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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116888382 | 11688838 | 2 | F | 20160728 | 20151102 | 20160805 | EXP | CA-AMGEN-CANSP2015113541 | AMGEN | 70.00 | YR | E | M | Y | 120.50000 | KG | 20160805 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116888382 | 11688838 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, QWK | Y | 103795 | 50 | MG | UNKNOWN FORMULATION | /wk | |||||
| 116888382 | 11688838 | 2 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 116888382 | 11688838 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | 40 MG, Q2WK | 0 | 40 | MG | QOW | |||||||
| 116888382 | 11688838 | 4 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 116888382 | 11688838 | 5 | C | LYRICA | PREGABALIN | 1 | UNK | 0 | |||||||||||
| 116888382 | 11688838 | 6 | C | METHOTREXATE. | METHOTREXATE | 1 | 25 MG, QWK | 0 | 25 | MG | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116888382 | 11688838 | 1 | Rheumatoid arthritis |
| 116888382 | 11688838 | 2 | Product used for unknown indication |
| 116888382 | 11688838 | 3 | Rheumatoid arthritis |
| 116888382 | 11688838 | 4 | Diabetes mellitus |
| 116888382 | 11688838 | 5 | Pain |
| 116888382 | 11688838 | 6 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116888382 | 11688838 | OT |
| 116888382 | 11688838 | HO |
| 116888382 | 11688838 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116888382 | 11688838 | Apparent death | |
| 116888382 | 11688838 | Arthropathy | |
| 116888382 | 11688838 | Bone marrow failure | |
| 116888382 | 11688838 | Condition aggravated | |
| 116888382 | 11688838 | Diabetes mellitus | |
| 116888382 | 11688838 | Drug hypersensitivity | |
| 116888382 | 11688838 | Drug ineffective | |
| 116888382 | 11688838 | Drug interaction | |
| 116888382 | 11688838 | Exercise tolerance decreased | |
| 116888382 | 11688838 | Musculoskeletal disorder | |
| 116888382 | 11688838 | Oedema peripheral | |
| 116888382 | 11688838 | Pain | |
| 116888382 | 11688838 | Rash |
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 |
|---|---|---|---|---|---|---|
| 116888382 | 11688838 | 1 | 201307 | 201503 | 0 | |
| 116888382 | 11688838 | 2 | 20031202 | 20150404 | 0 | |
| 116888382 | 11688838 | 3 | 201505 | 20151021 | 0 | |
| 116888382 | 11688838 | 6 | 20020624 | 0 |