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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126827341 | 12682734 | 1 | I | 20160822 | 20160825 | 20160825 | EXP | JP-ROCHE-1817642 | ROCHE | TAKAHASHI K, SAITO K, TAKAHARA S, FUCHINOUE S, YAGISAWA T, AIKAWA A, WATARAI Y, YOSHIMURA N, TANABE K, MOROZUMI K AND SHIMAZU M. RESULTS OF A MULTICENTER PROSPECTIVE CLINICAL STUDY IN JAPAN FOR EVALUATING EFFICACY AND SAFETY OF DESENSITIZATION PROTOCOL BASED ON RITUXIMAB IN ABO-INCOMPATIBLE KIDNEY TRANSPLANTATION. CLINICAL AND EXPERIMENTAL NEPHROLOGY 2016 AUG 17;:-. | 0.00 | Y | 0.00000 | 20160825 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126827341 | 12682734 | 1 | PS | Rituximab | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 14 DAYS AND 1 DAY PRETRANSPLANT | 103705 | 375 | MG/M**2 | SOLUTION FOR INFUSION | |||||||
| 126827341 | 12682734 | 2 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 28 DAYS BEFORE TRANSPLANTATION | 50722 | ||||||||||
| 126827341 | 12682734 | 3 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 28 DAYS BEFORE TRANSPLANTATION | 0 | ||||||||||
| 126827341 | 12682734 | 4 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0.15-0.20 MG/KG/DAY, STARTED 2 DAYS PRETRANSPLANT | U | 0 | |||||||||
| 126827341 | 12682734 | 5 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | Unknown | 6-8 MG/KG/DAY, STARTED 1 DAY PRETRANSPLANT | U | 0 | |||||||||
| 126827341 | 12682734 | 6 | SS | BASILIXIMAB | BASILIXIMAB | 1 | Unknown | 20 MG/BODY ON THE DAY OF TRANSPLANTATION 4 DAYS POSTTRANSPLANT | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126827341 | 12682734 | 1 | Prophylaxis against transplant rejection |
| 126827341 | 12682734 | 2 | Prophylaxis against transplant rejection |
| 126827341 | 12682734 | 3 | Prophylaxis against transplant rejection |
| 126827341 | 12682734 | 4 | Prophylaxis against transplant rejection |
| 126827341 | 12682734 | 5 | Prophylaxis against transplant rejection |
| 126827341 | 12682734 | 6 | Prophylaxis against transplant rejection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126827341 | 12682734 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126827341 | 12682734 | Blood pressure increased | |
| 126827341 | 12682734 | Cytomegalovirus infection | |
| 126827341 | 12682734 | Duodenal ulcer | |
| 126827341 | 12682734 | Hand-foot-and-mouth disease | |
| 126827341 | 12682734 | Herpes zoster | |
| 126827341 | 12682734 | Neutrophil count decreased | |
| 126827341 | 12682734 | Pyrexia | |
| 126827341 | 12682734 | Upper respiratory tract inflammation | |
| 126827341 | 12682734 | Urinary tract infection | |
| 126827341 | 12682734 | White blood cell count decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |