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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127656081 | 12765608 | 1 | I | 20160211 | 20160921 | 20160921 | EXP | CA-BRISTOL-MYERS SQUIBB COMPANY-BMS-2016-011586 | BRISTOL MYERS SQUIBB | 54.00 | YR | F | Y | 0.00000 | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127656081 | 12765608 | 1 | PS | ORENCIA | ABATACEPT | 1 | Unknown | 1000 MG, Q4WK | U | 125118 | 1000 | MG | |||||||
| 127656081 | 12765608 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | 40 MG, Q2WK | N | 0 | 40 | MG | QOW | ||||||
| 127656081 | 12765608 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | UNK UNK, Q2WK | N | 0 | |||||||||
| 127656081 | 12765608 | 4 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | 40.0 MG, QCYCLE | N | 0 | 40 | MG | |||||||
| 127656081 | 12765608 | 5 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Oral | 25.0 MG, UNK | U | 0 | 25 | MG | |||||||
| 127656081 | 12765608 | 6 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | 20.0 MG, QD | U | 0 | 20 | MG | TABLET | QD | |||||
| 127656081 | 12765608 | 7 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 25.0 MG, QWK | U | 0 | 25 | MG | /wk | ||||||
| 127656081 | 12765608 | 8 | C | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | UNK | U | 0 | |||||||||
| 127656081 | 12765608 | 9 | C | PLAQUENIL /00072602/ | HYDROXYCHLOROQUINE DIPHOSPHATE | 1 | Unknown | 400 MG, QD | U | 0 | 400 | MG | TABLET | QD | |||||
| 127656081 | 12765608 | 10 | C | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 1000 MG, UNK | U | 0 | 1000 | MG | |||||||
| 127656081 | 12765608 | 11 | C | HYDROXYCHLOROQUINE | HYDROXYCHLOROQUINE | 1 | Unknown | U | 0 | ||||||||||
| 127656081 | 12765608 | 12 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127656081 | 12765608 | 1 | Rheumatoid arthritis |
| 127656081 | 12765608 | 2 | Rheumatoid arthritis |
| 127656081 | 12765608 | 5 | Product used for unknown indication |
| 127656081 | 12765608 | 6 | Rheumatoid arthritis |
| 127656081 | 12765608 | 7 | Rheumatoid arthritis |
| 127656081 | 12765608 | 8 | Product used for unknown indication |
| 127656081 | 12765608 | 9 | Rheumatoid arthritis |
| 127656081 | 12765608 | 10 | Rheumatoid arthritis |
| 127656081 | 12765608 | 11 | Product used for unknown indication |
| 127656081 | 12765608 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127656081 | 12765608 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127656081 | 12765608 | Drug ineffective | |
| 127656081 | 12765608 | Foot deformity | |
| 127656081 | 12765608 | Gait disturbance | |
| 127656081 | 12765608 | Treatment failure |
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 |
|---|---|---|---|---|---|---|
| 127656081 | 12765608 | 1 | 200811 | 200908 | 0 | |
| 127656081 | 12765608 | 2 | 200510 | 2007 | 0 | |
| 127656081 | 12765608 | 3 | 200909 | 20160126 | 0 | |
| 127656081 | 12765608 | 8 | 200410 | 0 | ||
| 127656081 | 12765608 | 9 | 2004 | 0 | ||
| 127656081 | 12765608 | 10 | 2008 | 0 |