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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103477254 | 10347725 | 4 | F | 20110628 | 20160826 | 20140729 | 20160902 | EXP | CA-ASTELLAS-2011US005105 | ASTELLAS | 37.02 | YR | M | Y | 0.00000 | 20160902 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103477254 | 10347725 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 25 | MG | 204096 | 5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 103477254 | 10347725 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 25 | MG | U | 204096 | 10 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 103477254 | 10347725 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 25 | MG | 204096 | 15 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 103477254 | 10347725 | 4 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 103477254 | 10347725 | 1 | Renal transplant |
| 103477254 | 10347725 | 4 | Renal transplant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 103477254 | 10347725 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 103477254 | 10347725 | Kidney transplant rejection | |
| 103477254 | 10347725 | Superinfection | |
| 103477254 | 10347725 | Urinary anastomotic leak | |
| 103477254 | 10347725 | Urosepsis |
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 |
|---|---|---|---|---|---|---|
| 103477254 | 10347725 | 1 | 20110701 | 20110707 | 0 | |
| 103477254 | 10347725 | 2 | 20110708 | 20110709 | 0 | |
| 103477254 | 10347725 | 3 | 20110710 | 20110718 | 0 | |
| 103477254 | 10347725 | 4 | 20110617 | 0 |