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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125877612 | 12587761 | 2 | F | 20160729 | 20160725 | 20160803 | EXP | IR-ASTELLAS-2016US027861 | ASTELLAS | 67.00 | YR | M | Y | 0.00000 | 20160803 | OT | GB | IR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125877612 | 12587761 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | U | 50708 | 1 | MG | FORMULATION UNKNOWN | BID | ||||||
| 125877612 | 12587761 | 2 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | U | 0 | 5 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125877612 | 12587761 | 3 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | U | 0 | 1 | G | FORMULATION UNKNOWN | BID | ||||||
| 125877612 | 12587761 | 4 | C | ALEMTUZUMAB | ALEMTUZUMAB | 1 | Unknown | 30 MG, UNKNOWN FREQ. AS A SINGLE DOSE | U | 0 | 30 | MG | FORMULATION UNKNOWN | ||||||
| 125877612 | 12587761 | 5 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 500 MG, ONCE DAILY FOR 3 DAYS | U | 0 | 500 | MG | FORMULATION UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125877612 | 12587761 | 1 | Renal transplant |
| 125877612 | 12587761 | 2 | Renal transplant |
| 125877612 | 12587761 | 3 | Renal transplant |
| 125877612 | 12587761 | 4 | Immune tolerance induction |
| 125877612 | 12587761 | 5 | Immune tolerance induction |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125877612 | 12587761 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125877612 | 12587761 | Complications of transplanted kidney | |
| 125877612 | 12587761 | Cytomegalovirus infection | |
| 125877612 | 12587761 | Escherichia infection | |
| 125877612 | 12587761 | Simplex virus test positive |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |