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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122126783 | 12212678 | 3 | F | 20150729 | 20160920 | 20160328 | 20160926 | EXP | CA-AMGEN-CANSP2016036511 | AMGEN | 76.00 | YR | E | M | Y | 0.00000 | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122126783 | 12212678 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | U | 103795 | UNKNOWN FORMULATION | ||||||||
| 122126783 | 12212678 | 2 | SS | ARAVA | LEFLUNOMIDE | 1 | Unknown | 20 MG/D, M-W-F | 0 | 20 | MG | ||||||||
| 122126783 | 12212678 | 3 | SS | ARAVA | LEFLUNOMIDE | 1 | Unknown | 10 MG/D, 4X/WEEK | 0 | 10 | MG | ||||||||
| 122126783 | 12212678 | 4 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | 500 MG, BID | 0 | 500 | MG | BID | |||||||
| 122126783 | 12212678 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | 25 MG, QWK | 0 | 25 | MG | /wk | |||||||
| 122126783 | 12212678 | 6 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | 1000 MG, BID | 0 | 1000 | MG | BID | |||||||
| 122126783 | 12212678 | 7 | C | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 5 MG, BID (2X/DAY) | 0 | 5 | MG | BID | |||||||
| 122126783 | 12212678 | 8 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | 1200 MCG, 1 TABLET 1 TIME PER DAY | 0 | TABLET | QD | |||||||||
| 122126783 | 12212678 | 9 | C | ENDOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | 5+325 MG, 1 TABLET 2 TIMES PER DAY PRN | 0 | TABLET | ||||||||||
| 122126783 | 12212678 | 10 | C | INDOMETHACIN. | INDOMETHACIN | 1 | UNK | 0 | |||||||||||
| 122126783 | 12212678 | 11 | C | PENNSAID | DICLOFENAC SODIUM | 1 | UNK | 0 | |||||||||||
| 122126783 | 12212678 | 12 | C | OXYCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | 2 TABS, 4-5X/WEEK | 0 | TABLET | ||||||||||
| 122126783 | 12212678 | 13 | C | ASA | ASPIRIN | 1 | 325 MG OCC, UNK | 0 | 325 | MG | |||||||||
| 122126783 | 12212678 | 14 | C | NAPRELAN | NAPROXEN SODIUM | 1 | 1000 MG, 1-2X/MONTH | 0 | 1000 | MG | |||||||||
| 122126783 | 12212678 | 15 | C | METOPROLOL. | METOPROLOL | 1 | 75 MG, BID | 0 | 75 | MG | BID | ||||||||
| 122126783 | 12212678 | 16 | C | FOLIC ACID. | FOLIC ACID | 1 | 5 MG, 3 TIMES/WK | 0 | 5 | MG | TIW | ||||||||
| 122126783 | 12212678 | 17 | C | BISOPROLOL | BISOPROLOL | 1 | 5 MG, QD | 0 | 5 | MG | QD | ||||||||
| 122126783 | 12212678 | 18 | C | LAX-A-DAY | 2 | UNK, OCC | 0 | ||||||||||||
| 122126783 | 12212678 | 19 | C | PREDNISONE. | PREDNISONE | 1 | 1 MG, QD | 0 | 1 | MG | QD | ||||||||
| 122126783 | 12212678 | 20 | C | OMEGA 3 | OMEGA-3 FATTY ACIDS | 1 | 12000 MG, QD | 0 | 12000 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122126783 | 12212678 | 1 | Rheumatoid arthritis |
| 122126783 | 12212678 | 2 | Product used for unknown indication |
| 122126783 | 12212678 | 4 | Rheumatoid arthritis |
| 122126783 | 12212678 | 5 | Rheumatoid arthritis |
| 122126783 | 12212678 | 6 | Product used for unknown indication |
| 122126783 | 12212678 | 7 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122126783 | 12212678 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122126783 | 12212678 | Abdominal discomfort | |
| 122126783 | 12212678 | Arthralgia | |
| 122126783 | 12212678 | Arthritis | |
| 122126783 | 12212678 | Cardiac failure congestive | |
| 122126783 | 12212678 | Drug effect decreased | |
| 122126783 | 12212678 | Dyspnoea | |
| 122126783 | 12212678 | Joint swelling | |
| 122126783 | 12212678 | Lung disorder | |
| 122126783 | 12212678 | Musculoskeletal pain | |
| 122126783 | 12212678 | Peripheral swelling | |
| 122126783 | 12212678 | Pulmonary toxicity | |
| 122126783 | 12212678 | Vascular graft |
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 |
|---|---|---|---|---|---|---|
| 122126783 | 12212678 | 6 | 201111 | 201204 | 0 | |
| 122126783 | 12212678 | 7 | 20160325 | 0 | ||
| 122126783 | 12212678 | 8 | 20160321 | 0 | ||
| 122126783 | 12212678 | 9 | 20160321 | 0 |