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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124446462 | 12444646 | 2 | F | 20151008 | 20160708 | 20160607 | 20160712 | EXP | DE-GILEAD-2016-0203666 | GILEAD | 59.00 | YR | A | M | Y | 79.80000 | KG | 20160712 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124446462 | 12444646 | 1 | PS | LEDIPASVIR/SOFOSBUVIR | LEDIPASVIRSOFOSBUVIR | 1 | Oral | 1 DF, QD | 167 | DF | U | 205834 | 1 | DF | TABLET | QD | |||
| 124446462 | 12444646 | 2 | SS | COPEGUS | RIBAVIRIN | 1 | Oral | 1200 MG, QD | 206400 | MG | U | 0 | 1200 | MG | QD | ||||
| 124446462 | 12444646 | 3 | C | FENISTIL | DIMETHINDENE | 1 | Unknown | 0 | |||||||||||
| 124446462 | 12444646 | 4 | C | METHADONE | METHADONE HYDROCHLORIDE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124446462 | 12444646 | 1 | Chronic hepatitis C |
| 124446462 | 12444646 | 2 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124446462 | 12444646 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124446462 | 12444646 | Oedema peripheral | |
| 124446462 | 12444646 | Pruritus | |
| 124446462 | 12444646 | Respiratory distress | |
| 124446462 | 12444646 | Sense of oppression |
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 |
|---|---|---|---|---|---|---|
| 124446462 | 12444646 | 1 | 20150219 | 20150805 | 0 | |
| 124446462 | 12444646 | 2 | 20150219 | 20150810 | 0 |