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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115752452 | 11575245 | 2 | F | 20060814 | 20160712 | 20150930 | 20160720 | EXP | JP-ASTELLAS-2007JP001997 | ASTELLAS | KENMOCHI T, ASANO T, SAIGO K, MARUYAMA M, AKUTSU N, IWASHITA C, ET AL.. ADAPTATION AND TREATMENT RESULTS OF LIVING DONOR PANCREAS TRANSPLANTATION FOR SEVERE TYPE I DIABETES MELLITUS. TRANSPLANTATION. 2008;43(S):250 | 32.00 | YR | F | Y | 47.00000 | KG | 20160720 | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115752452 | 11575245 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 0.15 MG/KG, ONCE DAILY | 50708 | .15 | MG/KG | CAPSULE | QD | ||||||
| 115752452 | 11575245 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 0.15 MG/KG, ONCE DAILY | U | 50708 | .15 | MG/KG | CAPSULE | QD | |||||
| 115752452 | 11575245 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Intravenous (not otherwise specified) | 0.05 MG/KG, ONCE DAILY | 0 | .05 | MG/KG | INJECTION | QD | ||||||
| 115752452 | 11575245 | 4 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | MODIFIED-RELEASE CAPSULE, HARD | ||||||||
| 115752452 | 11575245 | 5 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115752452 | 11575245 | 6 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | U | 0 | 1 | G | PER ORAL NOS | QD | ||||||
| 115752452 | 11575245 | 7 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | U | 0 | 1.5 | G | PER ORAL NOS | QD | ||||||
| 115752452 | 11575245 | 8 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | U | 0 | 10 | MG | PER ORAL NOS | QD | ||||||
| 115752452 | 11575245 | 9 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | U | 0 | 40 | MG | PER ORAL NOS | QD | ||||||
| 115752452 | 11575245 | 10 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | U | 0 | 30 | MG | PER ORAL NOS | QD | ||||||
| 115752452 | 11575245 | 11 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | U | 0 | 20 | MG | PER ORAL NOS | QD | ||||||
| 115752452 | 11575245 | 12 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | U | 0 | 10 | MG | PER ORAL NOS | QD | ||||||
| 115752452 | 11575245 | 13 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | U | 0 | 5 | MG | PER ORAL NOS | QD | ||||||
| 115752452 | 11575245 | 14 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | U | 0 | 50 | MG | INJECTION | QD | ||||||
| 115752452 | 11575245 | 15 | C | RITUXAN | RITUXIMAB | 1 | Intravenous drip | U | 0 | 200 | MG/M**2 | INJECTION | QD | ||||||
| 115752452 | 11575245 | 16 | C | METHYLPREDNISOLONE /00049603/ | 2 | Intravenous (not otherwise specified) | U | 0 | 500 | MG | INJECTION | QD | |||||||
| 115752452 | 11575245 | 17 | C | SIMULECT | BASILIXIMAB | 1 | Intravenous (not otherwise specified) | U | 0 | 20 | MG | INJECTION | QD | ||||||
| 115752452 | 11575245 | 18 | C | SIMULECT | BASILIXIMAB | 1 | Intravenous (not otherwise specified) | U | 0 | 20 | MG | INJECTION | QD | ||||||
| 115752452 | 11575245 | 19 | C | HEPARIN | HEPARIN SODIUM | 1 | Unknown | UNK UNK, CONTINUOUS | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115752452 | 11575245 | 20 | C | HEPARIN | HEPARIN SODIUM | 1 | Unknown | 5000-10000 UNITS, CONTINUOUSLY | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115752452 | 11575245 | 21 | C | BAYASPIRIN | ASPIRIN | 1 | Unknown | U | 0 | 100 | MG | FORMULATION UNKNOWN | QD | ||||||
| 115752452 | 11575245 | 22 | C | GABEXATE MESILATE | GABEXATE MESYLATE | 1 | Unknown | U | 0 | 600 | MG | FORMULATION UNKNOWN | |||||||
| 115752452 | 11575245 | 23 | C | GABEXATE MESILATE | GABEXATE MESYLATE | 1 | U | 0 | FORMULATION UNKNOWN | ||||||||||
| 115752452 | 11575245 | 24 | C | OCTREOTIDE. | OCTREOTIDE | 1 | Subcutaneous | U | 0 | 100 | UG | INJECTION | Q12H | ||||||
| 115752452 | 11575245 | 25 | C | OCTREOTIDE. | OCTREOTIDE | 1 | U | 0 | INJECTION | ||||||||||
| 115752452 | 11575245 | 26 | C | PIPERACILLIN | PIPERACILLIN | 1 | Intravenous (not otherwise specified) | UNK UNK, UNKNOWN FREQ. | U | 0 | INJECTION | ||||||||
| 115752452 | 11575245 | 27 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Intravenous (not otherwise specified) | UNK UNK, UNKNOWN FREQ. | U | 0 | INJECTION | ||||||||
| 115752452 | 11575245 | 28 | C | GANCICLOVIR. | GANCICLOVIR | 1 | Intravenous (not otherwise specified) | UNK UNK, UNKNOWN FREQ. | U | 0 | INJECTION | ||||||||
| 115752452 | 11575245 | 29 | C | GANCICLOVIR. | GANCICLOVIR | 1 | U | 0 | INJECTION | ||||||||||
| 115752452 | 11575245 | 30 | C | INSULIN ASPART | INSULIN ASPART | 1 | Intravenous (not otherwise specified) | U | 0 | 13 | IU | INJECTION | QD | ||||||
| 115752452 | 11575245 | 31 | C | INSULIN ASPART | INSULIN ASPART | 1 | Intravenous (not otherwise specified) | U | 0 | 9 | IU | INJECTION | QD | ||||||
| 115752452 | 11575245 | 32 | C | INSULIN ASPART | INSULIN ASPART | 1 | Intravenous (not otherwise specified) | U | 0 | 8 | IU | INJECTION | QD | ||||||
| 115752452 | 11575245 | 33 | C | INSULIN GLARGINE | INSULIN GLARGINE | 1 | Unknown | U | 0 | 10 | IU | INJECTION | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115752452 | 11575245 | 1 | Immunosuppressant drug therapy |
| 115752452 | 11575245 | 3 | Immunosuppressant drug therapy |
| 115752452 | 11575245 | 4 | Immunosuppressant drug therapy |
| 115752452 | 11575245 | 5 | Immunosuppressant drug therapy |
| 115752452 | 11575245 | 6 | Immunosuppressant drug therapy |
| 115752452 | 11575245 | 8 | Immunosuppressant drug therapy |
| 115752452 | 11575245 | 14 | Immunosuppressant drug therapy |
| 115752452 | 11575245 | 15 | Immunosuppressant drug therapy |
| 115752452 | 11575245 | 16 | Immunosuppressant drug therapy |
| 115752452 | 11575245 | 17 | Immunosuppressant drug therapy |
| 115752452 | 11575245 | 19 | Anticoagulant therapy |
| 115752452 | 11575245 | 21 | Anticoagulant therapy |
| 115752452 | 11575245 | 22 | Pancreatic leak |
| 115752452 | 11575245 | 23 | Prophylaxis |
| 115752452 | 11575245 | 24 | Pancreatic leak |
| 115752452 | 11575245 | 25 | Prophylaxis |
| 115752452 | 11575245 | 26 | Infection prophylaxis |
| 115752452 | 11575245 | 27 | Infection prophylaxis |
| 115752452 | 11575245 | 28 | Infection prophylaxis |
| 115752452 | 11575245 | 29 | Cytomegalovirus test positive |
| 115752452 | 11575245 | 30 | Type 1 diabetes mellitus |
| 115752452 | 11575245 | 33 | Type 1 diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115752452 | 11575245 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115752452 | 11575245 | Cytomegalovirus test positive | |
| 115752452 | 11575245 | Pancreatic leak | |
| 115752452 | 11575245 | Pancytopenia | |
| 115752452 | 11575245 | Renal impairment |
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 |
|---|---|---|---|---|---|---|
| 115752452 | 11575245 | 1 | 200606 | 0 | ||
| 115752452 | 11575245 | 2 | 20060712 | 0 | ||
| 115752452 | 11575245 | 3 | 20060705 | 20060711 | 0 | |
| 115752452 | 11575245 | 6 | 200606 | 0 | ||
| 115752452 | 11575245 | 7 | 20060706 | 0 | ||
| 115752452 | 11575245 | 8 | 2006 | 2006 | 0 | |
| 115752452 | 11575245 | 9 | 20060709 | 20060711 | 0 | |
| 115752452 | 11575245 | 10 | 20060712 | 20060714 | 0 | |
| 115752452 | 11575245 | 11 | 20060715 | 20060717 | 0 | |
| 115752452 | 11575245 | 12 | 20060717 | 20060731 | 0 | |
| 115752452 | 11575245 | 13 | 20060801 | 0 | ||
| 115752452 | 11575245 | 14 | 20060706 | 20060708 | 0 | |
| 115752452 | 11575245 | 15 | 20060621 | 20060621 | 0 | |
| 115752452 | 11575245 | 16 | 20060705 | 20060705 | 0 | |
| 115752452 | 11575245 | 17 | 20060705 | 20060705 | 0 | |
| 115752452 | 11575245 | 18 | 20060709 | 20060709 | 0 | |
| 115752452 | 11575245 | 19 | 20060705 | 20060705 | 0 | |
| 115752452 | 11575245 | 20 | 200607 | 200607 | 0 | |
| 115752452 | 11575245 | 21 | 200607 | 0 | ||
| 115752452 | 11575245 | 22 | 200607 | 200607 | 0 | |
| 115752452 | 11575245 | 24 | 200607 | 200607 | 0 | |
| 115752452 | 11575245 | 26 | 20060712 | 20060715 | 0 | |
| 115752452 | 11575245 | 27 | 20060712 | 20060715 | 0 | |
| 115752452 | 11575245 | 28 | 20060712 | 20060715 | 0 | |
| 115752452 | 11575245 | 30 | 200607 | 0 | ||
| 115752452 | 11575245 | 33 | 20060805 | 0 |