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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 645979712 | 6459797 | 12 | F | 2007 | 20121218 | 20071106 | 20121231 | EXP | US-JNJFOC-20071007549 | JANSSEN | 69.81 | M | Y | 70.00000 | KG | 20121231 | MD | IE | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 645979712 | 6459797 | 1 | PS | REMICADE | 1 | INTRAVENOUS | U | 0 | Lyophilized Powder | ||||||||||
| 645979712 | 6459797 | 2 | SS | REMICADE | 1 | INTRAVENOUS | U | 0 | Lyophilized Powder | ||||||||||
| 645979712 | 6459797 | 3 | SS | CYTOXAN | 1 | ORAL | D | 0 | 50 | MG | TID | ||||||||
| 645979712 | 6459797 | 4 | SS | CYTOXAN | 1 | ORAL | D | 0 | |||||||||||
| 645979712 | 6459797 | 5 | SS | PLAQUENIL | 1 | D | 0 | ||||||||||||
| 645979712 | 6459797 | 6 | SS | PLAQUENIL | 1 | D | 0 | 200 | MG | BID | |||||||||
| 645979712 | 6459797 | 7 | SS | PREDNISONE | 1 | D | 0 | 5 | MG | ||||||||||
| 645979712 | 6459797 | 8 | SS | PREDNISONE | 1 | D | 0 | ||||||||||||
| 645979712 | 6459797 | 9 | SS | COLCHICINE | 1 | D | 0 | .6 | MG | ||||||||||
| 645979712 | 6459797 | 10 | C | FLECAINIDE | 1 | D | 0 | 200 | MG | BID | |||||||||
| 645979712 | 6459797 | 11 | C | HYTRIN | 1 | D | 0 | ||||||||||||
| 645979712 | 6459797 | 12 | C | ATENOLOL | 1 | D | 0 | ||||||||||||
| 645979712 | 6459797 | 13 | C | POTASSIUM | 1 | D | 0 | ||||||||||||
| 645979712 | 6459797 | 14 | C | LASIX | 1 | D | 0 | 20 | MG | ||||||||||
| 645979712 | 6459797 | 15 | C | ASPIRIN | 1 | D | 0 | 81 | MG | BID | |||||||||
| 645979712 | 6459797 | 16 | C | THEO-DUR | 1 | D | 0 | 100 | MG | BID | |||||||||
| 645979712 | 6459797 | 17 | C | RESTORIL | 1 | D | 0 | 15 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 645979712 | 6459797 | 1 | Rheumatoid arthritis |
| 645979712 | 6459797 | 2 | Vasculitis |
| 645979712 | 6459797 | 3 | Rheumatoid vasculitis |
| 645979712 | 6459797 | 4 | Rheumatoid vasculitis |
| 645979712 | 6459797 | 5 | Product used for unknown indication |
| 645979712 | 6459797 | 6 | Product used for unknown indication |
| 645979712 | 6459797 | 7 | Vasculitis |
| 645979712 | 6459797 | 8 | Vasculitis |
| 645979712 | 6459797 | 9 | Product used for unknown indication |
| 645979712 | 6459797 | 15 | Prophylaxis |
| 645979712 | 6459797 | 16 | Chronic obstructive pulmonary disease |
| 645979712 | 6459797 | 17 | Sleep disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 645979712 | 6459797 | DE |
| 645979712 | 6459797 | HO |
| 645979712 | 6459797 | LT |
| 645979712 | 6459797 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 645979712 | 6459797 | Aphasia | |
| 645979712 | 6459797 | Asthenia | |
| 645979712 | 6459797 | Cerebrovascular accident | |
| 645979712 | 6459797 | Confusional state | |
| 645979712 | 6459797 | Decreased appetite | |
| 645979712 | 6459797 | Dysarthria | |
| 645979712 | 6459797 | Hemiparesis | |
| 645979712 | 6459797 | Multi-organ failure | |
| 645979712 | 6459797 | Nervous system disorder | |
| 645979712 | 6459797 | Progressive multifocal leukoencephalopathy | |
| 645979712 | 6459797 | Respiratory failure | |
| 645979712 | 6459797 | Urinary incontinence |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 645979712 | 6459797 | 1 | 200708 | 0 | ||
| 645979712 | 6459797 | 2 | 200708 | 0 | ||
| 645979712 | 6459797 | 4 | 200708 | 0 |