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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115147743 | 11514774 | 3 | F | 20150419 | 20160921 | 20150916 | 20160923 | EXP | PT-INFARMED-L201508-138 | PT-GILEAD-2015-0171937 | GILEAD | 40.00 | YR | A | M | Y | 69.00000 | KG | 20160923 | PH | PT | PT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115147743 | 11514774 | 1 | PS | HARVONI | LEDIPASVIRSOFOSBUVIR | 1 | Oral | VALIDADE: 30-11-2016. SUSPENS?O POR T?RMINO DO TRATAMENTO. | 3 | DF | D | 14SFC021UD | 205834 | 1 | DF | TABLET | QD | ||
| 115147743 | 11514774 | 2 | SS | COPEGUS | RIBAVIRIN | 1 | Oral | VALIDADE: 31-10-2017. | Y | N2049B04 | 0 | 1200 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115147743 | 11514774 | 1 | Chronic hepatitis C |
| 115147743 | 11514774 | 2 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115147743 | 11514774 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115147743 | 11514774 | Dry skin | |
| 115147743 | 11514774 | Erythema | |
| 115147743 | 11514774 | Insomnia | |
| 115147743 | 11514774 | Rash | |
| 115147743 | 11514774 | Rash pruritic |
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 |
|---|---|---|---|---|---|---|
| 115147743 | 11514774 | 1 | 20150416 | 20150708 | 0 | |
| 115147743 | 11514774 | 2 | 20150416 | 20150610 | 0 |