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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123222293 | 12322229 | 3 | F | 20160705 | 20160502 | 20160715 | EXP | JP-009507513-1504JPN020679 | MERCK | 52.00 | YR | M | Y | 85.00000 | KG | 20160715 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123222293 | 12322229 | 1 | PS | REBETOL | RIBAVIRIN | 1 | Oral | 500 MG, QD | Y | 20903 | 500 | MG | CAPSULE | QD | |||||
| 123222293 | 12322229 | 2 | SS | REBETOL | RIBAVIRIN | 1 | Oral | 300 MG, QD | Y | 20903 | 300 | MG | CAPSULE | QD | |||||
| 123222293 | 12322229 | 3 | SS | REBETOL | RIBAVIRIN | 1 | Oral | 100 MG, QD | Y | 20903 | 100 | MG | CAPSULE | QD | |||||
| 123222293 | 12322229 | 4 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | 1.5 MICROGRAM PER KILOGRAM1.5 MICROGRAM/KG(130 MICROGRAM), QW | Y | 0 | 1.5 | UG/KG | POWDER FOR INJECTION | /wk | |||||
| 123222293 | 12322229 | 5 | SS | TELAVIC | TELAPREVIR | 1 | Oral | 500 MG, TID, AFTER EACH MEAL, FOR 12 WEEKS | 0 | 500 | MG | TID | |||||||
| 123222293 | 12322229 | 6 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 123222293 | 12322229 | 7 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | Unknown | REDUCED TO 25% OF THE ORIGINAL DOSE, MAINTAIN A TROUGH LEVEL OF 100 TO 150 NG/ML | U | 0 | |||||||||
| 123222293 | 12322229 | 8 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | Unknown | INCREASED TO 200 TO 250 NG/ML | U | 0 | |||||||||
| 123222293 | 12322229 | 9 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 1000 MG, UNK | U | 0 | |||||||||
| 123222293 | 12322229 | 10 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | DAILY 2000 MG | U | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123222293 | 12322229 | 1 | Hepatitis C |
| 123222293 | 12322229 | 4 | Hepatitis C |
| 123222293 | 12322229 | 5 | Hepatitis C |
| 123222293 | 12322229 | 6 | Immunosuppression |
| 123222293 | 12322229 | 9 | Immunosuppression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123222293 | 12322229 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123222293 | 12322229 | Anaemia | |
| 123222293 | 12322229 | Autoimmune hepatitis | |
| 123222293 | 12322229 | Drug interaction | |
| 123222293 | 12322229 | Incorrect dose administered | |
| 123222293 | 12322229 | Off label use | |
| 123222293 | 12322229 | Rash | |
| 123222293 | 12322229 | Renal impairment | |
| 123222293 | 12322229 | Transplant rejection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |