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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126280391 | 12628039 | 1 | I | 20160802 | 20160807 | 20160807 | EXP | PHHY2016CN107029 | NOVARTIS | LOU S, LUO Y, ZENG H, SHEN Y, ZHANG P, CHEN L ET AL.. ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION FOLLOWING DONOR CIK CELL INFUSION: A PHASE I STUDY IN PATIENTS WITH RELAPSED/REFRACTORY HEMATOLOGIC MALIGNANCIES. LEUKEMIA RESEARCH. 2016;48:6-10 | 24.00 | YR | M | Y | 0.00000 | 20160808 | OT | CN | CN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126280391 | 12628039 | 1 | PS | NEORAL | CYCLOSPORINE | 1 | Intravenous (not otherwise specified) | 2.5 MG/KG, QD | U | 50715 | 2.5 | MG/KG | QD | ||||||
| 126280391 | 12628039 | 2 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 5 MG/KG, UNK (FOR 3-6 MONTHS) | U | 50715 | 5 | MG/KG | |||||||
| 126280391 | 12628039 | 3 | SS | SIMULECT | BASILIXIMAB | 1 | Intravenous (not otherwise specified) | 20 MG, ON THE DAY OF TRANSPLANT | U | 0 | 20 | MG | VIAL | ||||||
| 126280391 | 12628039 | 4 | SS | SIMULECT | BASILIXIMAB | 1 | U | 0 | VIAL | ||||||||||
| 126280391 | 12628039 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 15 MG/M2, ON DAY ONE AFTER TRANSPLANT | U | 0 | 15 | MG/M**2 | SOLUTION FOR INJECTION | ||||||
| 126280391 | 12628039 | 6 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 10 MG/M2, ON THE THIRD DAY AFTER TRANSPLANT | U | 0 | 10 | MG/M**2 | SOLUTION FOR INJECTION | ||||||
| 126280391 | 12628039 | 7 | SS | ANTITHYMOCYTE IMMUNOGLOBULIN | THYMOCYTE IMMUNE GLOBULIN NOS | 1 | Intravenous drip | 2.5 MG/KG, QD, 2 DAYS BEFORE TRANSPLANT | U | 0 | 2.5 | MG/KG | QD | ||||||
| 126280391 | 12628039 | 8 | SS | ANTITHYMOCYTE IMMUNOGLOBULIN | THYMOCYTE IMMUNE GLOBULIN NOS | 1 | U | 0 | |||||||||||
| 126280391 | 12628039 | 9 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | 0.5 MG, Q12H (STARTING ON DAY 7 BEFORE TRANSPLANTATION) | U | 0 | .5 | MG | Q12H | ||||||
| 126280391 | 12628039 | 10 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126280391 | 12628039 | 1 | Stem cell transplant |
| 126280391 | 12628039 | 2 | Prophylaxis against graft versus host disease |
| 126280391 | 12628039 | 3 | Stem cell transplant |
| 126280391 | 12628039 | 4 | Prophylaxis against graft versus host disease |
| 126280391 | 12628039 | 5 | Stem cell transplant |
| 126280391 | 12628039 | 6 | Prophylaxis against graft versus host disease |
| 126280391 | 12628039 | 7 | Stem cell transplant |
| 126280391 | 12628039 | 8 | Prophylaxis against graft versus host disease |
| 126280391 | 12628039 | 9 | Stem cell transplant |
| 126280391 | 12628039 | 10 | Prophylaxis against graft versus host disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126280391 | 12628039 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126280391 | 12628039 | Acute graft versus host disease | |
| 126280391 | 12628039 | Neutropenia | |
| 126280391 | 12628039 | Urinary tract infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |