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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118697092 | 11869709 | 2 | F | 20151109 | 20160708 | 20151228 | 20160713 | EXP | JP-ROCHE-1684581 | ROCHE | 77.00 | YR | F | Y | 48.00000 | KG | 20160713 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118697092 | 11869709 | 1 | PS | COPEGUS | RIBAVIRIN | 1 | Oral | THE FRACTIONATION DOSE FREQUENCY IS UNCERTAIN. | Y | 21511 | 600 | MG | TABLET | ||||||
| 118697092 | 11869709 | 2 | SS | SOVALDI | SOFOSBUVIR | 1 | Oral | Y | 0 | 400 | MG | TABLET | QD | ||||||
| 118697092 | 11869709 | 3 | C | MAINTATE | BISOPROLOL FUMARATE | 1 | Unknown | DOSAGE IS UNCERTAIN. | 0 | ||||||||||
| 118697092 | 11869709 | 4 | C | TOCLASE | PENTOXYVERINE | 1 | Unknown | DOSAGE IS UNCERTAIN. | 0 | ||||||||||
| 118697092 | 11869709 | 5 | C | AMLODIN | AMLODIPINE BESYLATE | 1 | Unknown | DOSAGE IS UNCERTAIN. | 0 | ||||||||||
| 118697092 | 11869709 | 6 | C | DIART | AZOSEMIDE | 1 | Unknown | DOSAGE IS UNCERTAIN. | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118697092 | 11869709 | 1 | Chronic hepatitis C |
| 118697092 | 11869709 | 2 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118697092 | 11869709 | LT |
| 118697092 | 11869709 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118697092 | 11869709 | Anaemia | |
| 118697092 | 11869709 | Hepatic encephalopathy | |
| 118697092 | 11869709 | Hyperalbuminaemia | |
| 118697092 | 11869709 | Jaundice | |
| 118697092 | 11869709 | Renal impairment |
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 |
|---|---|---|---|---|---|---|
| 118697092 | 11869709 | 1 | 20151026 | 20151124 | 0 | |
| 118697092 | 11869709 | 2 | 20151026 | 20151124 | 0 |