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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 92436613 | 9243661 | 3 | F | 2011 | 20160722 | 20130422 | 20160728 | EXP | BR-AMGEN-BRASP2012047017 | AMGEN | 66.00 | YR | E | F | Y | 45.00000 | KG | 20160728 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 92436613 | 9243661 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, ONCE WEEKLY | G30365 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
| 92436613 | 9243661 | 2 | SS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | F95872 | 103795 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||||
| 92436613 | 9243661 | 3 | SS | ENBREL | ETANERCEPT | 1 | Unknown | 25 MG, 2X/WEEK MONDAYS AND THURSDAYS | 103795 | 25 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | BIW | ||||||
| 92436613 | 9243661 | 4 | SS | ENBREL | ETANERCEPT | 1 | Unknown | UNK (STRENGTH 25 MG) | 103795 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||||
| 92436613 | 9243661 | 5 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 20 MG, 1 TABLET IN A FASTED STATE | 0 | 20 | MG | TABLET | ||||||||
| 92436613 | 9243661 | 6 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 | TABLET | |||||||||||
| 92436613 | 9243661 | 7 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 20 MG, 1X/DAY AT NIGHT | 0 | 20 | MG | TABLET | QD | |||||||
| 92436613 | 9243661 | 8 | C | PREDNISONE. | PREDNISONE | 1 | STRENGTH 5MG, UNK | 0 | |||||||||||
| 92436613 | 9243661 | 9 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | STRENGTH 80, UNIT NOT PROVIDED, UNK | 0 | |||||||||||
| 92436613 | 9243661 | 10 | C | CALCIUM CARBONATE. | CALCIUM CARBONATE | 1 | STRENGTH 1250, UNIT NOT PROVIDED, UNK | 0 | |||||||||||
| 92436613 | 9243661 | 11 | C | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | STRENGTH 70MG, UNK | 0 | |||||||||||
| 92436613 | 9243661 | 12 | C | FOLIC ACID. | FOLIC ACID | 1 | STRENGTH 5MG, UNK | 0 | |||||||||||
| 92436613 | 9243661 | 13 | C | METHOTREXATE. | METHOTREXATE | 1 | STRENGTH 2.5MG, UNK | 0 | |||||||||||
| 92436613 | 9243661 | 14 | C | METICORTEN | PREDNISONE | 1 | 10 MG, 1X/DAY 5 MG: 2 TABLETS IN THE MORNING | 0 | 10 | MG | QD | ||||||||
| 92436613 | 9243661 | 15 | C | PARACETAMOL | ACETAMINOPHEN | 1 | 500 MG 1 TABLET A DAY (SHE USUALLY TAKES IT IN THE MORNING) | 0 | 500 | MG | |||||||||
| 92436613 | 9243661 | 16 | C | AMYTRIL | AMITRIPTYLINE HYDROCHLORIDE | 1 | 25 MG, DAILY IN THE MORNING | 0 | 25 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 92436613 | 9243661 | 1 | Rheumatoid arthritis |
| 92436613 | 9243661 | 5 | Gastrointestinal disorder |
| 92436613 | 9243661 | 6 | Gastrointestinal disorder |
| 92436613 | 9243661 | 7 | Blood cholesterol abnormal |
| 92436613 | 9243661 | 8 | Pain |
| 92436613 | 9243661 | 9 | Diabetes mellitus |
| 92436613 | 9243661 | 13 | Arthritis |
| 92436613 | 9243661 | 15 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 92436613 | 9243661 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 92436613 | 9243661 | Bursitis | |
| 92436613 | 9243661 | Diabetes mellitus | |
| 92436613 | 9243661 | Erythema | |
| 92436613 | 9243661 | Injection site pain | |
| 92436613 | 9243661 | Osteoporosis | |
| 92436613 | 9243661 | Pain | |
| 92436613 | 9243661 | Pruritus | |
| 92436613 | 9243661 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 92436613 | 9243661 | 1 | 200809 | 0 | ||
| 92436613 | 9243661 | 3 | 20081029 | 0 |