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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 85402287 | 8540228 | 7 | F | 201004 | 20160914 | 20120502 | 20160920 | EXP | JP-ASTELLAS-2011JP005424 | ASTELLAS | YOSHIZAWA A, YASUI Y, OGAWA E, OKAMOTO S, OKAJIMA H, UEMOTO S. A CASE OF HEPATIC DISORDER AND RENAL DISORDER AFTER LIVER/SMALL INTESTINE HETEROCHRONIC TRANSPLANTATION. JAPANESE JOURNAL OF TRANSPLANTATION (E-JOURNAL). 2015;50(4-5):449 | 18.00 | YR | M | Y | 28.00000 | KG | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 85402287 | 8540228 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Intravenous drip | 0.045 MG/KG, ONCE DAILY | U | 50709 | .045 | MG/KG | INJECTION | QD | |||||
| 85402287 | 8540228 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Intravenous drip | 0.023 MG/KG, ONCE DAILY | U | 50709 | .023 | MG/KG | INJECTION | QD | |||||
| 85402287 | 8540228 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | CAPSULES+GRANULES 0.06MG/KG | U | 0 | CAPSULE | ||||||||
| 85402287 | 8540228 | 4 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | CAPSULES+GRANULES 0.11MG/KG | U | 0 | CAPSULE | ||||||||
| 85402287 | 8540228 | 5 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | CAPSULES+GRANULES 0.06MG/KG | U | 0 | GRANULES | ||||||||
| 85402287 | 8540228 | 6 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | CAPSULES+GRANULES 0.11MG/KG | U | 0 | GRANULES | ||||||||
| 85402287 | 8540228 | 7 | C | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 85402287 | 8540228 | 8 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | D | U | 0 | 10 | MG/KG | FORMULATION UNKNOWN | QD | |||||
| 85402287 | 8540228 | 9 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 85402287 | 8540228 | 10 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 10-20MG/KG/DAY, TAPERED | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 85402287 | 8540228 | 11 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 1.25?4, 1?4, 0.75?4, AND AFTER 6H AND 12H FOR EACH, 0.5?4MG/KG | D | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 85402287 | 8540228 | 1 | Prophylaxis against transplant rejection |
| 85402287 | 8540228 | 2 | Immunosuppressant drug therapy |
| 85402287 | 8540228 | 3 | Prophylaxis against transplant rejection |
| 85402287 | 8540228 | 4 | Immunosuppressant drug therapy |
| 85402287 | 8540228 | 5 | Prophylaxis against transplant rejection |
| 85402287 | 8540228 | 6 | Immunosuppressant drug therapy |
| 85402287 | 8540228 | 7 | Immunosuppressant drug therapy |
| 85402287 | 8540228 | 8 | Prophylaxis against transplant rejection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 85402287 | 8540228 | OT |
| 85402287 | 8540228 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 85402287 | 8540228 | Bronchopulmonary aspergillosis | |
| 85402287 | 8540228 | Cytomegalovirus enterocolitis | |
| 85402287 | 8540228 | Drug ineffective | |
| 85402287 | 8540228 | Hepatic failure | |
| 85402287 | 8540228 | Peritonitis bacterial | |
| 85402287 | 8540228 | Renal impairment | |
| 85402287 | 8540228 | Transplant rejection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |