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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126774231 | 12677423 | 1 | I | 20160816 | 20160823 | 20160823 | EXP | US-CELGENEUS-USA-2016084251 | CELGENE | CHOBADI A. PHASE I STUDY OF AZACITDINE FOLLOWING DONOR LYMPHOCYTE INFUSION FOR RELAPSED ACUTE MYELOID LEUKEMIA POST ALLOGENEIC STEM CELL TRANSPLANTATION.. LEUKEMIA RESEARCH. 2016 JUL 22;. | 0.00 | Y | 0.00000 | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126774231 | 12677423 | 1 | PS | VIDAZA | AZACITIDINE | 1 | Intravenous drip | U | U | 50794 | 45 | MG/M**2 | INJECTION | ||||||
| 126774231 | 12677423 | 2 | SS | VIDAZA | AZACITIDINE | 1 | Intravenous drip | U | U | 50794 | 75 | MG/M**2 | INJECTION | ||||||
| 126774231 | 12677423 | 3 | C | G-CSF | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Unknown | 0 | 5 | UG/KG | UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126774231 | 12677423 | 1 | Acute myeloid leukaemia |
| 126774231 | 12677423 | 3 | Neutropenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126774231 | 12677423 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126774231 | 12677423 | Alanine aminotransferase increased | |
| 126774231 | 12677423 | Decreased appetite | |
| 126774231 | 12677423 | Diarrhoea | |
| 126774231 | 12677423 | Encephalopathy | |
| 126774231 | 12677423 | Febrile neutropenia | |
| 126774231 | 12677423 | Graft versus host disease | |
| 126774231 | 12677423 | Hepatic function abnormal | |
| 126774231 | 12677423 | Hypoalbuminaemia | |
| 126774231 | 12677423 | Hypocalcaemia | |
| 126774231 | 12677423 | Hypokalaemia | |
| 126774231 | 12677423 | Hyponatraemia | |
| 126774231 | 12677423 | Hypophosphataemia | |
| 126774231 | 12677423 | Opportunistic infection | |
| 126774231 | 12677423 | Sepsis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |