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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121088505 | 12108850 | 5 | F | 2015 | 20160706 | 20160224 | 20160714 | PER | US-AMGEN-USASP2016020282 | AMGEN | 62.00 | YR | A | F | Y | 0.00000 | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121088505 | 12108850 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | 50 MG, QWK | U | 1065295 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||
| 121088505 | 12108850 | 2 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | UNK | 0 | |||||||||||
| 121088505 | 12108850 | 3 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121088505 | 12108850 | 1 | Systemic lupus erythematosus |
| 121088505 | 12108850 | 3 | Hypothyroidism |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121088505 | 12108850 | Body temperature abnormal | |
| 121088505 | 12108850 | Diarrhoea | |
| 121088505 | 12108850 | Drug dose omission | |
| 121088505 | 12108850 | Incorrect drug administration rate | |
| 121088505 | 12108850 | Infection | |
| 121088505 | 12108850 | Injection site haemorrhage | |
| 121088505 | 12108850 | Injection site pain | |
| 121088505 | 12108850 | Injection site rash | |
| 121088505 | 12108850 | Injection site swelling | |
| 121088505 | 12108850 | Malaise | |
| 121088505 | 12108850 | Off label use | |
| 121088505 | 12108850 | Underdose | |
| 121088505 | 12108850 | Weight decreased | |
| 121088505 | 12108850 | 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 |
|---|---|---|---|---|---|---|
| 121088505 | 12108850 | 1 | 201510 | 0 |