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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118257436 | 11825743 | 6 | F | 20031014 | 20160725 | 20151211 | 20160802 | EXP | CA-AMGEN-KDL369309 | AMGEN | 47.00 | YR | A | M | Y | 89.00000 | KG | 20160802 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118257436 | 11825743 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | UNK, 2 TIMES/WK | U | 103795 | UNKNOWN FORMULATION | BIW | |||||||
| 118257436 | 11825743 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 118257436 | 11825743 | 3 | SS | ORENCIA | ABATACEPT | 1 | Unknown | UNK | 0 | ||||||||||
| 118257436 | 11825743 | 4 | SS | ARAVA | LEFLUNOMIDE | 1 | Oral | 10 MG, OD, 1 EVERY 1 DAY. | 0 | 10 | MG | TABLET | |||||||
| 118257436 | 11825743 | 5 | SS | ANAKINRA | ANAKINRA | 1 | Unknown | 0 | |||||||||||
| 118257436 | 11825743 | 6 | SS | HYDROXYCHLOROQUINE | HYDROXYCHLOROQUINE | 1 | Unknown | 0 | |||||||||||
| 118257436 | 11825743 | 7 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Subcutaneous | 0 | |||||||||||
| 118257436 | 11825743 | 8 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Oral | UNK | 0 | ||||||||||
| 118257436 | 11825743 | 9 | SS | RITUXIMAB | RITUXIMAB | 1 | Unknown | 0 | |||||||||||
| 118257436 | 11825743 | 10 | C | NAPROSYN | NAPROXEN | 1 | Oral | 500 MG, BID | 0 | 500 | MG | BID | |||||||
| 118257436 | 11825743 | 11 | C | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118257436 | 11825743 | 1 | Rheumatoid arthritis |
| 118257436 | 11825743 | 2 | Product used for unknown indication |
| 118257436 | 11825743 | 3 | Product used for unknown indication |
| 118257436 | 11825743 | 4 | Rheumatoid arthritis |
| 118257436 | 11825743 | 5 | Rheumatoid arthritis |
| 118257436 | 11825743 | 6 | Rheumatoid arthritis |
| 118257436 | 11825743 | 7 | Rheumatoid arthritis |
| 118257436 | 11825743 | 9 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118257436 | 11825743 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118257436 | 11825743 | Abdominal discomfort | |
| 118257436 | 11825743 | Acne cystic | |
| 118257436 | 11825743 | Condition aggravated | |
| 118257436 | 11825743 | Disability | |
| 118257436 | 11825743 | Drug effect decreased | |
| 118257436 | 11825743 | Drug effect incomplete | |
| 118257436 | 11825743 | Drug ineffective | |
| 118257436 | 11825743 | Drug intolerance | |
| 118257436 | 11825743 | Joint stiffness | |
| 118257436 | 11825743 | Musculoskeletal pain | |
| 118257436 | 11825743 | Pain | |
| 118257436 | 11825743 | Rheumatoid arthritis | |
| 118257436 | 11825743 | Sleep disorder |
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 |
|---|---|---|---|---|---|---|
| 118257436 | 11825743 | 1 | 20031014 | 0 |