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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125402501 | 12540250 | 1 | I | 20160629 | 20160708 | 20160708 | EXP | JP-009507513-1607JPN001258 | MERCK | 59.00 | YR | M | Y | 68.00000 | KG | 20160708 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125402501 | 12540250 | 1 | PS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | 90 MICROGRAM, QW | Y | 103949 | 90 | UG | POWDER FOR INJECTION | /wk | |||||
| 125402501 | 12540250 | 2 | SS | REBETOL | RIBAVIRIN | 1 | Oral | 400 MG, QD | Y | 0 | 400 | MG | CAPSULE | QD | |||||
| 125402501 | 12540250 | 3 | SS | TELAVIC | TELAPREVIR | 1 | Unknown | 500 MG, TID | Y | 0 | 500 | MG | TABLET | TID | |||||
| 125402501 | 12540250 | 4 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | Unknown | DAILY DOSAGE UNKNOWN | U | 0 | |||||||||
| 125402501 | 12540250 | 5 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 500 MG, QD; DIVIDED DOSE FREQUENCY UNKNOWN | U | 0 | 500 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125402501 | 12540250 | 1 | Hepatitis C |
| 125402501 | 12540250 | 2 | Hepatitis C |
| 125402501 | 12540250 | 3 | Hepatitis C |
| 125402501 | 12540250 | 4 | Immunosuppression |
| 125402501 | 12540250 | 5 | Immunosuppression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125402501 | 12540250 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125402501 | 12540250 | Anaemia | |
| 125402501 | 12540250 | Drug interaction | |
| 125402501 | 12540250 | Incorrect dose administered | |
| 125402501 | 12540250 | Off label use | |
| 125402501 | 12540250 | Renal impairment | |
| 125402501 | 12540250 | Viral load increased | |
| 125402501 | 12540250 | Viral mutation identified |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |