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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123251044 | 12325104 | 4 | F | 20130417 | 20160818 | 20160502 | 20160825 | EXP | PHJP2016JP010162 | SANDOZ | HAYASHI Y, AKIKAWA E, YAMAGUCHI M, FUJII S, TSUKAMOTO Y, OSAKA M ET AL.. A CASE OF INCREASED CYA BLOOD LEVEL DUE TO COMBINATION USE OF CYA AND TOLVAPTAN. THE 49TH ANNUAL MEETING OF JAPANESE SPCIETY FOR CLINICAL RENAL TRANSPLANTATION. 324 | 68.25 | YR | M | Y | 54.00000 | KG | 20160825 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123251044 | 12325104 | 1 | PS | NEORAL | CYCLOSPORINE | 1 | Oral | 125 MG, QD (75 MG AND 50 MG) | Y | 0 | 125 | MG | QD | ||||||
| 123251044 | 12325104 | 2 | I | NEORAL | CYCLOSPORINE | 1 | Oral | 75 MG, UNK | Y | 0 | 75 | MG | |||||||
| 123251044 | 12325104 | 3 | I | SAMSCA | TOLVAPTAN | 1 | Unknown | 7.5 MG, QD | Y | 0 | 7.5 | MG | QD | ||||||
| 123251044 | 12325104 | 4 | I | SAMSCA | TOLVAPTAN | 1 | Unknown | 7.5 MG, QD | Y | 0 | 7.5 | MG | QD | ||||||
| 123251044 | 12325104 | 5 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | 5 MG, QD | U | 0 | 5 | MG | QD | ||||||
| 123251044 | 12325104 | 6 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | U | 0 | |||||||||||
| 123251044 | 12325104 | 7 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | 250 MG, TID | U | 0 | 250 | MG | TID | ||||||
| 123251044 | 12325104 | 8 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 123251044 | 12325104 | 9 | C | ATORVASTATIN | ATORVASTATIN | 1 | Unknown | 5 MG, QD | U | 0 | 5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123251044 | 12325104 | 1 | Renal transplant |
| 123251044 | 12325104 | 2 | Immunosuppressant drug therapy |
| 123251044 | 12325104 | 3 | Cardiac failure |
| 123251044 | 12325104 | 4 | Fluid overload |
| 123251044 | 12325104 | 5 | Renal transplant |
| 123251044 | 12325104 | 6 | Immunosuppressant drug therapy |
| 123251044 | 12325104 | 7 | Renal transplant |
| 123251044 | 12325104 | 8 | Immunosuppressant drug therapy |
| 123251044 | 12325104 | 9 | Dyslipidaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123251044 | 12325104 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123251044 | 12325104 | Blood sodium increased | |
| 123251044 | 12325104 | Drug interaction | |
| 123251044 | 12325104 | Fluid overload | |
| 123251044 | 12325104 | Immunosuppressant drug level increased | |
| 123251044 | 12325104 | Renal impairment |
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 |
|---|---|---|---|---|---|---|
| 123251044 | 12325104 | 1 | 2003 | 0 | ||
| 123251044 | 12325104 | 2 | 2016 | 0 | ||
| 123251044 | 12325104 | 3 | 20130511 | 20130520 | 0 | |
| 123251044 | 12325104 | 4 | 20131115 | 20131120 | 0 |