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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1118294315 | 11182943 | 15 | F | 20160708 | 20150611 | 20160713 | EXP | CA-PFIZER INC-2015191806 | PFIZER | 72.00 | YR | F | Y | 0.00000 | 20160713 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1118294315 | 11182943 | 1 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, WEEKLY | N | 0 | 50 | MG | /wk | ||||||
| 1118294315 | 11182943 | 2 | PS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Subcutaneous | 20 MG, UNK | N | 11719 | 20 | MG | SOLUTION FOR INJECTION | ||||||
| 1118294315 | 11182943 | 3 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Subcutaneous | 25 MG, UNK | N | 11719 | 25 | MG | SOLUTION FOR INJECTION | ||||||
| 1118294315 | 11182943 | 4 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Subcutaneous | 10 MG, UNK | N | 11719 | 10 | MG | SOLUTION FOR INJECTION | ||||||
| 1118294315 | 11182943 | 5 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Subcutaneous | 7.5 MG, UNK | N | 11719 | 7.5 | MG | SOLUTION FOR INJECTION | ||||||
| 1118294315 | 11182943 | 6 | SS | CELEBREX | CELECOXIB | 1 | UNK | 20998 | CAPSULE, HARD | ||||||||||
| 1118294315 | 11182943 | 7 | SS | CELEBREX | CELECOXIB | 1 | 20998 | CAPSULE, HARD | |||||||||||
| 1118294315 | 11182943 | 8 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | 2 G, UNK | N | 7073 | 2 | G | ||||||||
| 1118294315 | 11182943 | 9 | SS | ARAVA | LEFLUNOMIDE | 1 | UNK | 0 | |||||||||||
| 1118294315 | 11182943 | 10 | SS | ARAVA | LEFLUNOMIDE | 1 | 0 | ||||||||||||
| 1118294315 | 11182943 | 11 | SS | PREDNISONE. | PREDNISONE | 1 | UNK | N | 0 | ||||||||||
| 1118294315 | 11182943 | 12 | SS | ORENCIA | ABATACEPT | 1 | 250 UNK, UNK | U | 0 | ||||||||||
| 1118294315 | 11182943 | 13 | SS | RITUXAN | RITUXIMAB | 1 | UNK | N | 0 | ||||||||||
| 1118294315 | 11182943 | 14 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | 300 MG, UNK | N | 0 | 300 | MG | ||||||||
| 1118294315 | 11182943 | 15 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Oral | 20 MG, UNK | N | 0 | 20 | MG | TABLET | ||||||
| 1118294315 | 11182943 | 16 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | 20 MG, UNK | N | 0 | 20 | MG | TABLET | |||||||
| 1118294315 | 11182943 | 17 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | 10 MG, UNK | N | 0 | 10 | MG | TABLET | |||||||
| 1118294315 | 11182943 | 18 | 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 |
|---|---|---|---|
| 1118294315 | 11182943 | 1 | Rheumatoid arthritis |
| 1118294315 | 11182943 | 2 | Rheumatoid arthritis |
| 1118294315 | 11182943 | 6 | Arthritis |
| 1118294315 | 11182943 | 7 | Rheumatoid arthritis |
| 1118294315 | 11182943 | 8 | Rheumatoid arthritis |
| 1118294315 | 11182943 | 9 | Arthritis |
| 1118294315 | 11182943 | 10 | Rheumatoid arthritis |
| 1118294315 | 11182943 | 11 | Arthritis |
| 1118294315 | 11182943 | 12 | Rheumatoid arthritis |
| 1118294315 | 11182943 | 13 | Rheumatoid arthritis |
| 1118294315 | 11182943 | 14 | Rheumatoid arthritis |
| 1118294315 | 11182943 | 15 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1118294315 | 11182943 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1118294315 | 11182943 | Condition aggravated | |
| 1118294315 | 11182943 | Drug ineffective | |
| 1118294315 | 11182943 | Hepatotoxicity | |
| 1118294315 | 11182943 | Nausea | |
| 1118294315 | 11182943 | Neoplasm malignant | |
| 1118294315 | 11182943 | Oral candidiasis | |
| 1118294315 | 11182943 | Rheumatoid arthritis | |
| 1118294315 | 11182943 | Thyroid neoplasm |
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 |
|---|---|---|---|---|---|---|
| 1118294315 | 11182943 | 1 | 200612 | 201302 | 0 | |
| 1118294315 | 11182943 | 2 | 200105 | 200302 | 0 | |
| 1118294315 | 11182943 | 3 | 200302 | 200310 | 0 | |
| 1118294315 | 11182943 | 4 | 200311 | 200312 | 0 | |
| 1118294315 | 11182943 | 5 | 200612 | 201302 | 0 | |
| 1118294315 | 11182943 | 8 | 200105 | 200302 | 0 | |
| 1118294315 | 11182943 | 11 | 201412 | 0 | ||
| 1118294315 | 11182943 | 12 | 201302 | 0 | ||
| 1118294315 | 11182943 | 14 | 200105 | 200302 | 0 | |
| 1118294315 | 11182943 | 15 | 200302 | 200310 | 0 | |
| 1118294315 | 11182943 | 16 | 200311 | 200312 | 0 | |
| 1118294315 | 11182943 | 17 | 201302 | 0 |