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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126901722 | 12690172 | 2 | F | 20160826 | 20160826 | 20160907 | EXP | US-PFIZER INC-2016390423 | PFIZER | KATSANIS, E.. ALTERNATIVE DONOR HEMATOPOIETIC CELL TRANSPLANTATION CONDITIONED WITH MYELOABLATIVE BUSULFAN, FLUDARABINE, AND MELPHALAN IS WELL TOLERATED AND EFFECTIVE AGAINST HIGH-RISK MYELOID MALIGNANCIES. JOURNAL OF PEDIATRIC HEMATOLOGY/ONCOLOGY. 2016 | 19.00 | YR | M | Y | 0.00000 | 20160907 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126901722 | 12690172 | 1 | PS | FLUDARABINE PHOSPHATE. | FLUDARABINE PHOSPHATE | 1 | 30 MG/M2, UNK (30?4) | U | 77790 | 30 | MG/M**2 | ||||||||
| 126901722 | 12690172 | 2 | SS | BUSULFAN. | BUSULFAN | 1 | Intravenous (not otherwise specified) | 0.8 MG/KG, UNK (EVERY 6 HOURS FOR A TOTAL OF 16 DOSES, DAYS, -9 TO -6) | U | 0 | .8 | MG/KG | |||||||
| 126901722 | 12690172 | 3 | SS | MELPHALAN | MELPHALAN | 1 | 60 MG/M2, UNK (60?3) | U | 0 | 60 | MG/M**2 | ||||||||
| 126901722 | 12690172 | 4 | C | CYCLOSPORINE. | CYCLOSPORINE | 1 | 0 | ||||||||||||
| 126901722 | 12690172 | 5 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126901722 | 12690172 | 1 | Acute lymphocytic leukaemia |
| 126901722 | 12690172 | 2 | Acute lymphocytic leukaemia |
| 126901722 | 12690172 | 3 | Acute lymphocytic leukaemia |
| 126901722 | 12690172 | 4 | Graft versus host disease |
| 126901722 | 12690172 | 5 | Graft versus host disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126901722 | 12690172 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126901722 | 12690172 | Bacteraemia | |
| 126901722 | 12690172 | Mucosal inflammation | |
| 126901722 | 12690172 | Myelodysplastic syndrome | |
| 126901722 | 12690172 | Second primary malignancy |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |