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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125246575 | 12524657 | 5 | F | 2016 | 20160919 | 20160704 | 20160928 | PER | US-AMGEN-USASL2016080279 | AMGEN | 51.00 | YR | A | F | Y | 0.00000 | 20160927 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125246575 | 12524657 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | 50 MG, QWK | Y | 1067962 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||
| 125246575 | 12524657 | 2 | SS | ENBREL | ETANERCEPT | 1 | Unknown | UNK, Q2WK ONCE EVERY TWO WEEKS | Y | 103795 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | QOW | |||||||
| 125246575 | 12524657 | 3 | SS | ENBREL | ETANERCEPT | 1 | Unknown | UNK UNK, QWK | Y | 103795 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||||
| 125246575 | 12524657 | 4 | SS | IBUPROFEN. | IBUPROFEN | 1 | Unknown | 800 MG, QD | 0 | 800 | MG | QD | |||||||
| 125246575 | 12524657 | 5 | SS | IBUPROFEN. | IBUPROFEN | 1 | Unknown | 800 1600 MG | 0 | ||||||||||
| 125246575 | 12524657 | 6 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | UNK | 0 | ||||||||||
| 125246575 | 12524657 | 7 | C | OTEZLA | APREMILAST | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125246575 | 12524657 | 1 | Psoriatic arthropathy |
| 125246575 | 12524657 | 4 | Pain |
| 125246575 | 12524657 | 6 | Product used for unknown indication |
| 125246575 | 12524657 | 7 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125246575 | 12524657 | Arthralgia | |
| 125246575 | 12524657 | Bone swelling | |
| 125246575 | 12524657 | Condition aggravated | |
| 125246575 | 12524657 | Drug dose omission | |
| 125246575 | 12524657 | Drug ineffective | |
| 125246575 | 12524657 | Dyspnoea | |
| 125246575 | 12524657 | Fatigue | |
| 125246575 | 12524657 | Fluid retention | |
| 125246575 | 12524657 | Headache | |
| 125246575 | 12524657 | Hepatic enzyme abnormal | |
| 125246575 | 12524657 | Joint swelling | |
| 125246575 | 12524657 | Liver function test increased | |
| 125246575 | 12524657 | Musculoskeletal chest pain | |
| 125246575 | 12524657 | Nausea | |
| 125246575 | 12524657 | Off label use | |
| 125246575 | 12524657 | Pain | |
| 125246575 | 12524657 | Pain in extremity | |
| 125246575 | 12524657 | Peripheral swelling | |
| 125246575 | 12524657 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 125246575 | 12524657 | 1 | 20160527 | 2016 | 0 | |
| 125246575 | 12524657 | 2 | 2016 | 0 | ||
| 125246575 | 12524657 | 3 | 2016 | 0 | ||
| 125246575 | 12524657 | 4 | 201607 | 0 | ||
| 125246575 | 12524657 | 5 | 2016 | 2016 | 0 |