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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127091553 | 12709155 | 3 | F | 20160718 | 20160909 | 20160901 | 20160915 | EXP | US-GILEAD-2016-0225507 | GILEAD | 58.00 | YR | A | M | Y | 0.00000 | 20160915 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127091553 | 12709155 | 1 | PS | SOFOSBUVIR | SOFOSBUVIR | 1 | Oral | 400 MG, QD | Y | 204671 | 400 | MG | TABLET | QD | |||||
| 127091553 | 12709155 | 2 | SS | SOFOSBUVIR | SOFOSBUVIR | 1 | Oral | 400 MG, QD | Y | 204671 | 400 | MG | TABLET | QD | |||||
| 127091553 | 12709155 | 3 | SS | RIBASPHERE | RIBAVIRIN | 1 | Oral | UNK | Y | 0 | |||||||||
| 127091553 | 12709155 | 4 | SS | RIBASPHERE | RIBAVIRIN | 1 | Oral | UNK | Y | 0 | |||||||||
| 127091553 | 12709155 | 5 | SS | RIBASPHERE | RIBAVIRIN | 1 | Oral | UNK | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127091553 | 12709155 | 1 | Chronic hepatitis C |
| 127091553 | 12709155 | 3 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127091553 | 12709155 | HO |
| 127091553 | 12709155 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127091553 | 12709155 | Amnesia | |
| 127091553 | 12709155 | Dehydration | |
| 127091553 | 12709155 | Diarrhoea | |
| 127091553 | 12709155 | Disturbance in attention | |
| 127091553 | 12709155 | Dizziness | |
| 127091553 | 12709155 | Drug dose omission | |
| 127091553 | 12709155 | Emotional disorder | |
| 127091553 | 12709155 | Gastrointestinal disorder | |
| 127091553 | 12709155 | Headache | |
| 127091553 | 12709155 | Product availability issue |
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 |
|---|---|---|---|---|---|---|
| 127091553 | 12709155 | 1 | 20160617 | 0 | ||
| 127091553 | 12709155 | 2 | 20160902 | 0 | ||
| 127091553 | 12709155 | 3 | 20160617 | 20160718 | 0 | |
| 127091553 | 12709155 | 4 | 20160719 | 0 |