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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125803021 | 12580302 | 1 | I | 20160714 | 20160721 | 20160721 | EXP | RO-ASTELLAS-2016US027879 | ASTELLAS | 43.00 | YR | M | Y | 0.00000 | 20160721 | OT | CH | RO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125803021 | 12580302 | 1 | PS | Tacrolimus Systemic | TACROLIMUS | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 50708 | FORMULATION UNKNOWN | ||||||||
| 125803021 | 12580302 | 2 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 125803021 | 12580302 | 3 | SS | BASILIXIMAB | BASILIXIMAB | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125803021 | 12580302 | 1 | Renal and pancreas transplant |
| 125803021 | 12580302 | 2 | Renal and pancreas transplant |
| 125803021 | 12580302 | 3 | Renal and pancreas transplant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125803021 | 12580302 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125803021 | 12580302 | Arteritis infective | |
| 125803021 | 12580302 | Candida infection | |
| 125803021 | 12580302 | Iliac artery rupture | |
| 125803021 | 12580302 | Large intestine perforation | |
| 125803021 | 12580302 | Off label use | |
| 125803021 | 12580302 | Pancreatitis acute | |
| 125803021 | 12580302 | Peritonitis | |
| 125803021 | 12580302 | Splenic artery thrombosis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |