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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125820511 | 12582051 | 1 | I | 20160602 | 20160722 | 20160722 | EXP | DE-ROCHE-1770274 | ROCHE | KLEIN F, NEUHAUS R, EURICH D, HOFMANN J, BAYRAKTAR S, PRATSCHKE J AND BAHRA M. TWO-YEAR FOLLOW-UP ANALYSIS OF TELAPREVIR-BASED ANTIVIRAL TRIPLE THERAPY FOR HCV RECURRENCE IN GENOTYPE 1 INFECTED LIVER GRAFT RECIPIENTS AS A FIRST STEP TOWARDS MODERN HCV THERAPY.. HEPATITIS RESEARCH AND TREATMENT 2016;:-. | 0.00 | Y | 0.00000 | 20160722 | OT | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125820511 | 12582051 | 1 | PS | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | LEAD-IN PHASE OF 4 WEEKS | U | 21511 | |||||||||
| 125820511 | 12582051 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | REDUCED TO 400 MG/DAY OR EVEN 200 MG/DAY, DEPENDING ON THE DEGREE OF CYTOPENIA OR RENAL FUNCTION | U | 21511 | |||||||||
| 125820511 | 12582051 | 3 | SS | Peg-Interferon Alfa 2a | PEGINTERFERON ALFA-2A | 1 | Unknown | U | 103964 | ||||||||||
| 125820511 | 12582051 | 4 | SS | TELAPREVIR | TELAPREVIR | 1 | Unknown | EITHER TWO DAILY DOSES OF 1125 MG OR THREE DAILY DOSES OF 750 MG, RESPECTIVELY | U | 0 | |||||||||
| 125820511 | 12582051 | 5 | C | SANDIMMUN OPTORAL | CYCLOSPORINE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125820511 | 12582051 | 1 | Hepatitis C |
| 125820511 | 12582051 | 3 | Hepatitis C |
| 125820511 | 12582051 | 4 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125820511 | 12582051 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125820511 | 12582051 | Anaemia | |
| 125820511 | 12582051 | Anal pruritus | |
| 125820511 | 12582051 | Clostridium difficile colitis | |
| 125820511 | 12582051 | Leukopenia | |
| 125820511 | 12582051 | Product quality issue | |
| 125820511 | 12582051 | Rash | |
| 125820511 | 12582051 | Renal failure | |
| 125820511 | 12582051 | Urinary tract infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |