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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111189072 | 11118907 | 2 | F | 20150323 | 20160908 | 20150518 | 20160921 | EXP | PT-INFARMED-N201504-179 | PT-AMGEN-PRTSP2015047109 | AMGEN | 54.00 | YR | A | F | Y | 70.00000 | KG | 20160921 | OT | PT | PT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111189072 | 11118907 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 25 MG, 2X/WEEK | Y | 103795 | 25 | MG | UNKNOWN FORMULATION | BIW | |||||
| 111189072 | 11118907 | 2 | I | HARVONI | LEDIPASVIRSOFOSBUVIR | 1 | Oral | 1 DF, 1X/DAY | 14SFC020UD | 0 | 1 | DF | QD | ||||||
| 111189072 | 11118907 | 3 | I | LEDIPASVIR | LEDIPASVIR | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111189072 | 11118907 | 1 | Psoriatic arthropathy |
| 111189072 | 11118907 | 2 | Hepatitis C |
| 111189072 | 11118907 | 3 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111189072 | 11118907 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111189072 | 11118907 | Drug interaction | |
| 111189072 | 11118907 | Fatigue | |
| 111189072 | 11118907 | Headache | |
| 111189072 | 11118907 | Peripheral swelling |
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 |
|---|---|---|---|---|---|---|
| 111189072 | 11118907 | 1 | 2010 | 0 | ||
| 111189072 | 11118907 | 2 | 20150323 | 0 |