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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125494172 | 12549417 | 2 | F | 20150520 | 20160722 | 20160712 | 20160726 | EXP | IT-GILEAD-2016-0221881 | GILEAD | 58.00 | YR | A | M | Y | 76.00000 | KG | 20160726 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125494172 | 12549417 | 1 | PS | SOVALDI | SOFOSBUVIR | 1 | Oral | 400 MG, QD | 45200 | MG | 204671 | 400 | MG | TABLET | QD | ||||
| 125494172 | 12549417 | 2 | SS | REBETOL | RIBAVIRIN | 1 | Oral | 1000 MG, QD | 113000 | MG | 0 | 1000 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125494172 | 12549417 | 1 | Chronic hepatitis C |
| 125494172 | 12549417 | 2 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125494172 | 12549417 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125494172 | 12549417 | Hepatic lesion | |
| 125494172 | 12549417 | Hepatocellular carcinoma |
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 |
|---|---|---|---|---|---|---|
| 125494172 | 12549417 | 1 | 20150127 | 20150715 | 0 | |
| 125494172 | 12549417 | 2 | 20150127 | 20150715 | 0 |