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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127277621 | 12727762 | 1 | I | 20160901 | 20160909 | 20160909 | EXP | US-STRIDES ARCOLAB LIMITED-2016SP013095 | STRIDES | BOONYAPREDEE M, KNIGHT K, LITTLE D. INCREASED BK VIREMIA AND PROGRESSION TO BK-VIRUS NEPHROPATHY FOLLOWING HIGH-DOSE INTRAVENOUS IMMUNOGLOBULIN FOR ACUTE CELLULAR REJECTION. MIL-MED. 2014;179(6):E699-702 | 0.00 | Y | 0.00000 | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127277621 | 12727762 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 1000 MG, BID | 90055 | 1000 | MG | ||||||||
| 127277621 | 12727762 | 2 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 1000 MG/DAY | 90055 | 1000 | MG | ||||||||
| 127277621 | 12727762 | 3 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 500 MG/DAY | 90055 | 500 | MG | ||||||||
| 127277621 | 12727762 | 4 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | UNK | 90055 | |||||||||||
| 127277621 | 12727762 | 5 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 3 MG, BID | 0 | 3 | MG | ||||||||
| 127277621 | 12727762 | 6 | SS | TACROLIMUS. | TACROLIMUS | 1 | 6 MG/DAY | 0 | 6 | MG | |||||||||
| 127277621 | 12727762 | 7 | SS | TACROLIMUS. | TACROLIMUS | 1 | 4 MG/DAY | 0 | 4 | MG | |||||||||
| 127277621 | 12727762 | 8 | SS | TACROLIMUS. | TACROLIMUS | 1 | 2MG/DAY | 0 | 2 | MG | |||||||||
| 127277621 | 12727762 | 9 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | 10-DAY RECYCLE STARTING AT 60 MG/DAY | 0 | 60 | MG | |||||||||
| 127277621 | 12727762 | 10 | SS | IMMUNE GLOBULIN | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 2 G/KG | 0 | ||||||||||
| 127277621 | 12727762 | 11 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | 10 UNK, UNK | 0 | |||||||||||
| 127277621 | 12727762 | 12 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | 20 UNK, UNK | 0 | |||||||||||
| 127277621 | 12727762 | 13 | C | ALEMTUZUMAB | ALEMTUZUMAB | 1 | UNK | 0 | |||||||||||
| 127277621 | 12727762 | 14 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 500 MG (ON THE DAY OF TRANSPLANT) | 0 | 500 | MG | ||||||||
| 127277621 | 12727762 | 15 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 250 MG (ON POST-TRANSPLANT DAY ONE) | 0 | 250 | MG | ||||||||
| 127277621 | 12727762 | 16 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 125 MG (ON POST-TRANSPLANT DAY TWO) | 0 | 125 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127277621 | 12727762 | 1 | Immunosuppression |
| 127277621 | 12727762 | 5 | Immunosuppression |
| 127277621 | 12727762 | 9 | Transplant rejection |
| 127277621 | 12727762 | 10 | Polyomavirus-associated nephropathy |
| 127277621 | 12727762 | 11 | Polyomavirus-associated nephropathy |
| 127277621 | 12727762 | 13 | Immunosuppression |
| 127277621 | 12727762 | 14 | Immunosuppression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127277621 | 12727762 | HO |
| 127277621 | 12727762 | DE |
| 127277621 | 12727762 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127277621 | 12727762 | Acute kidney injury | |
| 127277621 | 12727762 | Acute respiratory failure | |
| 127277621 | 12727762 | BK virus infection | |
| 127277621 | 12727762 | Multiple organ dysfunction syndrome | |
| 127277621 | 12727762 | Pneumocystis jirovecii pneumonia | |
| 127277621 | 12727762 | Polyomavirus-associated nephropathy | |
| 127277621 | 12727762 | Septic shock | |
| 127277621 | 12727762 | Transplant rejection | |
| 127277621 | 12727762 | Tubulointerstitial nephritis |
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 |
|---|---|---|---|---|---|---|
| 127277621 | 12727762 | 2 | 20110301 | 201104 | 0 | |
| 127277621 | 12727762 | 3 | 20110501 | 201107 | 0 | |
| 127277621 | 12727762 | 6 | 20110301 | 0 | ||
| 127277621 | 12727762 | 7 | 20110401 | 201105 | 0 | |
| 127277621 | 12727762 | 8 | 20110601 | 201111 | 0 | |
| 127277621 | 12727762 | 11 | 20110801 | 0 | ||
| 127277621 | 12727762 | 12 | 20110901 | 201111 | 0 |