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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125633351 | 12563335 | 1 | I | 20130529 | 20160706 | 20160715 | 20160715 | EXP | PHHY2016IT094765 | SANDOZ | 29.00 | YR | M | Y | 0.00000 | 20160715 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125633351 | 12563335 | 1 | PS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 800 MG, QD | 56800 | MG | Y | U | 76192 | 800 | MG | QD | |||
| 125633351 | 12563335 | 2 | SS | TELAPREVIR | TELAPREVIR | 1 | Oral | 2250 MG, QD | Y | U | 0 | 2250 | MG | TABLET | QD | ||||
| 125633351 | 12563335 | 3 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | 1.5 UG/KG, QW | Y | U | 0 | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125633351 | 12563335 | 1 | Chronic hepatitis C |
| 125633351 | 12563335 | 2 | Chronic hepatitis C |
| 125633351 | 12563335 | 3 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125633351 | 12563335 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125633351 | 12563335 | Fatigue | |
| 125633351 | 12563335 | Insomnia | |
| 125633351 | 12563335 | Leukopenia | |
| 125633351 | 12563335 | Musculoskeletal pain | |
| 125633351 | 12563335 | Prurigo | |
| 125633351 | 12563335 | Pyrexia | |
| 125633351 | 12563335 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125633351 | 12563335 | 1 | 20130522 | 20131218 | 0 | |
| 125633351 | 12563335 | 2 | 20130924 | 0 | ||
| 125633351 | 12563335 | 3 | 20130522 | 20131218 | 0 |