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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119650315 | 11965031 | 5 | F | 20160725 | 20160127 | 20160801 | EXP | CA-AMGEN-CANSP2015136932 | AMGEN | 60.00 | YR | A | F | Y | 0.00000 | 20160731 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119650315 | 11965031 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | UNK | U | 103795 | UNKNOWN FORMULATION | ||||||||
| 119650315 | 11965031 | 2 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | 20 MG, EVERY 1 DAY | 0 | 20 | MG | TABLET | |||||||
| 119650315 | 11965031 | 3 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Oral | UNK | 0 | ||||||||||
| 119650315 | 11965031 | 4 | C | HYDROXYCHLOROQUINE | HYDROXYCHLOROQUINE | 1 | Unknown | UNK | 0 | ||||||||||
| 119650315 | 11965031 | 5 | C | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | 25 MG, QWK | 0 | 25 | MG | /wk | |||||||
| 119650315 | 11965031 | 6 | C | CELEBREX | CELECOXIB | 1 | Oral | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119650315 | 11965031 | 1 | Rheumatoid arthritis |
| 119650315 | 11965031 | 2 | Product used for unknown indication |
| 119650315 | 11965031 | 3 | Rheumatoid arthritis |
| 119650315 | 11965031 | 4 | Product used for unknown indication |
| 119650315 | 11965031 | 5 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119650315 | 11965031 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119650315 | 11965031 | Arthralgia | |
| 119650315 | 11965031 | Drug effect decreased | |
| 119650315 | 11965031 | Drug ineffective | |
| 119650315 | 11965031 | Drug intolerance | |
| 119650315 | 11965031 | Gastrointestinal disorder | |
| 119650315 | 11965031 | Headache | |
| 119650315 | 11965031 | Joint swelling | |
| 119650315 | 11965031 | 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 |
|---|---|---|---|---|---|---|
| 119650315 | 11965031 | 1 | 20151211 | 0 | ||
| 119650315 | 11965031 | 3 | 2013 | 0 | ||
| 119650315 | 11965031 | 5 | 2011 | 0 |