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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127678071 | 12767807 | 1 | I | 199807 | 20160901 | 20160921 | 20160921 | EXP | FR-ASTELLAS-2016US036291 | ASTELLAS | DUMORTIER J, GUULLAUD O, BOSCH A, COPPERE B, PETIOT P, ROGGERONE S ET AL. PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY AFTER LIVER TRANSPLANTATION CAN HAVE FAVORABLE OR UNFAVORABLE OUTCOME. TRANSPLANT INFECTIOUS DISEASE. 2016;18(4):606-10 | 36.00 | YR | F | Y | 0.00000 | 20160921 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127678071 | 12767807 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | U | 50708 | 3 | MG | FORMULATION UNKNOWN | QD | ||||||
| 127678071 | 12767807 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0.25 MG, ONCE DAILY | D | 50708 | .25 | MG | FORMULATION UNKNOWN | QD | |||||
| 127678071 | 12767807 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | D | 50708 | 1 | MG | FORMULATION UNKNOWN | QD | ||||||
| 127678071 | 12767807 | 4 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | U | 0 | 5 | MG | FORMULATION UNKNOWN | QD | ||||||
| 127678071 | 12767807 | 5 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | U | 0 | 1000 | MG | FORMULATION UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127678071 | 12767807 | 1 | Liver transplant |
| 127678071 | 12767807 | 4 | Liver transplant |
| 127678071 | 12767807 | 5 | Liver transplant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127678071 | 12767807 | DE |
| 127678071 | 12767807 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127678071 | 12767807 | Hepatic failure | |
| 127678071 | 12767807 | JC virus infection | |
| 127678071 | 12767807 | Progressive multifocal leukoencephalopathy | |
| 127678071 | 12767807 | Transplant rejection |
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 |
|---|---|---|---|---|---|---|
| 127678071 | 12767807 | 2 | 201009 | 0 |