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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126733592 | 12673359 | 2 | F | 20160830 | 20160822 | 20160906 | EXP | AT-ASTELLAS-2016US032089 | ASTELLAS | BOESMUELLER C, MAGLIONE M, MARGREITER C, DZIODZIOT, BIEBL M, PRATSCHKE J ET AL. SUCCESSFUL COMBINED PANCREAS FOURTH-KIDNEY THIRD AND PANCREAS THIRD-KIDNEY SECOND TRANSPLANTATION: A CASE REPORT. TRANSPLANTATION DIRECT. 2015;1(6):E22 | 47.00 | YR | F | Y | 0.00000 | 20160906 | MD | AT | AT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126733592 | 12673359 | 1 | PS | Advagraf | TACROLIMUS | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 204096 | MODIFIED-RELEASE CAPSULE, HARD | ||||||||
| 126733592 | 12673359 | 2 | SS | Advagraf | TACROLIMUS | 1 | 204096 | MODIFIED-RELEASE CAPSULE, HARD | |||||||||||
| 126733592 | 12673359 | 3 | SS | ALEMTUZUMAB | ALEMTUZUMAB | 1 | Intravenous (not otherwise specified) | U | 0 | 30 | MG | FORMULATION UNKNOWN | |||||||
| 126733592 | 12673359 | 4 | SS | ALEMTUZUMAB | ALEMTUZUMAB | 1 | 0 | FORMULATION UNKNOWN | |||||||||||
| 126733592 | 12673359 | 5 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | U | 0 | 500 | MG | FORMULATION UNKNOWN | |||||||
| 126733592 | 12673359 | 6 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | 0 | FORMULATION UNKNOWN | |||||||||||
| 126733592 | 12673359 | 7 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 15 MG, UNKNOWN FREQ., FOR 3-6 MONTHS | U | 0 | 15 | MG | FORMULATION UNKNOWN | ||||||
| 126733592 | 12673359 | 8 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 5 MG, UNKNOWN FREQ., FOR 7-9 MONTHS | U | 0 | 5 | MG | FORMULATION UNKNOWN | ||||||
| 126733592 | 12673359 | 9 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 5 MG, UNKNOWN FREQ., FOR 10-12 MONTHS | U | 0 | 5 | MG | FORMULATION UNKNOWN | ||||||
| 126733592 | 12673359 | 10 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 5/2.5 MG, ALTERNATE DAYS., FOR 2-3 YEAR | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126733592 | 12673359 | 11 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 2.5 MG ,EVERY 2 DAYS, FOR }3 YEAR | U | 0 | 2.5 | MG | FORMULATION UNKNOWN | ||||||
| 126733592 | 12673359 | 12 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 1000 MG, UNKNOWN FREQ, FOR 3-6 MONTHS | U | 0 | 1000 | MG | FORMULATION UNKNOWN | ||||||
| 126733592 | 12673359 | 13 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 500 MG, UNKNOWN FREQ, FOR 7-9 MONTHS | U | 0 | 500 | MG | FORMULATION UNKNOWN | ||||||
| 126733592 | 12673359 | 14 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 500 MG, UNKNOWN FREQ., FOR 10-12 MONTHS | U | 0 | 500 | MG | FORMULATION UNKNOWN | ||||||
| 126733592 | 12673359 | 15 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 500 MG, UNKNOWN FREQ., FOR 2-3 YEAR | U | 0 | 500 | MG | FORMULATION UNKNOWN | ||||||
| 126733592 | 12673359 | 16 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 500 MG, UNKNOWN FREQ., FOR }3 YEARS | U | 0 | 500 | MG | FORMULATION UNKNOWN | ||||||
| 126733592 | 12673359 | 17 | SS | ATG /00575401/ | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126733592 | 12673359 | 18 | SS | ATG /00575401/ | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | 0 | FORMULATION UNKNOWN | |||||||||||
| 126733592 | 12673359 | 19 | C | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126733592 | 12673359 | 20 | C | VALGANCICLOVIR. | VALGANCICLOVIR | 1 | Unknown | UNK UNK, UNKNOWN FREQ., UNTIL 6 MONTHS | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126733592 | 12673359 | 21 | C | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126733592 | 12673359 | 22 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126733592 | 12673359 | 23 | C | ACETYLCYSTEINE. | ACETYLCYSTEINE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126733592 | 12673359 | 24 | C | TMP | 2 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126733592 | 12673359 | 1 | Pancreas transplant |
| 126733592 | 12673359 | 2 | Renal and pancreas transplant |
| 126733592 | 12673359 | 3 | Pancreas transplant |
| 126733592 | 12673359 | 4 | Renal and pancreas transplant |
| 126733592 | 12673359 | 5 | Pancreas transplant |
| 126733592 | 12673359 | 6 | Renal and pancreas transplant |
| 126733592 | 12673359 | 7 | Pancreas transplant |
| 126733592 | 12673359 | 8 | Renal and pancreas transplant |
| 126733592 | 12673359 | 12 | Renal and pancreas transplant |
| 126733592 | 12673359 | 13 | Renal and liver transplant |
| 126733592 | 12673359 | 17 | Renal and liver transplant |
| 126733592 | 12673359 | 18 | Renal and liver transplant |
| 126733592 | 12673359 | 19 | Product used for unknown indication |
| 126733592 | 12673359 | 20 | Product used for unknown indication |
| 126733592 | 12673359 | 21 | Product used for unknown indication |
| 126733592 | 12673359 | 22 | Product used for unknown indication |
| 126733592 | 12673359 | 23 | Product used for unknown indication |
| 126733592 | 12673359 | 24 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126733592 | 12673359 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126733592 | 12673359 | Arterial thrombosis | |
| 126733592 | 12673359 | Cytomegalovirus infection | |
| 126733592 | 12673359 | Delayed graft function | |
| 126733592 | 12673359 | Graft loss | |
| 126733592 | 12673359 | Off label use | |
| 126733592 | 12673359 | Osteonecrosis | |
| 126733592 | 12673359 | Post procedural haematoma | |
| 126733592 | 12673359 | Renal transplant failure | |
| 126733592 | 12673359 | Transplant rejection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |