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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111225284 | 11122528 | 4 | F | 20150401 | 20160920 | 20150519 | 20160923 | EXP | PT-INFARMED-L201504-99 | PT-GILEAD-2015-0153557 | GILEAD | 40.00 | YR | A | F | Y | 79.00000 | KG | 20160923 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111225284 | 11122528 | 1 | PS | HARVONI | LEDIPASVIRSOFOSBUVIR | 1 | Oral | 1 DF, QD | 14SFC020UD | 205834 | 1 | DF | TABLET | QD | |||||
| 111225284 | 11122528 | 2 | SS | REBETOL | RIBAVIRIN | 1 | Oral | 1200 MG, QD | 3RCJA72A01 | 0 | 1200 | MG | QD | ||||||
| 111225284 | 11122528 | 3 | C | TRUVADA | EMTRICITABINETENOFOVIR DISOPROXIL FUMARATE | 1 | Oral | 1 DF, QD | DESCONHECIDO | 0 | 1 | DF | TABLET | QD | |||||
| 111225284 | 11122528 | 4 | C | ESOMEPRAZOL /01479301/ | ESOMEPRAZOLE | 1 | Oral | 0 | 40 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111225284 | 11122528 | 1 | Chronic hepatitis C |
| 111225284 | 11122528 | 2 | Chronic hepatitis C |
| 111225284 | 11122528 | 3 | Hepatitis B |
| 111225284 | 11122528 | 4 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111225284 | 11122528 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111225284 | 11122528 | Headache | |
| 111225284 | 11122528 | Nausea | |
| 111225284 | 11122528 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 111225284 | 11122528 | 1 | 20150401 | 0 | ||
| 111225284 | 11122528 | 2 | 20150401 | 0 | ||
| 111225284 | 11122528 | 3 | 20060223 | 0 |