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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 88399283 | 8839928 | 3 | F | 20160802 | 20121015 | 20160810 | EXP | PHHY2012CN089348 | SANDOZ | 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.. TUMOUR. 2012;32(7):546-550 | 21.00 | YR | M | Y | 0.00000 | 20160810 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 88399283 | 8839928 | 1 | SS | NEORAL | CYCLOSPORINE | 1 | Intravenous (not otherwise specified) | 2.5 MG/KG, PER DAY | Y | 0 | 2.5 | MG/KG | QD | ||||||
| 88399283 | 8839928 | 2 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 5 MG/KG, FOR 3-6 MONTHS | Y | 0 | 5 | MG/KG | |||||||
| 88399283 | 8839928 | 3 | SS | NEORAL | CYCLOSPORINE | 1 | Y | 0 | |||||||||||
| 88399283 | 8839928 | 4 | SS | SIMULECT | BASILIXIMAB | 1 | Intravenous (not otherwise specified) | 20 MG, ONCE/SINGLE | U | 0 | 20 | MG | 1X | ||||||
| 88399283 | 8839928 | 5 | PS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 15 MG/M2, ONCE/SINGLE ON DAY +1 | U | 90029 | 15 | MG/M**2 | 1X | ||||||
| 88399283 | 8839928 | 6 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 10 MG/M2, ONCE/SINGLE ON DAY +3 | U | 90029 | 10 | MG/M**2 | 1X | ||||||
| 88399283 | 8839928 | 7 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 10 MG/M2, ONCE/SINGLE ON DAY +7 | U | 90029 | 10 | MG/M**2 | 1X | ||||||
| 88399283 | 8839928 | 8 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | 0.5 G, BID | U | 0 | .5 | G | CAPSULE | BID | |||||
| 88399283 | 8839928 | 9 | C | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Intravenous drip | 30 MG/M2, QD | U | 0 | 30 | MG/M**2 | QD | ||||||
| 88399283 | 8839928 | 10 | C | BUSULFAN. | BUSULFAN | 1 | Oral | 4 MG/KG, PER DAY | U | 0 | 4 | MG/KG | TABLET | QD | |||||
| 88399283 | 8839928 | 11 | C | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 50 MG/KG, PER DAY | U | 0 | 50 | MG/KG | QD | ||||||
| 88399283 | 8839928 | 12 | C | ANTITHYMOCYTE IMMUNOGLOBULIN | THYMOCYTE IMMUNE GLOBULIN NOS | 1 | Intravenous drip | 2.5 MG/KG, PER DAY | U | 0 | 2.5 | MG/KG | QD | ||||||
| 88399283 | 8839928 | 13 | C | SULFAMETHOXAZOLE | SULFAMETHOXAZOLE | 1 | Unknown | U | 0 | TABLET | |||||||||
| 88399283 | 8839928 | 14 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Unknown | U | 0 | TABLET | |||||||||
| 88399283 | 8839928 | 15 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Unknown | U | 0 | TABLET | |||||||||
| 88399283 | 8839928 | 16 | C | ALPROSTADIL. | ALPROSTADIL | 1 | Unknown | U | 0 | ||||||||||
| 88399283 | 8839928 | 17 | C | HEPARIN | HEPARIN SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 88399283 | 8839928 | 18 | C | URSODEOXYCHOLIC ACID | URSODIOL | 1 | Unknown | U | 0 | ||||||||||
| 88399283 | 8839928 | 19 | C | MESNA. | MESNA | 1 | Unknown | U | 0 | ||||||||||
| 88399283 | 8839928 | 20 | C | FILGRASTIM | FILGRASTIM | 1 | Unknown | U | 0 | ||||||||||
| 88399283 | 8839928 | 21 | C | LOMUSTINE. | LOMUSTINE | 1 | Oral | 200 MG/M2, UNK | U | 0 | 200 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 88399283 | 8839928 | 1 | Stem cell transplant |
| 88399283 | 8839928 | 2 | Bone marrow transplant |
| 88399283 | 8839928 | 3 | Prophylaxis against graft versus host disease |
| 88399283 | 8839928 | 4 | Prophylaxis against graft versus host disease |
| 88399283 | 8839928 | 5 | Prophylaxis against graft versus host disease |
| 88399283 | 8839928 | 8 | Prophylaxis against graft versus host disease |
| 88399283 | 8839928 | 9 | Bone marrow conditioning regimen |
| 88399283 | 8839928 | 10 | Bone marrow conditioning regimen |
| 88399283 | 8839928 | 11 | Bone marrow conditioning regimen |
| 88399283 | 8839928 | 12 | Prophylaxis against graft versus host disease |
| 88399283 | 8839928 | 13 | Infection prophylaxis |
| 88399283 | 8839928 | 14 | Infection prophylaxis |
| 88399283 | 8839928 | 15 | Infection prophylaxis |
| 88399283 | 8839928 | 16 | Prophylaxis |
| 88399283 | 8839928 | 17 | Prophylaxis |
| 88399283 | 8839928 | 18 | Prophylaxis |
| 88399283 | 8839928 | 19 | Prophylaxis |
| 88399283 | 8839928 | 20 | Product used for unknown indication |
| 88399283 | 8839928 | 21 | Bone marrow conditioning regimen |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 88399283 | 8839928 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 88399283 | 8839928 | Chronic graft versus host disease in skin | |
| 88399283 | 8839928 | Cystitis haemorrhagic | |
| 88399283 | 8839928 | Neutropenia | |
| 88399283 | 8839928 | 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 |