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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125731301 | 12573130 | 1 | I | 20160607 | 20160706 | 20160720 | 20160720 | EXP | IT-AUROBINDO-AUR-APL-2016-09018 | AUROBINDO | 67.66 | YR | F | Y | 0.00000 | 20160720 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125731301 | 12573130 | 1 | PS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 1000 MG, DAILY | U | 79111 | 1000 | MG | |||||||
| 125731301 | 12573130 | 2 | SS | HARVONI | LEDIPASVIRSOFOSBUVIR | 1 | Oral | 1 DF, DAILY | U | 0 | 1 | DF |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125731301 | 12573130 | 1 | Hepatitis C |
| 125731301 | 12573130 | 2 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125731301 | 12573130 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125731301 | 12573130 | Anaemia | |
| 125731301 | 12573130 | Asthenia |
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 |
|---|---|---|---|---|---|---|
| 125731301 | 12573130 | 1 | 20160510 | 0 | ||
| 125731301 | 12573130 | 2 | 20160510 | 0 |