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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125283042 | 12528304 | 2 | F | 2016 | 20160719 | 20160705 | 20160728 | PER | US-AMGEN-USASL2016084758 | AMGEN | 52.00 | YR | A | F | Y | 0.00000 | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125283042 | 12528304 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | UNK UNK, QWK | U | 103795 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||||
| 125283042 | 12528304 | 2 | SS | ENBREL | ETANERCEPT | 1 | Unknown | UNK UNK, EVERY TENTH DAY | U | 103795 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||||
| 125283042 | 12528304 | 3 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 125283042 | 12528304 | 4 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125283042 | 12528304 | 5 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125283042 | 12528304 | 1 | Ankylosing spondylitis |
| 125283042 | 12528304 | 3 | Injection site reaction |
| 125283042 | 12528304 | 4 | Injection site warmth |
| 125283042 | 12528304 | 5 | Injection site pruritus |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125283042 | 12528304 | Alopecia | |
| 125283042 | 12528304 | Arthralgia | |
| 125283042 | 12528304 | Epistaxis | |
| 125283042 | 12528304 | Hypersensitivity | |
| 125283042 | 12528304 | Injection site erythema | |
| 125283042 | 12528304 | Injection site pruritus | |
| 125283042 | 12528304 | Injection site reaction | |
| 125283042 | 12528304 | Injection site swelling | |
| 125283042 | 12528304 | Injection site warmth | |
| 125283042 | 12528304 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 125283042 | 12528304 | 1 | 20160620 | 0 | ||
| 125283042 | 12528304 | 2 | 2016 | 0 |