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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126421282 | 12642128 | 2 | F | 20160804 | 20160810 | 20160811 | EXP | PHHY2016PL108137 | SANDOZ | DEBORSKA-MATERKOWSKA D, SERWANSKA-SWIETEK M, WSZOTA M, KWIATKOWSKI A, DURLIKA M, PERKOWSKA-PTASINSKA A. NEPHROPATHY EVOLVING WITHIN THE FIRST TWO POSTTRANSPLANT MONTHS WITH NO TYPICAL CYTOPATHIC LESIONS: TWO CASES PRESENTATION. TRANSPLANTATION PROCEEDINGS. 2016;48:1611-15 | 70.00 | YR | M | Y | 0.00000 | 20160811 | OT | PL | PL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126421282 | 12642128 | 1 | SS | BASILIXIMAB | BASILIXIMAB | 1 | Unknown | U | 0 | ||||||||||
| 126421282 | 12642128 | 2 | SS | BASILIXIMAB | BASILIXIMAB | 1 | U | 0 | |||||||||||
| 126421282 | 12642128 | 3 | PS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | Y | 65461 | ||||||||||
| 126421282 | 12642128 | 4 | SS | TACROLIMUS. | TACROLIMUS | 1 | Y | 65461 | |||||||||||
| 126421282 | 12642128 | 5 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 2000 MG, UNK | 0 | 2000 | MG | ||||||||
| 126421282 | 12642128 | 6 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126421282 | 12642128 | 1 | Renal transplant |
| 126421282 | 12642128 | 2 | Immunosuppressant drug therapy |
| 126421282 | 12642128 | 3 | Renal transplant |
| 126421282 | 12642128 | 4 | Immunosuppressant drug therapy |
| 126421282 | 12642128 | 5 | Renal transplant |
| 126421282 | 12642128 | 6 | Immunosuppressant drug therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126421282 | 12642128 | HO |
| 126421282 | 12642128 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126421282 | 12642128 | Arteriosclerosis | |
| 126421282 | 12642128 | BK virus infection | |
| 126421282 | 12642128 | Basal cell carcinoma | |
| 126421282 | 12642128 | Delayed graft function | |
| 126421282 | 12642128 | Glomerular filtration rate decreased | |
| 126421282 | 12642128 | Kidney transplant rejection | |
| 126421282 | 12642128 | Pneumonia bacterial | |
| 126421282 | 12642128 | Polyomavirus-associated nephropathy | |
| 126421282 | 12642128 | Renal tubular necrosis | |
| 126421282 | 12642128 | Tubulointerstitial nephritis | |
| 126421282 | 12642128 | Viraemia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |