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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126250851 | 12625085 | 1 | I | 20160610 | 20160804 | 20160805 | 20160805 | EXP | IT-ROCHE-1809433 | ROCHE | 51.57 | YR | F | Y | 0.00000 | 20160805 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126250851 | 12625085 | 1 | PS | COPEGUS | RIBAVIRIN | 1 | Oral | 200 MG FILM-COATED TABLETS 42 TABLETS IN A BOTTLE | Y | 21511 | 800 | MG | FILM-COATED TABLET | QD | |||||
| 126250851 | 12625085 | 2 | SS | VIEKIRAX | OMBITASVIRPARITAPREVIRRITONAVIR | 1 | Oral | 12.5 MG / 75 MG / 50 MG -56 TABLETS | Y | 0 | 25 | MG | FILM-COATED TABLET | QD | |||||
| 126250851 | 12625085 | 3 | SS | EXVIERA | DASABUVIR | 1 | Oral | 250 MG -BLISTER PACK (PVC/PE/PCTFE/AL)- 56 TABLETS | Y | 0 | 500 | MG | FILM-COATED TABLET | QD | |||||
| 126250851 | 12625085 | 4 | C | XANAX | ALPRAZOLAM | 1 | Unknown | 0.50 MG TABLETS' 20 TABLETS | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126250851 | 12625085 | 1 | Chronic hepatitis C |
| 126250851 | 12625085 | 2 | Chronic hepatitis C |
| 126250851 | 12625085 | 3 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126250851 | 12625085 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126250851 | 12625085 | Asthenia | |
| 126250851 | 12625085 | Diarrhoea | |
| 126250851 | 12625085 | Hepatitis cholestatic |
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 |
|---|---|---|---|---|---|---|
| 126250851 | 12625085 | 1 | 20160520 | 20160610 | 0 | |
| 126250851 | 12625085 | 2 | 20160520 | 20160610 | 0 | |
| 126250851 | 12625085 | 3 | 20160520 | 20160610 | 0 |