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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109550524 | 10955052 | 4 | F | 2011 | 20160425 | 20150325 | 20160728 | EXP | JP-009507513-1503JPN000143 | MERCK | 60.00 | YR | F | Y | 43.00000 | KG | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109550524 | 10955052 | 1 | PS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | 70 MICROGRAM, WEEKLY | 103949 | 70 | UG | POWDER FOR INJECTION | /wk | ||||||
| 109550524 | 10955052 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 400 MG, QD | U | 0 | 400 | MG | CAPSULE | QD | |||||
| 109550524 | 10955052 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 400 UNK, UNK | U | 0 | 400 | MG | CAPSULE | QD | |||||
| 109550524 | 10955052 | 4 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 400 MG, QD | U | 0 | 400 | MG | CAPSULE | QD | |||||
| 109550524 | 10955052 | 5 | SS | REBETOL | RIBAVIRIN | 1 | Oral | 400 MG, QD | 0 | 400 | MG | CAPSULE | QD | ||||||
| 109550524 | 10955052 | 6 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | UNK | U | 0 | SUSPENSION FOR INJECTION | |||||||||
| 109550524 | 10955052 | 7 | SS | FERON | INTERFERON BETA | 1 | Intravenous (not otherwise specified) | 6 (MILLION-BILLION UNIT), QD | 0 | INJECTION | QD | ||||||||
| 109550524 | 10955052 | 8 | SS | FERON | INTERFERON BETA | 1 | Intravenous (not otherwise specified) | 6 (MILLION-BILLION UNIT), QD | U | 0 | INJECTION | QD | |||||||
| 109550524 | 10955052 | 9 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | DAILY DOSE UNKNOWN (FORMULATION: POR) | U | 0 | |||||||||
| 109550524 | 10955052 | 10 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | Oral | DAILY DOSE UNNOWN | U | 0 | CAPSULE | ||||||||
| 109550524 | 10955052 | 11 | C | MITIGLINIDE CALCIUM HYDRATE | MITIGLINIDE CALCIUM HYDRATE | 1 | Oral | DAILY DOSAGE UNKNOWN, IMMEDIATELY BEFORE MEAL | 0 | TABLET | |||||||||
| 109550524 | 10955052 | 12 | C | INSULIN ASPART | INSULIN ASPART | 1 | Parenteral | 4 DF, TID (4 DOSE UNDER 1000UNITS) | 0 | 4 | DF | INJECTION | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109550524 | 10955052 | 1 | Hepatitis C |
| 109550524 | 10955052 | 2 | Hepatitis C |
| 109550524 | 10955052 | 3 | Hepatitis C RNA positive |
| 109550524 | 10955052 | 4 | Hepatitis C RNA positive |
| 109550524 | 10955052 | 5 | Hepatitis C |
| 109550524 | 10955052 | 6 | Immunosuppression |
| 109550524 | 10955052 | 7 | Hepatitis C |
| 109550524 | 10955052 | 8 | Hepatitis C RNA positive |
| 109550524 | 10955052 | 9 | Immunosuppressant drug therapy |
| 109550524 | 10955052 | 10 | Immunosuppressant drug therapy |
| 109550524 | 10955052 | 11 | Diabetes mellitus |
| 109550524 | 10955052 | 12 | Diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109550524 | 10955052 | OT |
| 109550524 | 10955052 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109550524 | 10955052 | Liver disorder | |
| 109550524 | 10955052 | Post procedural infection | |
| 109550524 | 10955052 | Procalcitonin increased | |
| 109550524 | 10955052 | Renal impairment | |
| 109550524 | 10955052 | Shock |
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 |
|---|---|---|---|---|---|---|
| 109550524 | 10955052 | 1 | 2010 | 0 | ||
| 109550524 | 10955052 | 2 | 201004 | 0 | ||
| 109550524 | 10955052 | 3 | 201012 | 0 | ||
| 109550524 | 10955052 | 4 | 201012 | 0 | ||
| 109550524 | 10955052 | 5 | 2010 | 0 | ||
| 109550524 | 10955052 | 6 | 2010 | 0 | ||
| 109550524 | 10955052 | 7 | 201004 | 0 | ||
| 109550524 | 10955052 | 8 | 201012 | 0 | ||
| 109550524 | 10955052 | 9 | 2010 | 201012 | 0 | |
| 109550524 | 10955052 | 10 | 201012 | 0 |