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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 91858134 | 9185813 | 4 | F | 20130227 | 20160913 | 20130325 | 20160924 | EXP | JP-AMGEN-JPNSP2013019278 | AMGEN | 0.00 | F | Y | 0.00000 | 20160924 | CN | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 91858134 | 9185813 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, CYCLIC ONCE EVERY 2 WEEKS | N | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 91858134 | 9185813 | 2 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 25 MG, CYCLIC ONCE EVERY 2 WEEKS | N | 103795 | 25 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 91858134 | 9185813 | 1 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 91858134 | 9185813 | OT |
| 91858134 | 9185813 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 91858134 | 9185813 | Balance disorder | |
| 91858134 | 9185813 | Chronic inflammatory demyelinating polyradiculoneuropathy | |
| 91858134 | 9185813 | Condition aggravated | |
| 91858134 | 9185813 | Dizziness | |
| 91858134 | 9185813 | Hypoaesthesia | |
| 91858134 | 9185813 | Sensory disturbance | |
| 91858134 | 9185813 | Sensory loss |
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 |
|---|---|---|---|---|---|---|
| 91858134 | 9185813 | 1 | 20130226 | 0 |