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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126034974 | 12603497 | 4 | F | 20160805 | 20160728 | 20160812 | EXP | CA-GILEAD-2016-0225005 | GILEAD | 68.00 | YR | E | M | Y | 0.00000 | 20160812 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126034974 | 12603497 | 1 | PS | SOFOSBUVIR | SOFOSBUVIR | 1 | Oral | 400 MG, UNK | 204671 | 400 | MG | TABLET | |||||||
| 126034974 | 12603497 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 1200 MG, UNK | 0 | 1200 | MG | ||||||||
| 126034974 | 12603497 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 1200 UNK, UNK | 0 | 1200 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126034974 | 12603497 | 1 | Chronic hepatitis C |
| 126034974 | 12603497 | 2 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126034974 | 12603497 | HO |
| 126034974 | 12603497 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126034974 | 12603497 | Anaemia | |
| 126034974 | 12603497 | Haemoglobin decreased | |
| 126034974 | 12603497 | Hepatic cirrhosis | |
| 126034974 | 12603497 | Malaise | |
| 126034974 | 12603497 | Transfusion |
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 |
|---|---|---|---|---|---|---|
| 126034974 | 12603497 | 2 | 20160725 | 0 |