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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118938434 | 11893843 | 4 | F | 2015 | 20160630 | 20160107 | 20160711 | EXP | ES-AMGEN-ESPSP2015035949 | AMGEN | 41.00 | YR | A | F | Y | 0.00000 | 20160711 | CN | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118938434 | 11893843 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, WEEKLY | Y | L18677 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||
| 118938434 | 11893843 | 2 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, WEEKLY | Y | L95482 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||
| 118938434 | 11893843 | 3 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, WEEKLY | Y | N09073 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||
| 118938434 | 11893843 | 4 | C | CEMIDON | ISONIAZID | 1 | 300 MG, 1X/DAY | 0 | 300 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118938434 | 11893843 | 1 | Psoriasis |
| 118938434 | 11893843 | 4 | Mycobacterium tuberculosis complex test positive |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118938434 | 11893843 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118938434 | 11893843 | Furuncle | |
| 118938434 | 11893843 | Injection site erythema | |
| 118938434 | 11893843 | Injection site inflammation | |
| 118938434 | 11893843 | Injection site pruritus | |
| 118938434 | 11893843 | Injection site swelling | |
| 118938434 | 11893843 | Injection site urticaria | |
| 118938434 | 11893843 | Injection site warmth | |
| 118938434 | 11893843 | Malaise | |
| 118938434 | 11893843 | Oral fungal infection | |
| 118938434 | 11893843 | Platelet count increased | |
| 118938434 | 11893843 | Pyrexia | |
| 118938434 | 11893843 | Subcutaneous abscess |
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 |
|---|---|---|---|---|---|---|
| 118938434 | 11893843 | 1 | 20150309 | 2015 | 0 | |
| 118938434 | 11893843 | 2 | 201512 | 0 | ||
| 118938434 | 11893843 | 3 | 2016 | 0 |