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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117846797 | 11784679 | 7 | F | 2015 | 20160421 | 20151130 | 20160810 | PER | US-AMGEN-USASL2015124897 | AMGEN | 54.00 | YR | A | F | Y | 0.00000 | 20160809 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117846797 | 11784679 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | 50 MG, ONCE WEEKLY | U | 1062648 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117846797 | 11784679 | 1 | Ankylosing spondylitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117846797 | 11784679 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117846797 | 11784679 | Adverse drug reaction | |
| 117846797 | 11784679 | Ankylosing spondylitis | |
| 117846797 | 11784679 | Device issue | |
| 117846797 | 11784679 | Device malfunction | |
| 117846797 | 11784679 | Device use error | |
| 117846797 | 11784679 | Drug ineffective | |
| 117846797 | 11784679 | Feeling abnormal | |
| 117846797 | 11784679 | Fibromyalgia | |
| 117846797 | 11784679 | Headache | |
| 117846797 | 11784679 | Injection site bruising | |
| 117846797 | 11784679 | Injection site discolouration | |
| 117846797 | 11784679 | Injection site erythema | |
| 117846797 | 11784679 | Injection site mass | |
| 117846797 | 11784679 | Injection site pain | |
| 117846797 | 11784679 | Injection site reaction | |
| 117846797 | 11784679 | Malaise | |
| 117846797 | 11784679 | Migraine | |
| 117846797 | 11784679 | Nausea | |
| 117846797 | 11784679 | Rheumatoid arthritis | |
| 117846797 | 11784679 | Underdose | |
| 117846797 | 11784679 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 117846797 | 11784679 | 1 | 20151122 | 201603 | 0 |