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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125304512 | 12530451 | 2 | F | 201107 | 20160824 | 20160706 | 20160831 | EXP | US-ASTELLAS-2016US025455 | ASTELLAS | RANABOTHU S, DEL RIO M. EARLY DIABETIC NEPHROPATHY IN A PEDIATRIC RENAL TRANSPLANT RECIPIENT LEADING TO END STAGE RENAL DISEASE. BLOOD-PURIF. 2016;41:234 | 17.69 | YR | F | Y | 0.00000 | 20160831 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125304512 | 12530451 | 1 | PS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | N | 50708 | FORMULATION UNKNOWN | ||||||||
| 125304512 | 12530451 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 3 | MG | FORMULATION UNKNOWN | Q12H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125304512 | 12530451 | 1 | Renal transplant |
| 125304512 | 12530451 | 2 | Renal transplant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125304512 | 12530451 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125304512 | 12530451 | Diabetes mellitus | |
| 125304512 | 12530451 | Diabetic nephropathy | |
| 125304512 | 12530451 | End stage renal disease | |
| 125304512 | 12530451 | Transplant rejection | |
| 125304512 | 12530451 | Treatment noncompliance |
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 |
|---|---|---|---|---|---|---|
| 125304512 | 12530451 | 1 | 20080610 | 201403 | 0 | |
| 125304512 | 12530451 | 2 | 201403 | 0 |