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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1138005112 | 11380051 | 12 | F | 201507 | 20160804 | 20150814 | 20160808 | EXP | PHHY2015CN090317 | NOVARTIS | 28.34 | YR | M | Y | 53.00000 | KG | 20160808 | MD | CN | CN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1138005112 | 11380051 | 1 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Oral | 360 MG, BID | 15753.4424 | MG | U | 0 | 360 | MG | BID | ||||
| 1138005112 | 11380051 | 2 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Oral | 1080 MG, QD | 15753.4424 | MG | U | 0 | 1080 | MG | QD | ||||
| 1138005112 | 11380051 | 3 | PS | NEORAL | CYCLOSPORINE | 1 | Oral | 150 MG, QD | U | 50715 | 150 | MG | QD | ||||||
| 1138005112 | 11380051 | 4 | C | CICLOSPORINE | CYCLOSPORINE | 1 | Unknown | 300 MG, QD | 0 | 300 | MG | SOFT GELATIN CAPSULE | QD | ||||||
| 1138005112 | 11380051 | 5 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 16 MG, QD | 0 | 16 | MG | TABLET | QD | ||||||
| 1138005112 | 11380051 | 6 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | 0 | TABLET | |||||||||||
| 1138005112 | 11380051 | 7 | C | CALCITRIOL. | CALCITRIOL | 1 | Unknown | 1 UG, QD | 0 | 1 | UG | SOFT GELATIN CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1138005112 | 11380051 | 1 | Renal transplant |
| 1138005112 | 11380051 | 2 | Prophylaxis against transplant rejection |
| 1138005112 | 11380051 | 3 | Renal transplant |
| 1138005112 | 11380051 | 4 | Immunosuppressant drug therapy |
| 1138005112 | 11380051 | 5 | Kidney transplant rejection |
| 1138005112 | 11380051 | 6 | Immunosuppressant drug therapy |
| 1138005112 | 11380051 | 7 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1138005112 | 11380051 | OT |
| 1138005112 | 11380051 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1138005112 | 11380051 | Epididymitis | |
| 1138005112 | 11380051 | Extravasation of urine | |
| 1138005112 | 11380051 | Kidney transplant rejection | |
| 1138005112 | 11380051 | Lung infection | |
| 1138005112 | 11380051 | Pyrexia | |
| 1138005112 | 11380051 | Scrotal pain | |
| 1138005112 | 11380051 | Urinary fistula | |
| 1138005112 | 11380051 | Urinary tract infection | |
| 1138005112 | 11380051 | Urinary tract infection enterococcal | |
| 1138005112 | 11380051 | Urine output decreased |
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 |
|---|---|---|---|---|---|---|
| 1138005112 | 11380051 | 1 | 20150712 | 20160110 | 0 | |
| 1138005112 | 11380051 | 2 | 20160111 | 0 | ||
| 1138005112 | 11380051 | 3 | 20151022 | 0 | ||
| 1138005112 | 11380051 | 4 | 20150721 | 0 | ||
| 1138005112 | 11380051 | 5 | 20150721 | 0 | ||
| 1138005112 | 11380051 | 7 | 20150721 | 0 |