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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125471051 | 12547105 | 1 | I | 20151125 | 20160614 | 20160711 | 20160711 | EXP | GB-GILEAD-2016-0219511 | GILEAD | 49.00 | YR | A | M | Y | 100.00000 | KG | 20160711 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125471051 | 12547105 | 1 | PS | HARVONI | LEDIPASVIRSOFOSBUVIR | 1 | Unknown | 1 DF, QD | 205834 | 1 | DF | TABLET | QD | ||||||
| 125471051 | 12547105 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | 600 MG, QD | 0 | 600 | MG | QD | |||||||
| 125471051 | 12547105 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | 800 MG, QHS | 0 | 800 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125471051 | 12547105 | 1 | Hepatitis C |
| 125471051 | 12547105 | 2 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125471051 | 12547105 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125471051 | 12547105 | Drug ineffective | |
| 125471051 | 12547105 | Hepatocellular carcinoma | |
| 125471051 | 12547105 | Treatment failure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |