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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124874113 | 12487411 | 3 | F | 2016 | 20160824 | 20160622 | 20160919 | PER | US-AMGEN-USASL2016078844 | AMGEN | 54.00 | YR | A | F | Y | 0.00000 | 20160918 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124874113 | 12487411 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | 50 MG, QWK | U | 1067265 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||
| 124874113 | 12487411 | 2 | SS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | U | 1065294 | 103795 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 124874113 | 12487411 | 3 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | UNK | 0 | ||||||||||
| 124874113 | 12487411 | 4 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | 9 QD UNK | 0 | QD | ||||||||||
| 124874113 | 12487411 | 5 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | 9 ONE OR TWO DAY | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124874113 | 12487411 | 1 | Rheumatoid arthritis |
| 124874113 | 12487411 | 3 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124874113 | 12487411 | Fibromyalgia | |
| 124874113 | 12487411 | Injection site erythema | |
| 124874113 | 12487411 | Injection site inflammation | |
| 124874113 | 12487411 | Injection site pain | |
| 124874113 | 12487411 | Injection site rash | |
| 124874113 | 12487411 | Injection site reaction | |
| 124874113 | 12487411 | Injection site swelling | |
| 124874113 | 12487411 | Injection site warmth | |
| 124874113 | 12487411 | Malaise | |
| 124874113 | 12487411 | Pain | |
| 124874113 | 12487411 | Therapeutic response unexpected | |
| 124874113 | 12487411 | Visual acuity reduced |
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 |
|---|---|---|---|---|---|---|
| 124874113 | 12487411 | 1 | 20160603 | 0 | ||
| 124874113 | 12487411 | 3 | 2016 | 0 | ||
| 124874113 | 12487411 | 4 | 1991 | 0 |