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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111961243 | 11196124 | 3 | F | 20150605 | 20160831 | 20150617 | 20160909 | EXP | CA-AMGEN-CANSP2015058226 | AMGEN | 69.00 | YR | E | F | Y | 0.00000 | 20160909 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111961243 | 11196124 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | UNK | U | 103795 | UNKNOWN FORMULATION | ||||||||
| 111961243 | 11196124 | 2 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Oral | 1 G, BID | 0 | 1 | G | BID | |||||||
| 111961243 | 11196124 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 20 MG, QWK | 0 | 20 | MG | /wk | |||||||
| 111961243 | 11196124 | 4 | SS | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 5 MG, BID | 0 | 5 | MG | BID | |||||||
| 111961243 | 11196124 | 5 | SS | CELEBREX | CELECOXIB | 1 | Oral | UNK | 0 | CAPSULE | |||||||||
| 111961243 | 11196124 | 6 | C | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 111961243 | 11196124 | 7 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | UNK | 0 | ||||||||||
| 111961243 | 11196124 | 8 | C | MORPHINE | MORPHINE | 1 | UNK | 0 | |||||||||||
| 111961243 | 11196124 | 9 | C | HYDROXYCHLOROQUINE | HYDROXYCHLOROQUINE | 1 | Unknown | 400 MG, QD | 0 | 400 | MG | QD | |||||||
| 111961243 | 11196124 | 10 | C | SIMPONI | GOLIMUMAB | 1 | UNK | 0 | |||||||||||
| 111961243 | 11196124 | 11 | C | ARAVA | LEFLUNOMIDE | 1 | UNK | 0 | |||||||||||
| 111961243 | 11196124 | 12 | C | PREDNISONE. | PREDNISONE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111961243 | 11196124 | 1 | Rheumatoid arthritis |
| 111961243 | 11196124 | 2 | Rheumatoid arthritis |
| 111961243 | 11196124 | 3 | Rheumatoid arthritis |
| 111961243 | 11196124 | 4 | Rheumatoid arthritis |
| 111961243 | 11196124 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111961243 | 11196124 | OT |
| 111961243 | 11196124 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111961243 | 11196124 | Cystitis | |
| 111961243 | 11196124 | Drug effect decreased | |
| 111961243 | 11196124 | Drug ineffective | |
| 111961243 | 11196124 | Joint swelling | |
| 111961243 | 11196124 | Pneumonitis | |
| 111961243 | 11196124 | 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 |
|---|---|---|---|---|---|---|
| 111961243 | 11196124 | 2 | 200802 | 0 | ||
| 111961243 | 11196124 | 3 | 200802 | 200910 | 0 | |
| 111961243 | 11196124 | 4 | 20150625 | 0 | ||
| 111961243 | 11196124 | 6 | 200907 | 200910 | 0 |