Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126336501 | 12633650 | 1 | I | 20160802 | 20160809 | 20160809 | EXP | IL-STRIDES ARCOLAB LIMITED-2016SP011224 | STRIDES | FELD J, SHUPAK A, ZISMAN D. DIFFUSE SYSTEMIC SCLEROSIS PRESENTING AS MENIERE^S DISEASE-LIKE SYMPTOMS AS PART OF AUTOIMMUNE INNER EAR DISEASE. ISR MED ASSOC J. 2015;17(4):263-264 | 0.00 | Y | 0.00000 | 20160809 | MD | IL | IL |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126336501 | 12633650 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | UNK | U | U | 90055 | |||||||||
| 126336501 | 12633650 | 2 | SS | CORTICOSTEROIDS | CORTICOSTEROID NOS | 1 | HIGH DOSE | 0 | |||||||||||
| 126336501 | 12633650 | 3 | SS | IMMUNOGLOBULINS | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 126336501 | 12633650 | 4 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | UNK | 0 | |||||||||||
| 126336501 | 12633650 | 5 | SS | BOSENTAN. | BOSENTAN | 1 | UNK | 0 | |||||||||||
| 126336501 | 12633650 | 6 | C | METHOTREXATE. | METHOTREXATE | 1 | 20 MG, ONCE A WEEK | 0 | 20 | MG | |||||||||
| 126336501 | 12633650 | 7 | C | PREDNISONE. | PREDNISONE | 1 | 1 MG/KG, UNK | 0 | 1 | MG/KG | |||||||||
| 126336501 | 12633650 | 8 | C | PREDNISONE. | PREDNISONE | 1 | 5 MG, PER DAY | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126336501 | 12633650 | 1 | Systemic scleroderma |
| 126336501 | 12633650 | 2 | Systemic scleroderma |
| 126336501 | 12633650 | 3 | Systemic scleroderma |
| 126336501 | 12633650 | 4 | Systemic scleroderma |
| 126336501 | 12633650 | 5 | Systemic scleroderma |
| 126336501 | 12633650 | 6 | Autoimmune inner ear disease |
| 126336501 | 12633650 | 7 | Autoimmune inner ear disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126336501 | 12633650 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126336501 | 12633650 | Drug ineffective for unapproved indication | |
| 126336501 | 12633650 | Off label use |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |