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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126335031 | 12633503 | 1 | I | 20160729 | 20160802 | 20160808 | 20160808 | EXP | PHHY2016BR107891 | NOVARTIS | 47.00 | YR | M | Y | 0.00000 | 20160808 | MD | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126335031 | 12633503 | 1 | PS | EVEROLIMUS | EVEROLIMUS | 1 | Unknown | UNK | 21560 | ||||||||||
| 126335031 | 12633503 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | U | 0 | ||||||||||
| 126335031 | 12633503 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 6 NG/ML, UNK | U | 0 | |||||||||
| 126335031 | 12633503 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | ||||||||||
| 126335031 | 12633503 | 5 | SS | THYMOGLOBULIN | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Unknown | 3 MG/KG, ONCE/SINGLE | 0 | 3 | MG/KG | 1X |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126335031 | 12633503 | 1 | Renal transplant |
| 126335031 | 12633503 | 2 | Renal transplant |
| 126335031 | 12633503 | 4 | Renal transplant |
| 126335031 | 12633503 | 5 | Renal transplant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126335031 | 12633503 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126335031 | 12633503 | Drug-induced liver injury | |
| 126335031 | 12633503 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 126335031 | 12633503 | 3 | 20160801 | 0 |