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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117448934 | 11744893 | 4 | F | 2015 | 20160806 | 20151116 | 20160815 | EXP | US-AMGEN-USASP2015120615 | AMGEN | 50.00 | YR | A | F | Y | 0.00000 | 20160815 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117448934 | 11744893 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, WEEKLY | Y | 1058855 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||
| 117448934 | 11744893 | 2 | SS | FISH OIL | FISH OIL | 1 | Unknown | UNK | 0 | ||||||||||
| 117448934 | 11744893 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 117448934 | 11744893 | 4 | C | ARAVA | LEFLUNOMIDE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117448934 | 11744893 | 1 | Product used for unknown indication |
| 117448934 | 11744893 | 2 | Product used for unknown indication |
| 117448934 | 11744893 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117448934 | 11744893 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117448934 | 11744893 | Adverse drug reaction | |
| 117448934 | 11744893 | Drug effect incomplete | |
| 117448934 | 11744893 | Drug ineffective | |
| 117448934 | 11744893 | Dysphagia | |
| 117448934 | 11744893 | Gastrooesophageal reflux disease | |
| 117448934 | 11744893 | Liver function test increased | |
| 117448934 | 11744893 | Respiratory disorder | |
| 117448934 | 11744893 | Salivary gland operation | |
| 117448934 | 11744893 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 117448934 | 11744893 | 1 | 2015 | 0 |