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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125351872 | 12535187 | 2 | F | 20150928 | 20160722 | 20160707 | 20160726 | EXP | IT-009507513-1607ITA001339 | MERCK | 55.00 | YR | M | Y | 77.00000 | KG | 20160726 | CN | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125351872 | 12535187 | 1 | PS | REBETOL | RIBAVIRIN | 1 | Oral | 1200 MG DAILY | 20903 | CAPSULE | QD | ||||||||
| 125351872 | 12535187 | 2 | SS | HARVONI | LEDIPASVIRSOFOSBUVIR | 1 | Oral | 1 DOSE UNIT (90 MG + 400 MG) DAILY | 85 | DF | 0 | 1 | DF | FILM-COATED TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125351872 | 12535187 | 1 | Chronic hepatitis C |
| 125351872 | 12535187 | 2 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125351872 | 12535187 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125351872 | 12535187 | Hepatic lesion | |
| 125351872 | 12535187 | Hepatocellular carcinoma |
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 |
|---|---|---|---|---|---|---|
| 125351872 | 12535187 | 1 | 20150706 | 20151220 | 0 | |
| 125351872 | 12535187 | 2 | 20150706 | 20151220 | 0 |