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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126280431 | 12628043 | 1 | I | 20121008 | 20160807 | 20160807 | EXP | PHHY2012CN089507 | NOVARTIS | LOU Y, ZHNAG P, SHANG Y, LOU SF, ZHOU K, CHEN S AND ET AL.. ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION FOLLOWED BY SEQUENTIAL INFUSION OF DONOR-DERIVED CYTOKINE INDUCED KILLER CELLS FOR RELAPSED/REFRACTORY HEMATOLOGIC MALIGNANCY: A PRELIMINARY STUDY OF 9 CASES. TUMOR. 2012;32(7):546-50 | 48.00 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126280431 | 12628043 | 1 | PS | NEORAL | CYCLOSPORINE | 1 | Intravenous (not otherwise specified) | 2.5 MG/KG, QD | U | 50715 | 2.5 | MG/KG | QD | ||||||
| 126280431 | 12628043 | 2 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 5 MG/KG, UNK | U | 50715 | 5 | MG/KG | |||||||
| 126280431 | 12628043 | 3 | SS | NEORAL | CYCLOSPORINE | 1 | U | 50715 | |||||||||||
| 126280431 | 12628043 | 4 | SS | SIMULECT | BASILIXIMAB | 1 | Unknown | 20 MG, ONCE/SINGLE | U | 0 | 20 | MG | 1X | ||||||
| 126280431 | 12628043 | 5 | SS | SIMULECT | BASILIXIMAB | 1 | U | 0 | |||||||||||
| 126280431 | 12628043 | 6 | SS | SIMULECT | BASILIXIMAB | 1 | U | 0 | |||||||||||
| 126280431 | 12628043 | 7 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 15 MG/M2, ONCE/SINGLE ON DAY +1 | U | 0 | 15 | MG/M**2 | CONCENTRATE FOR SOLUTION FOR INJECTION | 1X | |||||
| 126280431 | 12628043 | 8 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 10 MG/M2, ONCE/SINGLE ON DAY +3 | U | 0 | 10 | MG/M**2 | CONCENTRATE FOR SOLUTION FOR INJECTION | 1X | |||||
| 126280431 | 12628043 | 9 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 10 MG/M2, ONCE/SINGLE ON DAY +7 | U | 0 | 10 | MG/M**2 | CONCENTRATE FOR SOLUTION FOR INJECTION | 1X | |||||
| 126280431 | 12628043 | 10 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | 0.5 G, BID | U | 0 | .5 | G | CAPSULE | BID | |||||
| 126280431 | 12628043 | 11 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | U | 0 | CAPSULE | ||||||||||
| 126280431 | 12628043 | 12 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | U | 0 | CAPSULE | ||||||||||
| 126280431 | 12628043 | 13 | C | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | 30 MG/M2, UNK | U | 0 | 30 | MG/M**2 | |||||||
| 126280431 | 12628043 | 14 | C | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | U | 0 | ||||||||||
| 126280431 | 12628043 | 15 | C | BUSULFAN. | BUSULFAN | 1 | Unknown | U | 0 | TABLET | |||||||||
| 126280431 | 12628043 | 16 | C | ANTITHYMOCYTE IMMUNOGLOBULIN | THYMOCYTE IMMUNE GLOBULIN NOS | 1 | Intravenous drip | 2.5 MG/KG, QD | U | 0 | 2.5 | MG/KG | QD | ||||||
| 126280431 | 12628043 | 17 | C | SULFAMETHOXAZOLE | SULFAMETHOXAZOLE | 1 | Unknown | 0 | TABLET | ||||||||||
| 126280431 | 12628043 | 18 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Unknown | 0 | TABLET | ||||||||||
| 126280431 | 12628043 | 19 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Unknown | 0 | TABLET | ||||||||||
| 126280431 | 12628043 | 20 | C | ALPROSTADIL. | ALPROSTADIL | 1 | Unknown | 0 | |||||||||||
| 126280431 | 12628043 | 21 | C | HEPARIN | HEPARIN SODIUM | 1 | Unknown | 0 | |||||||||||
| 126280431 | 12628043 | 22 | C | URSODEOXYCHOLIC ACID | URSODIOL | 1 | Unknown | 0 | |||||||||||
| 126280431 | 12628043 | 23 | C | MESNA. | MESNA | 1 | Unknown | 0 | |||||||||||
| 126280431 | 12628043 | 24 | C | FILGRASTIM | FILGRASTIM | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126280431 | 12628043 | 1 | Stem cell transplant |
| 126280431 | 12628043 | 2 | Prophylaxis against graft versus host disease |
| 126280431 | 12628043 | 3 | Immunosuppressant drug therapy |
| 126280431 | 12628043 | 4 | Stem cell transplant |
| 126280431 | 12628043 | 5 | Prophylaxis against graft versus host disease |
| 126280431 | 12628043 | 6 | Immunosuppressant drug therapy |
| 126280431 | 12628043 | 7 | Stem cell transplant |
| 126280431 | 12628043 | 8 | Prophylaxis against graft versus host disease |
| 126280431 | 12628043 | 9 | Immunosuppressant drug therapy |
| 126280431 | 12628043 | 10 | Stem cell transplant |
| 126280431 | 12628043 | 11 | Prophylaxis against graft versus host disease |
| 126280431 | 12628043 | 12 | Immunosuppressant drug therapy |
| 126280431 | 12628043 | 13 | Bone marrow conditioning regimen |
| 126280431 | 12628043 | 14 | Bone marrow conditioning regimen |
| 126280431 | 12628043 | 15 | Bone marrow conditioning regimen |
| 126280431 | 12628043 | 16 | Bone marrow conditioning regimen |
| 126280431 | 12628043 | 17 | Prophylaxis |
| 126280431 | 12628043 | 18 | Prophylaxis |
| 126280431 | 12628043 | 19 | Prophylaxis |
| 126280431 | 12628043 | 20 | Prophylaxis |
| 126280431 | 12628043 | 21 | Prophylaxis |
| 126280431 | 12628043 | 22 | Prophylaxis |
| 126280431 | 12628043 | 23 | Prophylaxis |
| 126280431 | 12628043 | 24 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126280431 | 12628043 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126280431 | 12628043 | Neutropenia | |
| 126280431 | 12628043 | Stomatitis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |