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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125166053 | 12516605 | 3 | F | 20150914 | 20160902 | 20160630 | 20160912 | EXP | JP-ROCHE-1784889 | ROCHE | 76.00 | YR | F | Y | 57.00000 | KG | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125166053 | 12516605 | 1 | PS | COPEGUS | RIBAVIRIN | 1 | Oral | FRACTIONATION DOSE UNCERTAIN FREQUENCY AND DOSE INTERVAL UNCERTAINTY | 21511 | 400 | MG | TABLET | |||||||
| 125166053 | 12516605 | 2 | SS | SOVALDI | SOFOSBUVIR | 1 | Oral | FRACTIONATION DOSE UNCERTAIN FREQUENCY AND DOSE INTERVAL UNCERTAINTY | 0 | 400 | MG | TABLET | |||||||
| 125166053 | 12516605 | 3 | C | URSO | URSODIOL | 1 | Unknown | DOSAGE IS UNCERTAIN. | 0 | ||||||||||
| 125166053 | 12516605 | 4 | C | GASTER | FAMOTIDINE | 1 | Unknown | DOSAGE IS UNCERTAIN. | 0 | ||||||||||
| 125166053 | 12516605 | 5 | C | LASIX | FUROSEMIDE | 1 | Unknown | DOSAGE IS UNCERTAIN. | 0 | ||||||||||
| 125166053 | 12516605 | 6 | C | NORVASC | AMLODIPINE BESYLATE | 1 | Unknown | DOSAGE IS UNCERTAIN. | 0 | ||||||||||
| 125166053 | 12516605 | 7 | C | BLOPRESS | CANDESARTAN CILEXETIL | 1 | Unknown | DOSAGE IS UNCERTAIN. | 0 | ||||||||||
| 125166053 | 12516605 | 8 | C | LENDORMIN | BROTIZOLAM | 1 | Unknown | DOSAGE IS UNCERTAIN. | 0 | ||||||||||
| 125166053 | 12516605 | 9 | C | ALOSENN | SENNA LEAF | 1 | Unknown | DOSAGE IS UNCERTAIN. | 0 | ||||||||||
| 125166053 | 12516605 | 10 | C | ZACRAS | AMLODIPINE BESYLATEAZILSARTAN | 1 | Unknown | DOSAGE IS UNCERTAIN. | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125166053 | 12516605 | 1 | Chronic hepatitis C |
| 125166053 | 12516605 | 2 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125166053 | 12516605 | DS |
| 125166053 | 12516605 | LT |
| 125166053 | 12516605 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125166053 | 12516605 | Hepatic failure | |
| 125166053 | 12516605 | Hypoproteinaemia | |
| 125166053 | 12516605 | Oedema peripheral | |
| 125166053 | 12516605 | Pleural effusion | |
| 125166053 | 12516605 | Pyrexia | |
| 125166053 | 12516605 | Renal failure |
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 |
|---|---|---|---|---|---|---|
| 125166053 | 12516605 | 1 | 20150817 | 20151109 | 0 | |
| 125166053 | 12516605 | 2 | 20150817 | 20151109 | 0 | |
| 125166053 | 12516605 | 3 | 20021025 | 0 | ||
| 125166053 | 12516605 | 4 | 20060327 | 0 | ||
| 125166053 | 12516605 | 5 | 20130708 | 0 | ||
| 125166053 | 12516605 | 8 | 20060330 | 0 | ||
| 125166053 | 12516605 | 9 | 20150914 | 0 | ||
| 125166053 | 12516605 | 10 | 20071018 | 0 |