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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125471831 | 12547183 | 1 | I | 20160614 | 20160706 | 20160711 | 20160711 | EXP | IT-GILEAD-2016-0222370 | GILEAD | 59.00 | YR | A | F | Y | 70.00000 | KG | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125471831 | 12547183 | 1 | PS | SOVALDI | SOFOSBUVIR | 1 | Oral | 1 DF, QD | 167 | DF | 204671 | 1 | DF | TABLET | QD | ||||
| 125471831 | 12547183 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 5 DF, QD | 835 | DF | 0 | 5 | DF | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125471831 | 12547183 | 1 | Hepatitis C |
| 125471831 | 12547183 | 2 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125471831 | 12547183 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125471831 | 12547183 | Drug ineffective | |
| 125471831 | 12547183 | Hepatitis C | |
| 125471831 | 12547183 | Hepatitis C RNA increased |
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 |
|---|---|---|---|---|---|---|
| 125471831 | 12547183 | 1 | 20151009 | 20160324 | 0 | |
| 125471831 | 12547183 | 2 | 20151009 | 20160324 | 0 |