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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122788424 | 12278842 | 4 | F | 2015 | 20160628 | 20160418 | 20160705 | EXP | US-AMGEN-USASL2016045860 | AMGEN | 33.00 | YR | A | F | Y | 0.00000 | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122788424 | 12278842 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | 50 MG, QWK | U | 1061829 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||
| 122788424 | 12278842 | 2 | SS | ENBREL | ETANERCEPT | 1 | Unknown | 50 MG, 2 TIMES/WK | U | 1061829 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | BIW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122788424 | 12278842 | 1 | Psoriasis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122788424 | 12278842 | OT |
| 122788424 | 12278842 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122788424 | 12278842 | Cellulitis | |
| 122788424 | 12278842 | Cervix cerclage procedure | |
| 122788424 | 12278842 | Hospitalisation | |
| 122788424 | 12278842 | Maternal exposure during pregnancy | |
| 122788424 | 12278842 | Mental disorder | |
| 122788424 | 12278842 | Off label use | |
| 122788424 | 12278842 | Peripheral venous disease | |
| 122788424 | 12278842 | Psoriasis | |
| 122788424 | 12278842 | Sepsis | |
| 122788424 | 12278842 | Vaginal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 122788424 | 12278842 | 1 | 2013 | 0 | ||
| 122788424 | 12278842 | 2 | 201512 | 0 |