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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111053315 | 11105331 | 5 | F | 20150320 | 20160817 | 20150512 | 20160822 | EXP | PT-GILEAD-2015-0145402 | GILEAD | 55.00 | YR | A | M | Y | 105.00000 | KG | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111053315 | 11105331 | 1 | PS | SOVALDI | SOFOSBUVIR | 1 | Oral | 400 MG, UNK | U | 204671 | 400 | MG | TABLET | ||||||
| 111053315 | 11105331 | 2 | SS | SOVALDI | SOFOSBUVIR | 1 | UNK | U | 204671 | TABLET | |||||||||
| 111053315 | 11105331 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 1200 MG, UNK | U | 0 | 1200 | MG | |||||||
| 111053315 | 11105331 | 4 | SS | SIMEPREVIR | SIMEPREVIR | 1 | Oral | 15 MG, UNK | U | 0 | 15 | MG | |||||||
| 111053315 | 11105331 | 5 | C | DACLATASVIR. | DACLATASVIR | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111053315 | 11105331 | 1 | Chronic hepatitis C |
| 111053315 | 11105331 | 3 | Chronic hepatitis C |
| 111053315 | 11105331 | 4 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111053315 | 11105331 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111053315 | 11105331 | Fungal skin infection | |
| 111053315 | 11105331 | Mycosis fungoides | |
| 111053315 | 11105331 | Rash |
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 |
|---|---|---|---|---|---|---|
| 111053315 | 11105331 | 1 | 20150122 | 20150707 | 0 | |
| 111053315 | 11105331 | 2 | 20150122 | 20150707 | 0 | |
| 111053315 | 11105331 | 3 | 20150120 | 0 | ||
| 111053315 | 11105331 | 4 | 20150122 | 20150707 | 0 | |
| 111053315 | 11105331 | 5 | 20150120 | 0 |