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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125036162 | 12503616 | 2 | F | 20151106 | 20160721 | 20160628 | 20160727 | EXP | JP-ASTELLAS-2016JP010037 | ASTELLAS | 57.36 | YR | M | Y | 0.00000 | 20160727 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125036162 | 12503616 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 261 | MG | 204096 | 1 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 125036162 | 12503616 | 2 | SS | NEORAL | CYCLOSPORINE | 1 | Unknown | 0 | 50 | MG | FORMULATION UNKNOWN | QD | |||||||
| 125036162 | 12503616 | 3 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Oral | U | 0 | 4 | MG | PER ORAL NOS | QD | ||||||
| 125036162 | 12503616 | 4 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Oral | U | 0 | 50 | MG | PER ORAL NOS | QD | ||||||
| 125036162 | 12503616 | 5 | C | DIOVAN | VALSARTAN | 1 | Unknown | U | 0 | 80 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125036162 | 12503616 | 6 | C | URINORM | BENZBROMARONE | 1 | Unknown | UNK UNK, ONCE DAILY | U | 0 | 50 | MG | FORMULATION UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125036162 | 12503616 | 1 | Prophylaxis against transplant rejection |
| 125036162 | 12503616 | 2 | Prophylaxis against transplant rejection |
| 125036162 | 12503616 | 3 | Prophylaxis against transplant rejection |
| 125036162 | 12503616 | 4 | Prophylaxis against transplant rejection |
| 125036162 | 12503616 | 5 | Hypertension |
| 125036162 | 12503616 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125036162 | 12503616 | HO |
| 125036162 | 12503616 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125036162 | 12503616 | Transplant rejection |
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 |
|---|---|---|---|---|---|---|
| 125036162 | 12503616 | 1 | 20150219 | 20151125 | 0 | |
| 125036162 | 12503616 | 2 | 20150218 | 0 | ||
| 125036162 | 12503616 | 3 | 2015 | 0 |