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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127097581 | 12709758 | 1 | I | 20130124 | 20160429 | 20160902 | 20160902 | EXP | CA-ORION CORPORATION ORION PHARMA-TREX2016-0313 | ORION | 50.00 | YR | M | Y | 63.00000 | KG | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127097581 | 12709758 | 1 | PS | METHOTREXATE (TRADE NAME UNKNOWN) | METHOTREXATE | 1 | Unknown | N | 0 | TABLET | |||||||||
| 127097581 | 12709758 | 2 | SS | ENBREL | ETANERCEPT | 1 | Unknown | N | 0 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | /wk | ||||||
| 127097581 | 12709758 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | N | 0 | 25 | MG | SOLUTION FOR INJECTION | /wk | ||||||
| 127097581 | 12709758 | 4 | SS | NAPROXEN. | NAPROXEN | 1 | Unknown | U | 0 | 500 | MG | BID | |||||||
| 127097581 | 12709758 | 5 | SS | ORENCIA | ABATACEPT | 1 | Subcutaneous | N | 0 | 125 | MG | /wk | |||||||
| 127097581 | 12709758 | 6 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | N | 0 | ||||||||||
| 127097581 | 12709758 | 7 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | N | 0 | TABLET | |||||||||
| 127097581 | 12709758 | 8 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | N | 0 | SOLUTION FOR INJECTION | |||||||||
| 127097581 | 12709758 | 9 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | ||||||||||
| 127097581 | 12709758 | 10 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | 20 | MG | ||||||||
| 127097581 | 12709758 | 11 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | 2.5 | MG | ||||||||
| 127097581 | 12709758 | 12 | SS | ABATACEPT | ABATACEPT | 1 | Subcutaneous | U | 0 | 125 | MG | ||||||||
| 127097581 | 12709758 | 13 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 4 DAYS A WEEK | 0 | 5 | MG | ||||||||
| 127097581 | 12709758 | 14 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 0 | |||||||||||
| 127097581 | 12709758 | 15 | C | LOVASTATIN. | LOVASTATIN | 1 | Unknown | 0 | |||||||||||
| 127097581 | 12709758 | 16 | C | METOPROLOL. | METOPROLOL | 1 | Unknown | STRENGTH: 50 MG | 0 | ||||||||||
| 127097581 | 12709758 | 17 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 0 | |||||||||||
| 127097581 | 12709758 | 18 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Unknown | 0 | |||||||||||
| 127097581 | 12709758 | 19 | C | TRAMADOL. | TRAMADOL | 1 | Unknown | 0 | |||||||||||
| 127097581 | 12709758 | 20 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Unknown | 0 | |||||||||||
| 127097581 | 12709758 | 21 | C | NAPRELAN | NAPROXEN SODIUM | 1 | Unknown | 0 | |||||||||||
| 127097581 | 12709758 | 22 | C | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 0 | 5 | MG | BID | ||||||||
| 127097581 | 12709758 | 23 | C | NAPROXEN. | NAPROXEN | 1 | Unknown | 0 | |||||||||||
| 127097581 | 12709758 | 24 | C | NAPROXEN SODIUM. | NAPROXEN SODIUM | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127097581 | 12709758 | 2 | Rheumatoid arthritis |
| 127097581 | 12709758 | 3 | Rheumatoid arthritis |
| 127097581 | 12709758 | 4 | Rheumatoid arthritis |
| 127097581 | 12709758 | 5 | Rheumatoid arthritis |
| 127097581 | 12709758 | 6 | Rheumatoid arthritis |
| 127097581 | 12709758 | 7 | Rheumatoid arthritis |
| 127097581 | 12709758 | 8 | Rheumatoid arthritis |
| 127097581 | 12709758 | 9 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127097581 | 12709758 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127097581 | 12709758 | Activities of daily living impaired | |
| 127097581 | 12709758 | Anaemia | |
| 127097581 | 12709758 | Back disorder | |
| 127097581 | 12709758 | Blood albumin decreased | |
| 127097581 | 12709758 | Diverticulum | |
| 127097581 | 12709758 | Drug ineffective | |
| 127097581 | 12709758 | Headache | |
| 127097581 | 12709758 | Intestinal perforation | |
| 127097581 | 12709758 | Lymphadenopathy | |
| 127097581 | 12709758 | Neck mass | |
| 127097581 | 12709758 | Rheumatoid arthritis | |
| 127097581 | 12709758 | Thrombocytosis |
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 |
|---|---|---|---|---|---|---|
| 127097581 | 12709758 | 2 | 20130124 | 2013 | 0 | |
| 127097581 | 12709758 | 5 | 20150620 | 0 | ||
| 127097581 | 12709758 | 22 | 20160704 | 0 |