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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125608842 | 12560884 | 2 | F | 20130706 | 20160720 | 20160715 | 20160727 | EXP | CA-AMGEN-CANSP2015105337 | AMGEN | 41.00 | YR | A | F | Y | 0.00000 | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125608842 | 12560884 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, QWK | U | 103795 | 50 | MG | UNKNOWN FORMULATION | /wk | |||||
| 125608842 | 12560884 | 2 | SS | ARAVA | LEFLUNOMIDE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 125608842 | 12560884 | 3 | SS | CELEBREX | CELECOXIB | 1 | Unknown | UNK | 0 | CAPSULE | |||||||||
| 125608842 | 12560884 | 4 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | 20 MG, QD | 0 | 20 | MG | TABLET | QD | ||||||
| 125608842 | 12560884 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | Oral | 20 MG, QWK | 0 | 20 | MG | /wk | |||||||
| 125608842 | 12560884 | 6 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | 200 MG, BID | 0 | 200 | MG | TABLET | BID | ||||||
| 125608842 | 12560884 | 7 | SS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | 50 MG, CYCLICAL | 0 | 50 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125608842 | 12560884 | 1 | Rheumatoid arthritis |
| 125608842 | 12560884 | 2 | Rheumatoid arthritis |
| 125608842 | 12560884 | 3 | Arthritis |
| 125608842 | 12560884 | 4 | Rheumatoid arthritis |
| 125608842 | 12560884 | 5 | Rheumatoid arthritis |
| 125608842 | 12560884 | 6 | Rheumatoid arthritis |
| 125608842 | 12560884 | 7 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125608842 | 12560884 | DS |
| 125608842 | 12560884 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125608842 | 12560884 | Activities of daily living impaired | |
| 125608842 | 12560884 | Condition aggravated | |
| 125608842 | 12560884 | Drug ineffective | |
| 125608842 | 12560884 | Dysstasia | |
| 125608842 | 12560884 | Gastrointestinal disorder | |
| 125608842 | 12560884 | Malaise | |
| 125608842 | 12560884 | Migraine | |
| 125608842 | 12560884 | Mobility decreased | |
| 125608842 | 12560884 | Nausea | |
| 125608842 | 12560884 | Pain | |
| 125608842 | 12560884 | Rheumatoid arthritis | |
| 125608842 | 12560884 | 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 |
|---|---|---|---|---|---|---|
| 125608842 | 12560884 | 1 | 201211 | 20140314 | 0 | |
| 125608842 | 12560884 | 4 | 20110107 | 0 | ||
| 125608842 | 12560884 | 5 | 20091120 | 201311 | 0 | |
| 125608842 | 12560884 | 6 | 20100219 | 201311 | 0 | |
| 125608842 | 12560884 | 7 | 201404 | 201509 | 0 |