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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127727961 | 12772796 | 1 | I | 20160919 | 20160922 | 20160922 | EXP | PHHY2016CN129576 | NOVARTIS | HUI-REN C, ZHI G, CHUN T, XIAO-DONG L, KAI Y, XUE-PENG H ET AL.. HIGH-DOSE CYCLOPHOSPHAMIDE-INDUCED IMMUNOGENIC TOLERANCE FOLLOWING HAPLOIDENTICAL ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION IN SEVERE APLASTIC ANEMIA CHILDREN. CHINESE JOURNAL OF TISSUE ENGINEERING RESEARCH. 2016;20 (32):4818-24 | 3.00 | YR | M | Y | 0.00000 | 20160922 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127727961 | 12772796 | 1 | PS | CICLOSPORIN | CYCLOSPORINE | 1 | Oral | 2.5 MG/KG, QD | D | 50574 | 2.5 | MG/KG | QD | ||||||
| 127727961 | 12772796 | 2 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | D | 50574 | |||||||||||
| 127727961 | 12772796 | 3 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 0.5-1.0 G/D | D | 0 | .1 | G | QD | ||||||
| 127727961 | 12772796 | 4 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | D | 0 | |||||||||||
| 127727961 | 12772796 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 5-10 MG ON + 1 D, + 3D, + 6D AND + 11D | D | 0 | 10 | MG | |||||||
| 127727961 | 12772796 | 6 | SS | METHOTREXATE. | METHOTREXATE | 1 | D | 0 | |||||||||||
| 127727961 | 12772796 | 7 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 0.1 MG/KG, QD | D | 0 | .1 | MG/KG | QD | ||||||
| 127727961 | 12772796 | 8 | SS | TACROLIMUS. | TACROLIMUS | 1 | D | 0 | |||||||||||
| 127727961 | 12772796 | 9 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 14.5 MG/KG, QD FOR CONSECUTIVE 2D | D | 0 | 14.5 | MG/KG | QD | ||||||
| 127727961 | 12772796 | 10 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 50 MG/KG, QD 3 DAYS AFTER TRANSPLANTATION | D | 0 | 50 | MG/KG | QD | ||||||
| 127727961 | 12772796 | 11 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | 30 MG/M2, QD FOR CONSECUTIVE 4D | D | 0 | 30 | MG/M**2 | QD | ||||||
| 127727961 | 12772796 | 12 | SS | BUSULFEX | BUSULFAN | 1 | Unknown | 3.2 MG/KG, QD FOR 1D | D | 0 | 3.2 | MG/KG | QD | ||||||
| 127727961 | 12772796 | 13 | SS | ANTILYMPHOCYTE IMMUNOGLOBULIN | THYMOCYTE IMMUNE GLOBULIN NOS | 1 | Unknown | 1.25 MG/KG, UFOR CONSECUTIVE 2D | D | 0 | 1.25 | MG/KG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127727961 | 12772796 | 1 | Stem cell transplant |
| 127727961 | 12772796 | 2 | Prophylaxis against graft versus host disease |
| 127727961 | 12772796 | 3 | Stem cell transplant |
| 127727961 | 12772796 | 4 | Prophylaxis against graft versus host disease |
| 127727961 | 12772796 | 5 | Stem cell transplant |
| 127727961 | 12772796 | 6 | Prophylaxis against graft versus host disease |
| 127727961 | 12772796 | 7 | Prophylaxis against graft versus host disease |
| 127727961 | 12772796 | 8 | Stem cell transplant |
| 127727961 | 12772796 | 9 | Immune tolerance induction |
| 127727961 | 12772796 | 11 | Product used for unknown indication |
| 127727961 | 12772796 | 12 | Product used for unknown indication |
| 127727961 | 12772796 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127727961 | 12772796 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127727961 | 12772796 | Graft versus host disease in gastrointestinal tract | |
| 127727961 | 12772796 | Pneumonia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |