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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103950085 | 10395008 | 5 | F | 20140918 | 20160720 | 20140820 | 20160725 | EXP | BR-AMGEN-BRASP2014063372 | AMGEN | 61.00 | YR | A | M | Y | 74.00000 | KG | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103950085 | 10395008 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, ONCE A WEEK | L13407 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
| 103950085 | 10395008 | 2 | SS | MESACOL /00747601/ | MESALAMINE | 1 | Unknown | UNK | 0 | ||||||||||
| 103950085 | 10395008 | 3 | C | MESALAZINE | MESALAMINE | 1 | 1600 MG (2 TABLETS OF 800 MG) DAILY | 0 | 1600 | MG | |||||||||
| 103950085 | 10395008 | 4 | C | MESALAZINE | MESALAMINE | 1 | 0 | ||||||||||||
| 103950085 | 10395008 | 5 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 1 TABLET OF 20 MG DAILY | 0 | 20 | MG | TABLET | ||||||||
| 103950085 | 10395008 | 6 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 103950085 | 10395008 | 1 | Rheumatoid arthritis |
| 103950085 | 10395008 | 2 | Colitis ulcerative |
| 103950085 | 10395008 | 3 | Colitis ulcerative |
| 103950085 | 10395008 | 4 | Colitis ulcerative |
| 103950085 | 10395008 | 5 | Blood cholesterol increased |
| 103950085 | 10395008 | 6 | Blood cholesterol increased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 103950085 | 10395008 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 103950085 | 10395008 | Injection site erythema | |
| 103950085 | 10395008 | Injection site pruritus | |
| 103950085 | 10395008 | Pruritus generalised | |
| 103950085 | 10395008 | Urethral obstruction |
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 |
|---|---|---|---|---|---|---|
| 103950085 | 10395008 | 1 | 20140730 | 0 | ||
| 103950085 | 10395008 | 2 | 1995 | 0 | ||
| 103950085 | 10395008 | 5 | 2010 | 0 |