mycophenolate mofetil Patients randomized to receive oral mycophenolate mofetil in Phase I, 0-6 Months. Mycophenolate mofetil: For the first two weeks, an introductory dose of 500 mg BID orally. After two weeks, the dose will be increased to 1.5 g BID. Prednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study. | 0 | None | 7 | 109 | 100 | 109 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| SGOT and SGPT | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Disability or permanent damage | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hospitalization | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Serious systemic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Other serious/systemic event | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Suspected/confirmed glaucoma diagnosis | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Hypotony | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Ocular hypertension | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Peripheral and/or central vitreous hemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Other ocular event | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Leukocytes | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| SGOT or SGPT | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Allergic reaction | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mild congestive heart failure or arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hair loss | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Non-serious systemic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Mood changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Numbness/tingling | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Other systemic (no treatment required) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Decrease in vision/defective vision | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |