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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118422212 | 11842221 | 2 | F | 20151109 | 20160630 | 20151216 | 20160707 | EXP | JP-GILEAD-2015-0185751 | GILEAD | 77.00 | YR | E | F | Y | 48.00000 | KG | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118422212 | 11842221 | 1 | PS | SOVALDI | SOFOSBUVIR | 1 | Oral | 400 MG, QD | 11600 | MG | Y | 204671 | 400 | MG | TABLET | QD | |||
| 118422212 | 11842221 | 2 | SS | COPEGUS | RIBAVIRIN | 1 | Oral | 600 MG, UNK | U | 0 | 600 | MG | TABLET | ||||||
| 118422212 | 11842221 | 3 | C | MAINTATE | BISOPROLOL FUMARATE | 1 | Unknown | UNK | 0 | ||||||||||
| 118422212 | 11842221 | 4 | C | ASPARA /00520101/ | 2 | Unknown | UNK | 0 | |||||||||||
| 118422212 | 11842221 | 5 | C | TOCLASE /00184902/ | 2 | Unknown | UNK | 0 | |||||||||||
| 118422212 | 11842221 | 6 | C | AMLODIN | AMLODIPINE BESYLATE | 1 | Unknown | UNK | 0 | ||||||||||
| 118422212 | 11842221 | 7 | C | DIART | AZOSEMIDE | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118422212 | 11842221 | 1 | Chronic hepatitis C |
| 118422212 | 11842221 | 2 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118422212 | 11842221 | OT |
| 118422212 | 11842221 | HO |
| 118422212 | 11842221 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118422212 | 11842221 | Anaemia | |
| 118422212 | 11842221 | Hepatic encephalopathy | |
| 118422212 | 11842221 | Hyperalbuminaemia | |
| 118422212 | 11842221 | Jaundice | |
| 118422212 | 11842221 | 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 |
|---|---|---|---|---|---|---|
| 118422212 | 11842221 | 1 | 20151026 | 20151124 | 0 | |
| 118422212 | 11842221 | 2 | 20151026 | 20151124 | 0 |