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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126692231 | 12669223 | 1 | I | 20160804 | 20160819 | 20160819 | EXP | US-APOPHARMA USA, INC.-2016AP010484 | APOTEX | EMMANUEL KATSANIS, LAUREN N. SAPP, LUZ PELAYO-KATSANIS, KATHERINE WHITNEY, YI ZENG, LISA M. KOPP. ALTERNATIVE DONOR HEMATOPOIETIC CELL TRANSPLANTATION CONDITIONED WITH MYELOABLATIVE BUSULFAN, FLUDARABINE, AND MELPHALAN IS WELL TOLERATED AND EFFECTIVE AGAINST HIGH-RISK MYELOID MALIGNANCIES. PEDIATRIC HEMATOLOGY ONCOLOGY. 2016;00 | 6.00 | YR | M | Y | 0.00000 | 20160819 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126692231 | 12669223 | 1 | PS | ALKERAN | MELPHALAN | 1 | Intravenous (not otherwise specified) | 60 MG/M2, QD | U | 20207 | 60 | MG/M**2 | INJECTION | ||||||
| 126692231 | 12669223 | 2 | SS | BUSULFAN. | BUSULFAN | 1 | Intravenous (not otherwise specified) | 0.8 MG/KG, Q.6H | U | 0 | .8 | MG/KG | Q6H | ||||||
| 126692231 | 12669223 | 3 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | 30 MG/M2, QD | U | 0 | 30 | MG/M**2 | |||||||
| 126692231 | 12669223 | 4 | C | CYCLOSPORIN A | CYCLOSPORINE | 1 | Unknown | U | 0 | ||||||||||
| 126692231 | 12669223 | 5 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126692231 | 12669223 | 1 | Stem cell transplant |
| 126692231 | 12669223 | 2 | Stem cell transplant |
| 126692231 | 12669223 | 3 | Stem cell transplant |
| 126692231 | 12669223 | 4 | Prophylaxis against graft versus host disease |
| 126692231 | 12669223 | 5 | Prophylaxis against graft versus host disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126692231 | 12669223 | HO |
| 126692231 | 12669223 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126692231 | 12669223 | Bacteraemia | |
| 126692231 | 12669223 | Fluid retention | |
| 126692231 | 12669223 | Hepatomegaly | |
| 126692231 | 12669223 | Herpes simplex | |
| 126692231 | 12669223 | Liver disorder | |
| 126692231 | 12669223 | Lung disorder | |
| 126692231 | 12669223 | Stomatitis | |
| 126692231 | 12669223 | Weight increased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |