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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126733661 | 12673366 | 1 | I | 20160517 | 20160822 | 20160822 | EXP | TH-ASTELLAS-2016JP007837 | ASTELLAS | 62.00 | YR | F | Y | 0.00000 | 20160822 | OT | GB | TH |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126733661 | 12673366 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | Y | 50708 | 1.5 | MG | FORMULATION UNKNOWN | BID | ||||||
| 126733661 | 12673366 | 2 | SS | BASILIXIMAB | BASILIXIMAB | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | Y | 0 | FORMULATION UNKNOWN | ||||||||
| 126733661 | 12673366 | 3 | SS | MYCOPHENOLIC ACID. | MYCOPHENOLIC ACID | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | Y | 0 | FORMULATION UNKNOWN | ||||||||
| 126733661 | 12673366 | 4 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | Y | 0 | FORMULATION UNKNOWN | ||||||||
| 126733661 | 12673366 | 5 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126733661 | 12673366 | 6 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | U | 0 | 2000 | MG | INJECTION | |||||||
| 126733661 | 12673366 | 7 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | U | 0 | 2000 | MG | INJECTION | |||||||
| 126733661 | 12673366 | 8 | C | IMMUNOGLOBULIN /00025201/ | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | U | 0 | 115 | G | FORMULATION UNKNOWN | |||||||
| 126733661 | 12673366 | 9 | C | IMMUNOGLOBULIN /00025201/ | HUMAN IMMUNOGLOBULIN G | 1 | U | 0 | FORMULATION UNKNOWN | ||||||||||
| 126733661 | 12673366 | 10 | C | GANCICLOVIR. | GANCICLOVIR | 1 | Intravenous (not otherwise specified) | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126733661 | 12673366 | 1 | Immunosuppressant drug therapy |
| 126733661 | 12673366 | 2 | Immunosuppressant drug therapy |
| 126733661 | 12673366 | 3 | Immunosuppressant drug therapy |
| 126733661 | 12673366 | 4 | Immunosuppressant drug therapy |
| 126733661 | 12673366 | 6 | Transplant rejection |
| 126733661 | 12673366 | 7 | Transplant rejection |
| 126733661 | 12673366 | 8 | Transplant rejection |
| 126733661 | 12673366 | 9 | Transplant rejection |
| 126733661 | 12673366 | 10 | Cytomegalovirus infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126733661 | 12673366 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126733661 | 12673366 | Cytomegalovirus infection | |
| 126733661 | 12673366 | Hydronephrosis | |
| 126733661 | 12673366 | Pancytopenia | |
| 126733661 | 12673366 | Polyomavirus-associated nephropathy | |
| 126733661 | 12673366 | Transaminases increased | |
| 126733661 | 12673366 | Transplant rejection | |
| 126733661 | 12673366 | Ureteric obstruction |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |