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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127123871 | 12712387 | 1 | I | 20141120 | 20160902 | 20160902 | EXP | JP-CELGENEUS-JPN-2014113581 | CELGENE | KATSUMICHI F. EFFICACY AND SAFETY OF A 5-DAY REGIMEN OF AZACITIDINE FOR PATIENTS WITH HIGH-RISK MYELODYSPLASTIC SYNDROMES. EUROPEAN JOURNAL OF HAEMATOLOGY. 2016;97:228-231. | 0.00 | Y | 0.00000 | 20160902 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127123871 | 12712387 | 1 | PS | VIDAZA | AZACITIDINE | 1 | Unknown | U | U | 50794 | 75 | MG/M**2 | INJECTION | ||||||
| 127123871 | 12712387 | 2 | SS | VIDAZA | AZACITIDINE | 1 | Unknown | U | U | 50794 | 75 | MG/M**2 | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127123871 | 12712387 | 1 | Myelodysplastic syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127123871 | 12712387 | DE |
| 127123871 | 12712387 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127123871 | 12712387 | Death | |
| 127123871 | 12712387 | Febrile neutropenia | |
| 127123871 | 12712387 | Gastrointestinal haemorrhage | |
| 127123871 | 12712387 | Leukaemia | |
| 127123871 | 12712387 | Neutropenia | |
| 127123871 | 12712387 | Pneumonia | |
| 127123871 | 12712387 | Rash | |
| 127123871 | 12712387 | Sepsis | |
| 127123871 | 12712387 | Thrombocytopenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 127123871 | 12712387 | 1 | 201104 | 201312 | 0 | |
| 127123871 | 12712387 | 2 | 201104 | 201312 | 0 |