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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126235602 | 12623560 | 2 | F | 20160802 | 20160804 | 20160809 | EXP | PHHY2016CN107038 | SANDOZ | 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 | 60.00 | YR | F | Y | 0.00000 | 20160809 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126235602 | 12623560 | 1 | SS | NEORAL | CYCLOSPORINE | 1 | Intravenous (not otherwise specified) | 2.5 MG/KG, QD ON THE DAY BEFORE TRANSPLANTATION | 0 | 2.5 | MG/KG | QD | |||||||
| 126235602 | 12623560 | 2 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 5 MG/KG FOR 3-6 MONTHS | 0 | 5 | MG/KG | ||||||||
| 126235602 | 12623560 | 3 | PS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 15 MG/M2, ON DAY ONE AFTER TRANSPLANTATION | 90029 | 15 | MG/M**2 | ||||||||
| 126235602 | 12623560 | 4 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 10 MG/M2, ON THE THIRD DAY AFTER TRANSPLANTATION | 90029 | 10 | MG/M**2 | ||||||||
| 126235602 | 12623560 | 5 | SS | ANTITHYMOCYTE IMMUNOGLOBULIN | THYMOCYTE IMMUNE GLOBULIN NOS | 1 | Intravenous (not otherwise specified) | 2.5 MG/KG, QD, DRIP FOR 2 DAYS BEFORE TRANSPLANTATION | 0 | 2.5 | MG/KG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126235602 | 12623560 | 1 | Stem cell transplant |
| 126235602 | 12623560 | 2 | Prophylaxis against graft versus host disease |
| 126235602 | 12623560 | 3 | Stem cell transplant |
| 126235602 | 12623560 | 4 | Prophylaxis against graft versus host disease |
| 126235602 | 12623560 | 5 | Prophylaxis against graft versus host disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126235602 | 12623560 | DE |
| 126235602 | 12623560 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126235602 | 12623560 | Acute myeloid leukaemia recurrent | |
| 126235602 | 12623560 | Gastrointestinal infection | |
| 126235602 | 12623560 | Haemorrhage | |
| 126235602 | 12623560 | Neutropenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |