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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114494574 | 11449457 | 4 | F | 201508 | 20160630 | 20150903 | 20160708 | EXP | CA-AMGEN-CANSP2015089436 | AMGEN | 52.00 | YR | A | F | Y | 0.00000 | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114494574 | 11449457 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | U | 103795 | UNKNOWN FORMULATION | ||||||||
| 114494574 | 11449457 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | 40 MG, UNK | 0 | 40 | MG | ||||||||
| 114494574 | 11449457 | 3 | SS | METHOTREXATE (METHOTREXATE SODIUM) | METHOTREXATE SODIUM | 1 | Oral | 25 MG, QWK | 0 | 25 | MG | /wk | |||||||
| 114494574 | 11449457 | 4 | SS | METHOTREXATE (METHOTREXATE SODIUM) | METHOTREXATE SODIUM | 1 | Oral | 2.5 MG, QWK,EVERY TUESDAY 5 TABLETS ONCE A WEEK | 0 | 2.5 | MG | /wk | |||||||
| 114494574 | 11449457 | 5 | SS | METHOTREXATE (METHOTREXATE SODIUM) | METHOTREXATE SODIUM | 1 | Oral | 2.5 MG, QWK, EVERY WEDNESDAY (5 TABLETS/WEEK) FOR 90 DAYS | 0 | 2.5 | MG | /wk | |||||||
| 114494574 | 11449457 | 6 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 114494574 | 11449457 | 7 | SS | ACTEMRA | TOCILIZUMAB | 1 | Unknown | 4 MG/KG, UNK | 0 | 4 | MG/KG | ||||||||
| 114494574 | 11449457 | 8 | SS | IBUPROFEN. | IBUPROFEN | 1 | Oral | 600 MG, TID, FOR 60 DAYS | 0 | 600 | MG | TABLET | TID | ||||||
| 114494574 | 11449457 | 9 | SS | IBUPROFEN. | IBUPROFEN | 1 | 0 | TABLET | |||||||||||
| 114494574 | 11449457 | 10 | SS | NAPROXEN. | NAPROXEN | 1 | Oral | 500 MG, BID, FOR 90 DAYS | 0 | 500 | MG | TABLET | BID | ||||||
| 114494574 | 11449457 | 11 | SS | NAPROXEN. | NAPROXEN | 1 | Oral | 750 MG, BID, FOR 90 DAYS | 0 | 750 | MG | TABLET | BID | ||||||
| 114494574 | 11449457 | 12 | SS | FOLIC ACID. | FOLIC ACID | 1 | Oral | 5 MG, QWK, EVERY WEDNESDAY FOR 90 DAYS | 0 | 5 | MG | /wk | |||||||
| 114494574 | 11449457 | 13 | SS | FOLIC ACID. | FOLIC ACID | 1 | Oral | 5 MG, QWK,EVERY FRIDAY FOR 90 DAYS | 0 | 5 | MG | /wk | |||||||
| 114494574 | 11449457 | 14 | SS | PARIET | RABEPRAZOLE SODIUM | 1 | Oral | 20 MG, QD, FOR 90 DAYS | 0 | 20 | MG | TABLET | QD | ||||||
| 114494574 | 11449457 | 15 | SS | PARIET | RABEPRAZOLE SODIUM | 1 | Oral | 20 MG, QD, FOR 90 DAYS | 0 | 20 | MG | TABLET | QD | ||||||
| 114494574 | 11449457 | 16 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Oral | 40 MG, UNK | 0 | 40 | MG | INJECTION | |||||||
| 114494574 | 11449457 | 17 | SS | NAPROSYN | NAPROXEN | 1 | Oral | 500 MG, QD, FOR 90 DAYS | 0 | 500 | MG | TABLET | QD | ||||||
| 114494574 | 11449457 | 18 | SS | NAPROSYN | NAPROXEN | 1 | Oral | 500 MG, BID, FOR 90 DAYS | 0 | 500 | MG | TABLET | BID | ||||||
| 114494574 | 11449457 | 19 | SS | RITUXAN | RITUXIMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 114494574 | 11449457 | 20 | C | RABEPRAZOLE SODIUM. | RABEPRAZOLE SODIUM | 1 | Oral | 20 MG, UNK | 0 | 20 | MG | ||||||||
| 114494574 | 11449457 | 21 | 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 |
|---|---|---|---|
| 114494574 | 11449457 | 1 | Rheumatoid arthritis |
| 114494574 | 11449457 | 2 | Rheumatoid arthritis |
| 114494574 | 11449457 | 3 | Rheumatoid arthritis |
| 114494574 | 11449457 | 6 | Rheumatoid arthritis |
| 114494574 | 11449457 | 7 | Product used for unknown indication |
| 114494574 | 11449457 | 8 | Rheumatoid arthritis |
| 114494574 | 11449457 | 9 | Arthralgia |
| 114494574 | 11449457 | 10 | Product used for unknown indication |
| 114494574 | 11449457 | 12 | Product used for unknown indication |
| 114494574 | 11449457 | 14 | Product used for unknown indication |
| 114494574 | 11449457 | 16 | Product used for unknown indication |
| 114494574 | 11449457 | 17 | Rheumatoid arthritis |
| 114494574 | 11449457 | 19 | Rheumatoid arthritis |
| 114494574 | 11449457 | 21 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114494574 | 11449457 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114494574 | 11449457 | Blood alkaline phosphatase increased | |
| 114494574 | 11449457 | Condition aggravated | |
| 114494574 | 11449457 | Drug hypersensitivity | |
| 114494574 | 11449457 | Drug ineffective | |
| 114494574 | 11449457 | Erythema | |
| 114494574 | 11449457 | Joint swelling | |
| 114494574 | 11449457 | Mouth ulceration | |
| 114494574 | 11449457 | Nasal ulcer | |
| 114494574 | 11449457 | Obesity | |
| 114494574 | 11449457 | Pain | |
| 114494574 | 11449457 | Rheumatoid arthritis | |
| 114494574 | 11449457 | Stress | |
| 114494574 | 11449457 | Swelling |
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 |
|---|---|---|---|---|---|---|
| 114494574 | 11449457 | 2 | 201001 | 201008 | 0 | |
| 114494574 | 11449457 | 3 | 200910 | 201205 | 0 | |
| 114494574 | 11449457 | 4 | 20131015 | 0 | ||
| 114494574 | 11449457 | 5 | 20140613 | 0 | ||
| 114494574 | 11449457 | 6 | 200910 | 201302 | 0 | |
| 114494574 | 11449457 | 7 | 201301 | 201310 | 0 | |
| 114494574 | 11449457 | 8 | 20140514 | 0 | ||
| 114494574 | 11449457 | 10 | 20140613 | 0 | ||
| 114494574 | 11449457 | 11 | 20140925 | 0 | ||
| 114494574 | 11449457 | 12 | 20131015 | 0 | ||
| 114494574 | 11449457 | 13 | 20140613 | 0 | ||
| 114494574 | 11449457 | 14 | 20131015 | 0 | ||
| 114494574 | 11449457 | 15 | 20140613 | 0 | ||
| 114494574 | 11449457 | 16 | 20140409 | 0 | ||
| 114494574 | 11449457 | 17 | 20130702 | 0 | ||
| 114494574 | 11449457 | 18 | 20130702 | 0 | ||
| 114494574 | 11449457 | 21 | 20150907 | 0 |