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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 88354513 | 8835451 | 3 | F | 20160802 | 20121011 | 20160810 | EXP | PHHY2012CN088952 | 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 1 STUDY IN PATIENTS WITH RELAPSED/REFRACTORY HEMATOLOGIC MALIGNANCIES. LEUKEMIA RESEARCH. 2016;48:6-10 | 42.00 | YR | F | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 88354513 | 8835451 | 1 | SS | NEORAL | CYCLOSPORINE | 1 | Intravenous (not otherwise specified) | 2.5 MG/KG, QD | 0 | 2.5 | MG/KG | QD | |||||||
| 88354513 | 8835451 | 2 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 5 MG/KG, UNK | 0 | 5 | MG/KG | ||||||||
| 88354513 | 8835451 | 3 | SS | NEORAL | CYCLOSPORINE | 1 | 0 | ||||||||||||
| 88354513 | 8835451 | 4 | SS | SIMULECT | BASILIXIMAB | 1 | Unknown | 20 MG, UNK | 0 | 20 | MG | ||||||||
| 88354513 | 8835451 | 5 | SS | SIMULECT | BASILIXIMAB | 1 | 0 | ||||||||||||
| 88354513 | 8835451 | 6 | SS | SIMULECT | BASILIXIMAB | 1 | 0 | ||||||||||||
| 88354513 | 8835451 | 7 | PS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 15 MG/M2, ON DAY +1 | U | 90029 | 15 | MG/M**2 | |||||||
| 88354513 | 8835451 | 8 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 10 MG/M2, ON DAY +3 AND DAY +7 | U | 90029 | 10 | MG/M**2 | |||||||
| 88354513 | 8835451 | 9 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | 0.5 G, BID | 0 | .5 | G | CAPSULE | BID | ||||||
| 88354513 | 8835451 | 10 | C | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | 30 MG/M2, UNK | 0 | 30 | MG/M**2 | ||||||||
| 88354513 | 8835451 | 11 | C | BUSULFAN. | BUSULFAN | 1 | Oral | 4 MG/KG, QD | 0 | 4 | MG/KG | TABLET | QD | ||||||
| 88354513 | 8835451 | 12 | C | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 60 MG/KG, QD | 0 | 60 | MG/KG | QD | |||||||
| 88354513 | 8835451 | 13 | C | LOMUSTINE. | LOMUSTINE | 1 | Oral | 200 MG/M2, UNK | 0 | 200 | MG/M**2 | ||||||||
| 88354513 | 8835451 | 14 | C | ANTITHYMOCYTE IMMUNOGLOBULIN | THYMOCYTE IMMUNE GLOBULIN NOS | 1 | Intravenous drip | 2.5 MG/KG, QD | 0 | 2.5 | MG/KG | QD | |||||||
| 88354513 | 8835451 | 15 | C | SULFAMETHOXAZOLE | SULFAMETHOXAZOLE | 1 | Unknown | 0 | TABLET | ||||||||||
| 88354513 | 8835451 | 16 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Unknown | 0 | TABLET | ||||||||||
| 88354513 | 8835451 | 17 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Unknown | 0 | TABLET | ||||||||||
| 88354513 | 8835451 | 18 | C | ALPROSTADIL. | ALPROSTADIL | 1 | Unknown | 0 | |||||||||||
| 88354513 | 8835451 | 19 | C | HEPARIN | HEPARIN SODIUM | 1 | Unknown | 0 | |||||||||||
| 88354513 | 8835451 | 20 | C | URSODEOXYCHOLIC ACID | URSODIOL | 1 | Unknown | 0 | TABLET | ||||||||||
| 88354513 | 8835451 | 21 | C | MESNA. | MESNA | 1 | Unknown | 0 | |||||||||||
| 88354513 | 8835451 | 22 | C | FILGRASTIM | FILGRASTIM | 1 | Unknown | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 88354513 | 8835451 | 1 | Stem cell transplant |
| 88354513 | 8835451 | 2 | Prophylaxis against graft versus host disease |
| 88354513 | 8835451 | 3 | Immunosuppressant drug therapy |
| 88354513 | 8835451 | 4 | Stem cell transplant |
| 88354513 | 8835451 | 5 | Prophylaxis against graft versus host disease |
| 88354513 | 8835451 | 6 | Immunosuppressant drug therapy |
| 88354513 | 8835451 | 7 | Prophylaxis against graft versus host disease |
| 88354513 | 8835451 | 9 | Prophylaxis against graft versus host disease |
| 88354513 | 8835451 | 10 | Bone marrow conditioning regimen |
| 88354513 | 8835451 | 11 | Bone marrow conditioning regimen |
| 88354513 | 8835451 | 12 | Bone marrow conditioning regimen |
| 88354513 | 8835451 | 13 | Bone marrow conditioning regimen |
| 88354513 | 8835451 | 14 | Bone marrow conditioning regimen |
| 88354513 | 8835451 | 15 | Prophylaxis |
| 88354513 | 8835451 | 16 | Prophylaxis |
| 88354513 | 8835451 | 17 | Prophylaxis |
| 88354513 | 8835451 | 18 | Prophylaxis |
| 88354513 | 8835451 | 19 | Prophylaxis |
| 88354513 | 8835451 | 20 | Prophylaxis |
| 88354513 | 8835451 | 21 | Prophylaxis |
| 88354513 | 8835451 | 22 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 88354513 | 8835451 | DE |
| 88354513 | 8835451 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 88354513 | 8835451 | Acute graft versus host disease | |
| 88354513 | 8835451 | Cystitis haemorrhagic | |
| 88354513 | 8835451 | Enteritis | |
| 88354513 | 8835451 | Guillain-Barre syndrome | |
| 88354513 | 8835451 | Interstitial lung disease |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |