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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126731931 | 12673193 | 1 | I | 20160811 | 20160822 | 20160822 | EXP | CA-ORION CORPORATION ORION PHARMA-TREX2016-1394 | ORION | 46.00 | YR | F | Y | 0.00000 | 20160822 | CN | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126731931 | 12673193 | 1 | PS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | 0 | 25 | MG | /wk | ||||||||
| 126731931 | 12673193 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | ||||||||||
| 126731931 | 12673193 | 3 | SS | FOLIC ACID. | FOLIC ACID | 1 | Unknown | U | 0 | ||||||||||
| 126731931 | 12673193 | 4 | SS | ARAVA | LEFLUNOMIDE | 1 | Unknown | 0 | 20 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126731931 | 12673193 | 1 | Rheumatoid arthritis |
| 126731931 | 12673193 | 2 | Rheumatoid arthritis |
| 126731931 | 12673193 | 3 | Rheumatoid arthritis |
| 126731931 | 12673193 | 4 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126731931 | 12673193 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126731931 | 12673193 | Drug ineffective | |
| 126731931 | 12673193 | Rheumatoid arthritis |
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 |
|---|---|---|---|---|---|---|
| 126731931 | 12673193 | 1 | 2006 | 0 | ||
| 126731931 | 12673193 | 4 | 20130827 | 20141027 | 0 |