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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126141011 | 12614101 | 1 | I | 20160719 | 20160802 | 20160802 | EXP | PL-ASTELLAS-2016US029403 | ASTELLAS | 22.00 | YR | F | Y | 0.00000 | 20160802 | OT | GB | PL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126141011 | 12614101 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 50708 | FORMULATION UNKNOWN | ||||||||
| 126141011 | 12614101 | 2 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126141011 | 12614101 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126141011 | 12614101 | 4 | C | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | U | 0 | 600 | MG | FORMULATION UNKNOWN | BID | ||||||
| 126141011 | 12614101 | 5 | C | PEG-INTERFERON ALFA 2A | PEGINTERFERON ALFA-2A | 1 | Unknown | 180 ?G/WEEK | U | 0 | 180 | UG | FORMULATION UNKNOWN | ||||||
| 126141011 | 12614101 | 6 | C | PEG-INTERFERON ALFA 2A | PEGINTERFERON ALFA-2A | 1 | Unknown | 135 ?G/WEEK | U | 0 | 135 | UG | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126141011 | 12614101 | 1 | Liver transplant |
| 126141011 | 12614101 | 2 | Liver transplant |
| 126141011 | 12614101 | 3 | Liver transplant |
| 126141011 | 12614101 | 4 | Hepatitis C |
| 126141011 | 12614101 | 5 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126141011 | 12614101 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126141011 | 12614101 | Blood creatinine increased | |
| 126141011 | 12614101 | Cholestasis | |
| 126141011 | 12614101 | Clostridium difficile infection | |
| 126141011 | 12614101 | Complications of transplanted liver | |
| 126141011 | 12614101 | Gastric ulcer | |
| 126141011 | 12614101 | Hepatitis cholestatic | |
| 126141011 | 12614101 | Hypoalbuminaemia | |
| 126141011 | 12614101 | Hypogammaglobulinaemia | |
| 126141011 | 12614101 | Pancytopenia | |
| 126141011 | 12614101 | Toxicity to various agents | |
| 126141011 | 12614101 | Upper respiratory tract infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |