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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125013043 | 12501304 | 3 | F | 20160914 | 20160627 | 20160926 | EXP | JP-CONCORDIA PHARMACEUTICALS INC.-E2B_00007778 | CONCORDIA | MUTO T,TAKEDA Y,TSUKAMOTO S,SAKAI S,MIMURA N,OHWADA C. SUCCESSFUL TREATMENT OF CYTOMEGALOVIRUS ENTERITIS AFTER UNRELATED ALLOGENEIC STEM CELL TRANSPLANTATION BY THE INFUSION OF EX VIVO-EXPANDED CD4+ LYMPHOCYTES DERIVED FROM THE RECIPIENT^S PERIPHERAL BLOOD DONOR CELLS.. TRANSPLANT INFECTIOUS DISEASE 2016;18(1):93-97. | 48.00 | YR | M | Y | 0.00000 | 20160926 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125013043 | 12501304 | 1 | PS | PREDNISOLONE. | PREDNISOLONE | 1 | U | 21959 | 2 | MG/KG | |||||||||
| 125013043 | 12501304 | 2 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | Y | 0 | |||||||||||
| 125013043 | 12501304 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | SHORT-COURSE | U | 0 | ||||||||||
| 125013043 | 12501304 | 4 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | 500 MG/BODY | U | 0 | 500 | MG | ||||||||
| 125013043 | 12501304 | 5 | SS | TACROLIMUS. | TACROLIMUS | 1 | U | 0 | |||||||||||
| 125013043 | 12501304 | 6 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | U | 0 | 120 | MG/KG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125013043 | 12501304 | 1 | Engraftment syndrome |
| 125013043 | 12501304 | 2 | Prophylaxis against graft versus host disease |
| 125013043 | 12501304 | 3 | Prophylaxis against graft versus host disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125013043 | 12501304 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125013043 | 12501304 | Cytomegalovirus enteritis | |
| 125013043 | 12501304 | Rash |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |