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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124525002 | 12452500 | 2 | F | 20160811 | 20160609 | 20160816 | EXP | US-JNJFOC-20160607075 | JANSSEN | SAXENA V, KORAISHY FM, SISE ME, LIM JK, SCHMIDT M, CHUNG RT, ET AL. SAFETY AND EFFICACY OF SOFOSBUVIR-CONTAINING REGIMENS IN HEPATITIS C-INFECTED PATIENTS WITH IMPAIRED RENAL FUNCTION. LIVER INTERNATIONAL 2016;36:807-816. | 0.00 | Y | 0.00000 | 20160816 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124525002 | 12452500 | 1 | PS | SIMEPREVIR | SIMEPREVIR | 1 | Unknown | U | UNKNOWN | 205123 | CAPSULE | ||||||||
| 124525002 | 12452500 | 2 | SS | SOFOSBUVIR | SOFOSBUVIR | 1 | Unknown | 0 | 400 | MG | UNKNOWN | ||||||||
| 124525002 | 12452500 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | 0 | 800 | MG | UNKNOWN | ||||||||
| 124525002 | 12452500 | 4 | C | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124525002 | 12452500 | 5 | C | CYCLOSPORIN | CYCLOSPORINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124525002 | 12452500 | 6 | C | EVEROLIMUS | EVEROLIMUS | 1 | Unknown | 0 | |||||||||||
| 124525002 | 12452500 | 7 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124525002 | 12452500 | 1 | Hepatitis C |
| 124525002 | 12452500 | 2 | Hepatitis C |
| 124525002 | 12452500 | 3 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124525002 | 12452500 | DE |
| 124525002 | 12452500 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124525002 | 12452500 | Adverse event | |
| 124525002 | 12452500 | Anaemia | |
| 124525002 | 12452500 | Cardiac disorder | |
| 124525002 | 12452500 | Death | |
| 124525002 | 12452500 | Fatigue | |
| 124525002 | 12452500 | Headache | |
| 124525002 | 12452500 | Nausea | |
| 124525002 | 12452500 | Off label use | |
| 124525002 | 12452500 | Product use issue | |
| 124525002 | 12452500 | Remission not achieved | |
| 124525002 | 12452500 | Renal impairment |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |