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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125684021 | 12568402 | 1 | I | 20160714 | 20160718 | 20160718 | EXP | PHHY2016KR097163 | NOVARTIS | LEE K, KIM H, LEE J, JOO Y, BAE S, LEE SM ET AL.. COMPARABLE ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION OUTCOME OF A HAPLO-IDENTICAL FAMILY DONOR WITH AN ALTERNATIVE DONOR IN ADULT APLASTIC ANEMIA. ACTA HAEMATOLOGICA. 2016;136:129-39 | 34.00 | YR | M | Y | 0.00000 | 20160719 | OT | KR | KR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125684021 | 12568402 | 1 | PS | CICLOSPORIN | CYCLOSPORINE | 1 | Unknown | UNK | 50574 | ||||||||||
| 125684021 | 12568402 | 2 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | Intravenous (not otherwise specified) | 1.5 MG/KG, Q12H (BEGINNING ON DAY -1) | 50574 | 1.5 | MG/KG | Q12H | |||||||
| 125684021 | 12568402 | 3 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | 50574 | ||||||||||||
| 125684021 | 12568402 | 4 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 15 MG/M2, (ON DAY 2) | 0 | 15 | MG/M**2 | ||||||||
| 125684021 | 12568402 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 10 MG/M2, (ON DAYS 4, 7 AND 12) | 0 | 10 | MG/M**2 | ||||||||
| 125684021 | 12568402 | 6 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | 30 MG/M2, QD (ON DAYS -7 TO -2) | 0 | 30 | MG/M**2 | QD | |||||||
| 125684021 | 12568402 | 7 | SS | ANTITHYMOCYTE IMMUNOGLOBULIN | THYMOCYTE IMMUNE GLOBULIN NOS | 1 | Unknown | UNK | 0 | ||||||||||
| 125684021 | 12568402 | 8 | SS | ANTITHYMOCYTE IMMUNOGLOBULIN | THYMOCYTE IMMUNE GLOBULIN NOS | 1 | Intravenous (not otherwise specified) | 3 MG/KG, QD (DAYS -4 TO -1) | 0 | 3 | MG/KG | QD | |||||||
| 125684021 | 12568402 | 9 | SS | BUSULFAN. | BUSULFAN | 1 | Intravenous (not otherwise specified) | 3.2 MG/KG, QD (ON DAYS -7 AND -6) | 0 | 3.2 | MG/KG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125684021 | 12568402 | 1 | Aplastic anaemia |
| 125684021 | 12568402 | 2 | Stem cell transplant |
| 125684021 | 12568402 | 3 | Prophylaxis against graft versus host disease |
| 125684021 | 12568402 | 4 | Stem cell transplant |
| 125684021 | 12568402 | 5 | Prophylaxis against graft versus host disease |
| 125684021 | 12568402 | 6 | Bone marrow conditioning regimen |
| 125684021 | 12568402 | 7 | Aplastic anaemia |
| 125684021 | 12568402 | 8 | Bone marrow conditioning regimen |
| 125684021 | 12568402 | 9 | Bone marrow conditioning regimen |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125684021 | 12568402 | OT |
| 125684021 | 12568402 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125684021 | 12568402 | Blood stem cell transplant failure | |
| 125684021 | 12568402 | Product use issue | |
| 125684021 | 12568402 | Therapy non-responder |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |