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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 86315253 | 8631525 | 3 | F | 2010 | 20160808 | 20120624 | 20160815 | EXP | US-AMGEN-USASP2012038052 | AMGEN | 63.00 | YR | A | F | Y | 0.00000 | 20160815 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 86315253 | 8631525 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | 50 MG, QWK | 1030097 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
| 86315253 | 8631525 | 2 | SS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | 1063617 | 103795 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||||
| 86315253 | 8631525 | 3 | C | ARAVA | LEFLUNOMIDE | 1 | Unknown | 20 MG, QOD | 0 | 20 | MG | QD | |||||||
| 86315253 | 8631525 | 4 | C | PLAQUENIL /00072602/ | HYDROXYCHLOROQUINE DIPHOSPHATE | 1 | Unknown | 200 MG, BID | 0 | 200 | MG | BID | |||||||
| 86315253 | 8631525 | 5 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | UNK UNK, Q2WK | 0 | QOW | |||||||||
| 86315253 | 8631525 | 6 | C | FOSAMAX | ALENDRONATE SODIUM | 1 | 70 MG, QWK | 0 | 70 | MG | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 86315253 | 8631525 | 1 | Rheumatoid arthritis |
| 86315253 | 8631525 | 3 | Rheumatoid arthritis |
| 86315253 | 8631525 | 4 | Rheumatoid arthritis |
| 86315253 | 8631525 | 6 | Bone density abnormal |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 86315253 | 8631525 | OT |
| 86315253 | 8631525 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 86315253 | 8631525 | Arthropathy | |
| 86315253 | 8631525 | Biopsy breast | |
| 86315253 | 8631525 | Breast operation | |
| 86315253 | 8631525 | Device related infection | |
| 86315253 | 8631525 | Drug dose omission | |
| 86315253 | 8631525 | Impaired healing | |
| 86315253 | 8631525 | Mammogram | |
| 86315253 | 8631525 | Nodule | |
| 86315253 | 8631525 | Rheumatoid arthritis | |
| 86315253 | 8631525 | Temporomandibular joint syndrome | |
| 86315253 | 8631525 | Uterine cancer |
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 |
|---|---|---|---|---|---|---|
| 86315253 | 8631525 | 1 | 20080225 | 0 |