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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127108191 | 12710819 | 1 | I | 20160829 | 20160902 | 20160902 | EXP | US-ASTELLAS-2016US033488 | ASTELLAS | PULLALAREVU R, POSADAS SALAS A, MOUR G, SRINIVAS T, SALAZAR N, MOHAN P. RARE PRESENTATION OF PTLD AS PAROTITIS. AMERICAN JOURNAL OF TRANSPLANTATION. 2016;16(3):599 | 28.00 | YR | F | Y | 0.00000 | 20160902 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127108191 | 12710819 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 50708 | FORMULATION UNKNOWN | ||||||||
| 127108191 | 12710819 | 2 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127108191 | 12710819 | 3 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127108191 | 12710819 | 4 | C | BASILIXIMAB | BASILIXIMAB | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127108191 | 12710819 | 1 | Renal transplant |
| 127108191 | 12710819 | 2 | Renal transplant |
| 127108191 | 12710819 | 3 | Renal transplant |
| 127108191 | 12710819 | 4 | Immune tolerance induction |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127108191 | 12710819 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127108191 | 12710819 | Acute kidney injury | |
| 127108191 | 12710819 | Complications of transplanted kidney | |
| 127108191 | 12710819 | Epstein-Barr viraemia | |
| 127108191 | 12710819 | Glomerulonephropathy | |
| 127108191 | 12710819 | Graft haemorrhage | |
| 127108191 | 12710819 | Necrosis | |
| 127108191 | 12710819 | Otitis media | |
| 127108191 | 12710819 | Parotid gland enlargement | |
| 127108191 | 12710819 | Post transplant lymphoproliferative disorder | |
| 127108191 | 12710819 | Thrombotic microangiopathy | |
| 127108191 | 12710819 | Transplant rejection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |