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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127274391 | 12727439 | 1 | I | 201502 | 20150206 | 20160909 | 20160909 | EXP | CA-AMGEN-CANSP2015013046 | AMGEN | 71.00 | YR | E | F | Y | 0.00000 | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127274391 | 12727439 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | U | 103795 | UNKNOWN FORMULATION | ||||||||
| 127274391 | 12727439 | 2 | SS | METHOTREXATE. | METHOTREXATE | 1 | Oral | 22.5 -25, MG, QWK | 0 | 25 | MG | /wk | |||||||
| 127274391 | 12727439 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 22.5 MG, QWK | 0 | 22.5 | MG | /wk | |||||||
| 127274391 | 12727439 | 4 | SS | SULFATHALIDINE | PHTHALYLSULFATHIAZOLE | 1 | Unknown | UNK | 0 | ||||||||||
| 127274391 | 12727439 | 5 | SS | ARAVA | LEFLUNOMIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 127274391 | 12727439 | 6 | SS | SIMPONI | GOLIMUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 127274391 | 12727439 | 7 | SS | ORENCIA | ABATACEPT | 1 | Unknown | UNK | 0 | ||||||||||
| 127274391 | 12727439 | 8 | SS | ACTEMRA | TOCILIZUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 127274391 | 12727439 | 9 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | 500 MG, BID | 0 | 500 | MG | BID | |||||||
| 127274391 | 12727439 | 10 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | 10 MG, UNK | 0 | 10 | MG | ||||||||
| 127274391 | 12727439 | 11 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | UNK | 0 | ||||||||||
| 127274391 | 12727439 | 12 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 5 MG, QD | 0 | 5 | MG | QD | |||||||
| 127274391 | 12727439 | 13 | C | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 5 MG, BID | 0 | 5 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127274391 | 12727439 | 1 | Rheumatoid arthritis |
| 127274391 | 12727439 | 2 | Rheumatoid arthritis |
| 127274391 | 12727439 | 4 | Product used for unknown indication |
| 127274391 | 12727439 | 5 | Product used for unknown indication |
| 127274391 | 12727439 | 6 | Product used for unknown indication |
| 127274391 | 12727439 | 7 | Product used for unknown indication |
| 127274391 | 12727439 | 8 | Rheumatoid arthritis |
| 127274391 | 12727439 | 9 | Rheumatoid arthritis |
| 127274391 | 12727439 | 10 | Product used for unknown indication |
| 127274391 | 12727439 | 11 | Product used for unknown indication |
| 127274391 | 12727439 | 13 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127274391 | 12727439 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127274391 | 12727439 | Arthralgia | |
| 127274391 | 12727439 | C-reactive protein abnormal | |
| 127274391 | 12727439 | Contusion | |
| 127274391 | 12727439 | Drug ineffective | |
| 127274391 | 12727439 | Drug intolerance | |
| 127274391 | 12727439 | Fatigue | |
| 127274391 | 12727439 | Hepatic enzyme increased | |
| 127274391 | 12727439 | Joint swelling | |
| 127274391 | 12727439 | Laboratory test abnormal | |
| 127274391 | 12727439 | Liver function test increased | |
| 127274391 | 12727439 | Musculoskeletal stiffness | |
| 127274391 | 12727439 | Pain | |
| 127274391 | 12727439 | Rheumatoid arthritis | |
| 127274391 | 12727439 | Treatment failure | |
| 127274391 | 12727439 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 127274391 | 12727439 | 2 | 200806 | 0 | ||
| 127274391 | 12727439 | 3 | 201007 | 201301 | 0 | |
| 127274391 | 12727439 | 8 | 201502 | 0 | ||
| 127274391 | 12727439 | 9 | 200809 | 200812 | 0 | |
| 127274391 | 12727439 | 10 | 200812 | 200902 | 0 | |
| 127274391 | 12727439 | 13 | 20150226 | 0 |