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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104256644 | 10425664 | 4 | F | 2012 | 20160720 | 20140903 | 20160728 | EXP | BR-AMGEN-BRASP2013010225 | AMGEN | 53.00 | YR | A | F | Y | 70.00000 | KG | 20160728 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104256644 | 10425664 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, WEEKLY | G024631 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
| 104256644 | 10425664 | 2 | SS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | G79072 | 103795 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||||
| 104256644 | 10425664 | 3 | C | PREDNISONE. | PREDNISONE | 1 | 5 MG, 2X/DAY | 0 | 5 | MG | BID | ||||||||
| 104256644 | 10425664 | 4 | C | PREDNISONE. | PREDNISONE | 1 | 5 MG, 2X/DAY | 0 | 5 | MG | BID | ||||||||
| 104256644 | 10425664 | 5 | C | CHLOROQUINE. | CHLOROQUINE | 1 | 400 MG, 2X/DAY | 0 | 400 | MG | BID | ||||||||
| 104256644 | 10425664 | 6 | C | MACRODANTIN | NITROFURANTOIN | 1 | 100 MG, 1X/DAY | 0 | 100 | MG | QD | ||||||||
| 104256644 | 10425664 | 7 | C | MACRODANTIN | NITROFURANTOIN | 1 | UNK | 0 | |||||||||||
| 104256644 | 10425664 | 8 | C | METHOTREXATE. | METHOTREXATE | 1 | 10 MG (4 TABLETS OF 2.5 MG), WEEKLY | 0 | 10 | MG | /wk | ||||||||
| 104256644 | 10425664 | 9 | C | FOLIC ACID. | FOLIC ACID | 1 | 5 MG, 1X/DAY | 0 | 5 | MG | QD | ||||||||
| 104256644 | 10425664 | 10 | C | FOLIC ACID. | FOLIC ACID | 1 | 5 MG, 1X/DAY | 0 | 5 | MG | QD | ||||||||
| 104256644 | 10425664 | 11 | C | DEFLAZACORT | DEFLAZACORT | 1 | UNK | 0 | |||||||||||
| 104256644 | 10425664 | 12 | C | TRILEPTAL | OXCARBAZEPINE | 1 | Subcutaneous | 300 MG, ONCE A WEEK | 0 | 300 | MG | /wk | |||||||
| 104256644 | 10425664 | 13 | C | TRILEPTAL | OXCARBAZEPINE | 1 | 300 MG, WEEKLY | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 104256644 | 10425664 | 1 | Rheumatoid arthritis |
| 104256644 | 10425664 | 5 | Rheumatoid arthritis |
| 104256644 | 10425664 | 6 | Urinary tract infection |
| 104256644 | 10425664 | 7 | Renal disorder |
| 104256644 | 10425664 | 8 | Rheumatoid arthritis |
| 104256644 | 10425664 | 9 | Liver disorder |
| 104256644 | 10425664 | 11 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 104256644 | 10425664 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 104256644 | 10425664 | Brain neoplasm benign | |
| 104256644 | 10425664 | Injection site erythema | |
| 104256644 | 10425664 | Injection site haematoma | |
| 104256644 | 10425664 | Injection site hypersensitivity | |
| 104256644 | 10425664 | Injection site pruritus | |
| 104256644 | 10425664 | Injection site rash | |
| 104256644 | 10425664 | Injection site swelling | |
| 104256644 | 10425664 | Pain | |
| 104256644 | 10425664 | 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 |
|---|---|---|---|---|---|---|
| 104256644 | 10425664 | 1 | 2011 | 0 | ||
| 104256644 | 10425664 | 5 | 2012 | 0 | ||
| 104256644 | 10425664 | 8 | 2012 | 0 | ||
| 104256644 | 10425664 | 11 | 201305 | 0 |