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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126715161 | 12671516 | 1 | I | 20160818 | 20160822 | 20160822 | EXP | CA-AMGEN-CANSP2016109184 | AMGEN | 5.00 | DEC | F | Y | 0.00000 | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126715161 | 12671516 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | UNK | U | 103795 | UNKNOWN FORMULATION | ||||||||
| 126715161 | 12671516 | 2 | SS | ARAVA | LEFLUNOMIDE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 126715161 | 12671516 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 126715161 | 12671516 | 4 | SS | HYDROXYCHLOROQUINE | HYDROXYCHLOROQUINE | 1 | Unknown | UNK | 0 | ||||||||||
| 126715161 | 12671516 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 126715161 | 12671516 | 6 | SS | ORENCIA | ABATACEPT | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 126715161 | 12671516 | 7 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 126715161 | 12671516 | 8 | SS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 126715161 | 12671516 | 9 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126715161 | 12671516 | 1 | Rheumatoid arthritis |
| 126715161 | 12671516 | 2 | Rheumatoid arthritis |
| 126715161 | 12671516 | 3 | Rheumatoid arthritis |
| 126715161 | 12671516 | 4 | Rheumatoid arthritis |
| 126715161 | 12671516 | 5 | Rheumatoid arthritis |
| 126715161 | 12671516 | 6 | Rheumatoid arthritis |
| 126715161 | 12671516 | 7 | Rheumatoid arthritis |
| 126715161 | 12671516 | 8 | Rheumatoid arthritis |
| 126715161 | 12671516 | 9 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126715161 | 12671516 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126715161 | 12671516 | Breast cancer stage III | |
| 126715161 | 12671516 | Depression | |
| 126715161 | 12671516 | Diarrhoea | |
| 126715161 | 12671516 | Rheumatoid arthritis | |
| 126715161 | 12671516 | Sleep disorder | |
| 126715161 | 12671516 | Treatment noncompliance |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |