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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114219436 | 11421943 | 6 | F | 2015 | 20160831 | 20150827 | 20160909 | PER | US-AMGEN-USASL2015087797 | AMGEN | 60.00 | YR | A | M | Y | 0.00000 | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114219436 | 11421943 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | 50 MG, QWK | Y | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
| 114219436 | 11421943 | 2 | SS | ENBREL | ETANERCEPT | 1 | Unknown | UNK, QWK | Y | 1055190 | 103795 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||||
| 114219436 | 11421943 | 3 | SS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | Y | 1057020 | 103795 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 114219436 | 11421943 | 4 | SS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | Y | 1067961 | 103795 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 114219436 | 11421943 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 114219436 | 11421943 | 6 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 114219436 | 11421943 | 7 | C | METHOTREXATE. | METHOTREXATE | 1 | UNK | 0 | |||||||||||
| 114219436 | 11421943 | 8 | C | OTEZLA | APREMILAST | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114219436 | 11421943 | 1 | Psoriatic arthropathy |
| 114219436 | 11421943 | 2 | Psoriasis |
| 114219436 | 11421943 | 5 | Product used for unknown indication |
| 114219436 | 11421943 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114219436 | 11421943 | OT |
| 114219436 | 11421943 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114219436 | 11421943 | Ankle operation | |
| 114219436 | 11421943 | Blood pressure decreased | |
| 114219436 | 11421943 | Blood pressure increased | |
| 114219436 | 11421943 | Coronary artery bypass | |
| 114219436 | 11421943 | Decreased immune responsiveness | |
| 114219436 | 11421943 | Discomfort | |
| 114219436 | 11421943 | Drug effect incomplete | |
| 114219436 | 11421943 | Fatigue | |
| 114219436 | 11421943 | Feeling abnormal | |
| 114219436 | 11421943 | Headache | |
| 114219436 | 11421943 | Hepatic enzyme increased | |
| 114219436 | 11421943 | Hypersensitivity | |
| 114219436 | 11421943 | Infection | |
| 114219436 | 11421943 | Injection site bruising | |
| 114219436 | 11421943 | Injection site coldness | |
| 114219436 | 11421943 | Injection site haemorrhage | |
| 114219436 | 11421943 | Injection site pain | |
| 114219436 | 11421943 | Lethargy | |
| 114219436 | 11421943 | Malaise | |
| 114219436 | 11421943 | Mobility decreased | |
| 114219436 | 11421943 | Nasopharyngitis | |
| 114219436 | 11421943 | Psoriasis | |
| 114219436 | 11421943 | Psoriatic arthropathy | |
| 114219436 | 11421943 | Sinus disorder | |
| 114219436 | 11421943 | Sinusitis | |
| 114219436 | 11421943 | Skin plaque | |
| 114219436 | 11421943 | Sleep disorder due to a general medical condition | |
| 114219436 | 11421943 | Viral infection |
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 |
|---|---|---|---|---|---|---|
| 114219436 | 11421943 | 1 | 20141001 | 0 | ||
| 114219436 | 11421943 | 2 | 20160210 | 0 |