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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118464443 | 11846444 | 3 | F | 2015 | 20160725 | 20151217 | 20160801 | PER | US-AMGEN-USASL2015134409 | AMGEN | 54.00 | YR | A | M | Y | 117.91000 | KG | 20160731 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118464443 | 11846444 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | 50 MG, TWICE A WEEK | U | 1059239 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | BIW | ||||
| 118464443 | 11846444 | 2 | SS | ENBREL | ETANERCEPT | 1 | Unknown | UNK UNK, WEEKLY | U | 103795 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||||
| 118464443 | 11846444 | 3 | SS | ENBREL | ETANERCEPT | 1 | Unknown | 50 MG, 2 TIMES/WK | U | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | BIW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118464443 | 11846444 | 1 | Psoriasis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118464443 | 11846444 | Device issue | |
| 118464443 | 11846444 | Extra dose administered | |
| 118464443 | 11846444 | Incorrect product storage | |
| 118464443 | 11846444 | Injection site coldness | |
| 118464443 | 11846444 | Injection site pain | |
| 118464443 | 11846444 | Injection site reaction | |
| 118464443 | 11846444 | Intentional product misuse | |
| 118464443 | 11846444 | Pruritus | |
| 118464443 | 11846444 | Sensory disturbance | |
| 118464443 | 11846444 | Underdose | |
| 118464443 | 11846444 | 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 |
|---|---|---|---|---|---|---|
| 118464443 | 11846444 | 1 | 201503 | 0 |