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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119332323 | 11933232 | 3 | F | 20160804 | 20160121 | 20160812 | EXP | CA-AMGEN-CANSP2016004828 | AMGEN | 64.00 | YR | A | F | Y | 0.00000 | 20160812 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119332323 | 11933232 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | UNK | U | 103795 | UNKNOWN FORMULATION | ||||||||
| 119332323 | 11933232 | 2 | SS | PROLIA | DENOSUMAB | 1 | Unknown | UNK | U | 0 | UNKNOWN FORMULATION | ||||||||
| 119332323 | 11933232 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | 20 MG, QWK | 0 | 20 | MG | /wk | |||||||
| 119332323 | 11933232 | 4 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Oral | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 119332323 | 11933232 | 5 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Unknown | UNK | 0 | ||||||||||
| 119332323 | 11933232 | 6 | SS | CELEBREX | CELECOXIB | 1 | Oral | UNK | 0 | CAPSULE | |||||||||
| 119332323 | 11933232 | 7 | SS | ARAVA | LEFLUNOMIDE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 119332323 | 11933232 | 8 | SS | ACTONEL | RISEDRONATE SODIUM | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 119332323 | 11933232 | 9 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Oral | UNK | 0 | ||||||||||
| 119332323 | 11933232 | 10 | SS | PREDNISOL /00016201/ | PREDNISOLONE | 1 | Unknown | UNK | 0 | ||||||||||
| 119332323 | 11933232 | 11 | SS | ORENCIA | ABATACEPT | 1 | Unknown | UNK | 0 | ||||||||||
| 119332323 | 11933232 | 12 | SS | ACTEMRA | TOCILIZUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 119332323 | 11933232 | 13 | SS | SIMPONI | GOLIMUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 119332323 | 11933232 | 14 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | UNK UNK, QWK | 0 | /wk | |||||||||
| 119332323 | 11933232 | 15 | 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 |
|---|---|---|---|
| 119332323 | 11933232 | 1 | Rheumatoid arthritis |
| 119332323 | 11933232 | 2 | Rheumatoid arthritis |
| 119332323 | 11933232 | 3 | Rheumatoid arthritis |
| 119332323 | 11933232 | 4 | Product used for unknown indication |
| 119332323 | 11933232 | 5 | Rheumatoid arthritis |
| 119332323 | 11933232 | 6 | Rheumatoid arthritis |
| 119332323 | 11933232 | 7 | Rheumatoid arthritis |
| 119332323 | 11933232 | 8 | Rheumatoid arthritis |
| 119332323 | 11933232 | 9 | Rheumatoid arthritis |
| 119332323 | 11933232 | 10 | Rheumatoid arthritis |
| 119332323 | 11933232 | 11 | Rheumatoid arthritis |
| 119332323 | 11933232 | 12 | Rheumatoid arthritis |
| 119332323 | 11933232 | 13 | Rheumatoid arthritis |
| 119332323 | 11933232 | 14 | Product used for unknown indication |
| 119332323 | 11933232 | 15 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119332323 | 11933232 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119332323 | 11933232 | Activities of daily living impaired | |
| 119332323 | 11933232 | Arthralgia | |
| 119332323 | 11933232 | Bedridden | |
| 119332323 | 11933232 | Condition aggravated | |
| 119332323 | 11933232 | Drug effect incomplete | |
| 119332323 | 11933232 | Drug ineffective | |
| 119332323 | 11933232 | Foot fracture | |
| 119332323 | 11933232 | General physical health deterioration | |
| 119332323 | 11933232 | Lower limb fracture | |
| 119332323 | 11933232 | Mobility decreased | |
| 119332323 | 11933232 | Osteoporosis | |
| 119332323 | 11933232 | 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 |
|---|---|---|---|---|---|---|
| 119332323 | 11933232 | 3 | 20121104 | 0 | ||
| 119332323 | 11933232 | 4 | 20121104 | 20141206 | 0 | |
| 119332323 | 11933232 | 15 | 20160315 | 0 |