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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125548002 | 12554800 | 2 | F | 201511 | 20160711 | 20160713 | 20160720 | EXP | FR-GILEAD-2016-0222289 | GILEAD | 50.00 | YR | A | M | Y | 80.00000 | KG | 20160720 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125548002 | 12554800 | 1 | PS | LEDIPASVIR/SOFOSBUVIR | LEDIPASVIRSOFOSBUVIR | 1 | Unknown | 1 DF, QD | 94 | DF | 205834 | 1 | DF | TABLET | QD | ||||
| 125548002 | 12554800 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | 600 MG, BID | 112800 | MG | 0 | 600 | MG | BID | |||||
| 125548002 | 12554800 | 3 | C | LASILIX /00032601/ | FUROSEMIDE | 1 | 0 | ||||||||||||
| 125548002 | 12554800 | 4 | C | DIFFU K | POTASSIUM CHLORIDE | 1 | 0 | ||||||||||||
| 125548002 | 12554800 | 5 | C | INEXIUM /01479302/ | ESOMEPRAZOLE MAGNESIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125548002 | 12554800 | 1 | Hepatitis C |
| 125548002 | 12554800 | 2 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125548002 | 12554800 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125548002 | 12554800 | Drug ineffective | |
| 125548002 | 12554800 | Hepatitis C | |
| 125548002 | 12554800 | Viral mutation identified |
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 |
|---|---|---|---|---|---|---|
| 125548002 | 12554800 | 1 | 20150608 | 20150910 | 0 | |
| 125548002 | 12554800 | 2 | 20150608 | 20150910 | 0 |