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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126787951 | 12678795 | 1 | I | 20160815 | 20160824 | 20160824 | EXP | ES-ROCHE-1815339 | ROCHE | , DIEKMANN F, REVUELTA I, ESFORZADO N, RICART M, COFAN F, TORREGROSA J, PERI L, RUIZ A, CAMPISTO J AND OPPENHEIMER F. AN MTOR-INHIBITOR-BASED PROTOCOL AND CALCINEURIN INHIBITOR (CNI)-FREE TREATMENT IN KIDNEY TRANSPLANT RECIPIENTS FROM DONORS AFTER CARDIAC DEATH: GOOD RENAL FUNCTION, BUT HIGH INCIDENCE OF CONVERSION TO CNI.. TRANSPLANT INTERNATIONAL 2016;29 (3):362-368. | 0.00 | Y | 0.00000 | 20160824 | OT | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126787951 | 12678795 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 2000 MG AS LOADING DOSE | U | 50722 | |||||||||
| 126787951 | 12678795 | 2 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | U | 50722 | 1000 | MG | BID | |||||||
| 126787951 | 12678795 | 3 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | POST OPERATIVE AFTER 3 MONTHS, MAINTENANCE DOSE OF 1000- 2000 MG/DAY | U | 50722 | |||||||||
| 126787951 | 12678795 | 4 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | U | 0 | .1 | MG/KG | Q12H | |||||||
| 126787951 | 12678795 | 5 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | TO ACHIEVE TROUGH LEVEL 5-10 NG/ML | U | 0 | |||||||||
| 126787951 | 12678795 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | DOSE OF 500 MG, 125 MG, AND 0.5 MG/KG ON THE DAY OF SURGERY, POSTOPERATIVE DAY 1, AND POSTOPERATIVE | U | 0 | |||||||||
| 126787951 | 12678795 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | ||||||||||
| 126787951 | 12678795 | 8 | SS | RAPAMYCIN | SIROLIMUS | 1 | Unknown | ON POSTOPERATIVE DAYS 6, 7, AND 8, A DOSE OF 6 MG/KG DEMONSTRATION FOLLOWED BY 3 MG ON POSTOPERATIVE | U | 0 | |||||||||
| 126787951 | 12678795 | 9 | SS | EVEROLIMUS | EVEROLIMUS | 1 | Unknown | ON POSTOPERATIVE DAYS 6, 7, AND 8, A DOSE OF 6 MG/KG DEMONSTRATION FOLLOWED BY 3 MG ON POSTOPERATIVE | U | 0 | |||||||||
| 126787951 | 12678795 | 10 | SS | ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT) | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Unknown | U | 0 | ||||||||||
| 126787951 | 12678795 | 11 | SS | MYCOPHENOLATE SODIUM | MYCOPHENOLATE SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 126787951 | 12678795 | 12 | SS | MYCOPHENOLATE SODIUM | MYCOPHENOLATE SODIUM | 1 | Unknown | THREE MONTHS AFTER TRANSPLANTATION, MAINTENANCE DOSE OF 1080-1440 MG/DAY | U | 0 | |||||||||
| 126787951 | 12678795 | 13 | C | SULFAMETHOXAZOLE/TRIMETHOPRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 400/80 MG/DAY WAS ADMINISTERED 6 MONTHS POSTOPERATIVELY. | 0 | ||||||||||
| 126787951 | 12678795 | 14 | C | VALGANCICLOVIR. | VALGANCICLOVIR | 1 | Unknown | FOR 3 MONTHS POSTOPERATIVELY | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126787951 | 12678795 | 1 | Prophylaxis against transplant rejection |
| 126787951 | 12678795 | 4 | Prophylaxis against transplant rejection |
| 126787951 | 12678795 | 6 | Prophylaxis against transplant rejection |
| 126787951 | 12678795 | 8 | Prophylaxis against transplant rejection |
| 126787951 | 12678795 | 9 | Prophylaxis against transplant rejection |
| 126787951 | 12678795 | 10 | Prophylaxis against transplant rejection |
| 126787951 | 12678795 | 11 | Prophylaxis against transplant rejection |
| 126787951 | 12678795 | 13 | Antifungal prophylaxis |
| 126787951 | 12678795 | 14 | Antiviral prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126787951 | 12678795 | DE |
| 126787951 | 12678795 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126787951 | 12678795 | Anaemia | |
| 126787951 | 12678795 | Cytomegalovirus infection | |
| 126787951 | 12678795 | Diarrhoea | |
| 126787951 | 12678795 | Dyslipidaemia | |
| 126787951 | 12678795 | Fistula | |
| 126787951 | 12678795 | Graft loss | |
| 126787951 | 12678795 | Hernia | |
| 126787951 | 12678795 | Impaired healing | |
| 126787951 | 12678795 | Infection | |
| 126787951 | 12678795 | Leukopenia | |
| 126787951 | 12678795 | Lymphocele | |
| 126787951 | 12678795 | Lymphorrhoea | |
| 126787951 | 12678795 | Neoplasm | |
| 126787951 | 12678795 | Oedema | |
| 126787951 | 12678795 | Pneumonitis | |
| 126787951 | 12678795 | Proteinuria | |
| 126787951 | 12678795 | Transplant rejection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |