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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126235571 | 12623557 | 1 | I | 20121008 | 20160804 | 20160804 | EXP | PHHY2012CN089490 | 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 1 STUDY IN PATIENTS WITH RELAPSED/REFRACTORY HEMATOLOGIC MALIGNANCIES. LEUKEMIA RESEARCH. 2016;48:6-10 | 45.00 | YR | M | Y | 0.00000 | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126235571 | 12623557 | 1 | PS | NEORAL | CYCLOSPORINE | 1 | Intravenous (not otherwise specified) | 2.5 MG/KG, QD | 50715 | 2.5 | MG/KG | QD | |||||||
| 126235571 | 12623557 | 2 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 5 MG/KG, UNK | 50715 | 5 | MG/KG | ||||||||
| 126235571 | 12623557 | 3 | SS | NEORAL | CYCLOSPORINE | 1 | 50715 | ||||||||||||
| 126235571 | 12623557 | 4 | SS | NEORAL | CYCLOSPORINE | 1 | 50715 | ||||||||||||
| 126235571 | 12623557 | 5 | SS | SIMULECT | BASILIXIMAB | 1 | Unknown | 20 MG, UNK | 0 | 20 | MG | ||||||||
| 126235571 | 12623557 | 6 | SS | SIMULECT | BASILIXIMAB | 1 | 0 | ||||||||||||
| 126235571 | 12623557 | 7 | SS | SIMULECT | BASILIXIMAB | 1 | 0 | ||||||||||||
| 126235571 | 12623557 | 8 | SS | SIMULECT | BASILIXIMAB | 1 | 0 | ||||||||||||
| 126235571 | 12623557 | 9 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 15 MG/M2, ON DAY +1 | 0 | 15 | MG/M**2 | CONCENTRATE FOR SOLUTION FOR INJECTION | |||||||
| 126235571 | 12623557 | 10 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 10 MG/M2, ON DAY +3 AND DAY +7 | 0 | 10 | MG/M**2 | CONCENTRATE FOR SOLUTION FOR INJECTION | |||||||
| 126235571 | 12623557 | 11 | SS | METHOTREXATE. | METHOTREXATE | 1 | 0 | CONCENTRATE FOR SOLUTION FOR INJECTION | |||||||||||
| 126235571 | 12623557 | 12 | SS | METHOTREXATE. | METHOTREXATE | 1 | 0 | CONCENTRATE FOR SOLUTION FOR INJECTION | |||||||||||
| 126235571 | 12623557 | 13 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | 0.5 G, BID | 0 | .5 | G | CAPSULE | BID | ||||||
| 126235571 | 12623557 | 14 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | 0 | CAPSULE | |||||||||||
| 126235571 | 12623557 | 15 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | 0 | CAPSULE | |||||||||||
| 126235571 | 12623557 | 16 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | 0 | CAPSULE | |||||||||||
| 126235571 | 12623557 | 17 | C | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | 30 MG/M2, UNK | 0 | 30 | MG/M**2 | INJECTION | |||||||
| 126235571 | 12623557 | 18 | C | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 0 | INJECTION | ||||||||||
| 126235571 | 12623557 | 19 | C | BUSULFAN. | BUSULFAN | 1 | Unknown | 0 | TABLET | ||||||||||
| 126235571 | 12623557 | 20 | C | ANTITHYMOCYTE IMMUNOGLOBULIN | THYMOCYTE IMMUNE GLOBULIN NOS | 1 | Intravenous drip | 2.5 MG/KG, QD | 0 | 2.5 | MG/KG | INJECTION | QD | ||||||
| 126235571 | 12623557 | 21 | C | SULFAMETHOXAZOLE | SULFAMETHOXAZOLE | 1 | Unknown | 0 | TABLET | ||||||||||
| 126235571 | 12623557 | 22 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Unknown | 0 | TABLET | ||||||||||
| 126235571 | 12623557 | 23 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Unknown | 0 | TABLET | ||||||||||
| 126235571 | 12623557 | 24 | C | ALPROSTADIL. | ALPROSTADIL | 1 | Unknown | 0 | |||||||||||
| 126235571 | 12623557 | 25 | C | HEPARIN | HEPARIN SODIUM | 1 | Unknown | 0 | |||||||||||
| 126235571 | 12623557 | 26 | C | URSODEOXYCHOLIC ACID | URSODIOL | 1 | Unknown | 0 | TABLET | ||||||||||
| 126235571 | 12623557 | 27 | C | MESNA. | MESNA | 1 | Unknown | 0 | |||||||||||
| 126235571 | 12623557 | 28 | C | FILGRASTIM | FILGRASTIM | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126235571 | 12623557 | 1 | Stem cell transplant |
| 126235571 | 12623557 | 2 | Bone marrow transplant |
| 126235571 | 12623557 | 3 | Prophylaxis against graft versus host disease |
| 126235571 | 12623557 | 4 | Immunosuppressant drug therapy |
| 126235571 | 12623557 | 5 | Stem cell transplant |
| 126235571 | 12623557 | 6 | Bone marrow transplant |
| 126235571 | 12623557 | 7 | Prophylaxis against graft versus host disease |
| 126235571 | 12623557 | 8 | Immunosuppressant drug therapy |
| 126235571 | 12623557 | 9 | Bone marrow transplant |
| 126235571 | 12623557 | 10 | Stem cell transplant |
| 126235571 | 12623557 | 11 | Prophylaxis against graft versus host disease |
| 126235571 | 12623557 | 12 | Immunosuppressant drug therapy |
| 126235571 | 12623557 | 13 | Prophylaxis against graft versus host disease |
| 126235571 | 12623557 | 14 | Stem cell transplant |
| 126235571 | 12623557 | 15 | Bone marrow transplant |
| 126235571 | 12623557 | 16 | Immunosuppressant drug therapy |
| 126235571 | 12623557 | 17 | Bone marrow conditioning regimen |
| 126235571 | 12623557 | 18 | Bone marrow conditioning regimen |
| 126235571 | 12623557 | 19 | Bone marrow conditioning regimen |
| 126235571 | 12623557 | 20 | Bone marrow conditioning regimen |
| 126235571 | 12623557 | 21 | Prophylaxis |
| 126235571 | 12623557 | 22 | Prophylaxis |
| 126235571 | 12623557 | 23 | Prophylaxis |
| 126235571 | 12623557 | 24 | Prophylaxis |
| 126235571 | 12623557 | 25 | Prophylaxis |
| 126235571 | 12623557 | 26 | Prophylaxis |
| 126235571 | 12623557 | 27 | Prophylaxis |
| 126235571 | 12623557 | 28 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126235571 | 12623557 | OT |
| 126235571 | 12623557 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126235571 | 12623557 | Chronic myeloid leukaemia recurrent | |
| 126235571 | 12623557 | Pneumonia | |
| 126235571 | 12623557 | Stomatitis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |