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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124255633 | 12425563 | 3 | F | 201506 | 20160805 | 20160601 | 20160810 | EXP | PHJP2016JP014319 | NOVARTIS | KONO H, SAKAMAKI Y, MORITA S, SHINODA K, OJIMA K, OGIWARA K ET AL.. A CASE OF POSSIBLE PRIMARY BILIARY CIRRHOSIS AFTER LIVING RENAL TRANSPLANTATION. THE 32ND JAPANESE SOCIETY OF RENAL TRANSPLANTATION AND VASCULAR SURGERY. 94 | 0.00 | A | F | Y | 0.00000 | 20160811 | OT | JP | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124255633 | 12425563 | 1 | PS | CERTICAN | EVEROLIMUS | 1 | Oral | UNK | 21560 | TABLET | |||||||||
| 124255633 | 12425563 | 2 | SS | CERTICAN | EVEROLIMUS | 1 | 21560 | TABLET | |||||||||||
| 124255633 | 12425563 | 3 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | UNK | 0 | CAPSULE | |||||||||
| 124255633 | 12425563 | 4 | SS | NEORAL | CYCLOSPORINE | 1 | 0 | CAPSULE | |||||||||||
| 124255633 | 12425563 | 5 | SS | NEORAL | CYCLOSPORINE | 1 | 0 | CAPSULE | |||||||||||
| 124255633 | 12425563 | 6 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 124255633 | 12425563 | 7 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 124255633 | 12425563 | 8 | C | MERCAPTOPURINE. | MERCAPTOPURINE | 1 | Unknown | UNK | Y | 0 | |||||||||
| 124255633 | 12425563 | 9 | C | MERCAPTOPURINE. | MERCAPTOPURINE | 1 | Y | 0 | |||||||||||
| 124255633 | 12425563 | 10 | C | MERCAPTOPURINE. | MERCAPTOPURINE | 1 | Y | 0 | |||||||||||
| 124255633 | 12425563 | 11 | C | BASILIXIMAB | BASILIXIMAB | 1 | Unknown | UNK | U | 0 | |||||||||
| 124255633 | 12425563 | 12 | C | BASILIXIMAB | BASILIXIMAB | 1 | U | 0 | |||||||||||
| 124255633 | 12425563 | 13 | C | BASILIXIMAB | BASILIXIMAB | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124255633 | 12425563 | 1 | Renal transplant |
| 124255633 | 12425563 | 2 | Prophylaxis against transplant rejection |
| 124255633 | 12425563 | 3 | Renal transplant |
| 124255633 | 12425563 | 4 | Prophylaxis against transplant rejection |
| 124255633 | 12425563 | 5 | Immunosuppressant drug therapy |
| 124255633 | 12425563 | 6 | Renal transplant |
| 124255633 | 12425563 | 7 | Immunosuppressant drug therapy |
| 124255633 | 12425563 | 8 | Renal transplant |
| 124255633 | 12425563 | 9 | Immunosuppressant drug therapy |
| 124255633 | 12425563 | 10 | Prophylaxis against transplant rejection |
| 124255633 | 12425563 | 11 | Renal transplant |
| 124255633 | 12425563 | 12 | Immunosuppressant drug therapy |
| 124255633 | 12425563 | 13 | Prophylaxis against transplant rejection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124255633 | 12425563 | HO |
| 124255633 | 12425563 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124255633 | 12425563 | Antimitochondrial antibody positive | |
| 124255633 | 12425563 | Autoimmune disorder | |
| 124255633 | 12425563 | Biliary cirrhosis primary | |
| 124255633 | 12425563 | Biliary dilatation | |
| 124255633 | 12425563 | Blood alkaline phosphatase increased | |
| 124255633 | 12425563 | Gallbladder enlargement | |
| 124255633 | 12425563 | Gamma-glutamyltransferase increased | |
| 124255633 | 12425563 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 124255633 | 12425563 | 1 | 201307 | 0 | ||
| 124255633 | 12425563 | 8 | 201307 | 0 |