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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125316951 | 12531695 | 1 | I | 20160216 | 20160627 | 20160706 | 20160706 | PER | US-GILEAD-2016-0221150 | GILEAD | 60.00 | YR | A | M | Y | 0.00000 | 20160706 | PH | US | US |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125316951 | 12531695 | 1 | PS | HARVONI | LEDIPASVIRSOFOSBUVIR | 1 | Oral | 1 DF, QD | 84 | DF | 205834 | 1 | DF | TABLET | QD | ||||
125316951 | 12531695 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | U | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125316951 | 12531695 | 1 | Hepatitis C |
125316951 | 12531695 | 2 | Hepatitis C |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
125316951 | 12531695 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125316951 | 12531695 | Drug ineffective | |
125316951 | 12531695 | Virologic 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 |
---|---|---|---|---|---|---|
125316951 | 12531695 | 1 | 20151124 | 20160216 | 0 |