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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 92809772 | 9280977 | 2 | F | 20160712 | 20130509 | 20160725 | EXP | DE-CELGENEUS-062-50794-13044964 | CELGENE | WEHMEYER J, ZAISS M, LOSEM C, SCHMITZ S, NIEMEIER B, HARDE J. IMPACT OF ECOG AND TRANSFUSION DEPENDENCE IN PATIENTS WITH HIGH RISK MYELODYSPLASTIC SYNDROME TREATED WITH AZACITIDINE: RESULTS FROM THE NON-INTERVENTIONAL STUDY PIAZA. | 0.00 | Y | 0.00000 | 20160725 | OT | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 92809772 | 9280977 | 1 | PS | VIDAZA | AZACITIDINE | 1 | Subcutaneous | 75 MILLIGRAM/SQ. METER | U | U | 50794 | 75 | MG/M**2 | INJECTION | QD | ||||
| 92809772 | 9280977 | 2 | SS | VIDAZA | AZACITIDINE | 1 | U | U | 50794 | ||||||||||
| 92809772 | 9280977 | 3 | SS | VIDAZA | AZACITIDINE | 1 | U | U | 50794 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 92809772 | 9280977 | 1 | Myelodysplastic syndrome |
| 92809772 | 9280977 | 2 | Acute myeloid leukaemia |
| 92809772 | 9280977 | 3 | Chronic myelomonocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 92809772 | 9280977 | DE |
| 92809772 | 9280977 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 92809772 | 9280977 | Acute abdomen | |
| 92809772 | 9280977 | Alopecia | |
| 92809772 | 9280977 | Anaemia | |
| 92809772 | 9280977 | Blood disorder | |
| 92809772 | 9280977 | Constipation | |
| 92809772 | 9280977 | Death | |
| 92809772 | 9280977 | Diarrhoea | |
| 92809772 | 9280977 | Diverticulitis | |
| 92809772 | 9280977 | Fatigue | |
| 92809772 | 9280977 | Gastrointestinal disorder | |
| 92809772 | 9280977 | General physical health deterioration | |
| 92809772 | 9280977 | Granulocytopenia | |
| 92809772 | 9280977 | Infection | |
| 92809772 | 9280977 | Leukocytosis | |
| 92809772 | 9280977 | Leukopenia | |
| 92809772 | 9280977 | Myelodysplastic syndrome | |
| 92809772 | 9280977 | Nausea | |
| 92809772 | 9280977 | Neutropenia | |
| 92809772 | 9280977 | Night sweats | |
| 92809772 | 9280977 | Pancytopenia | |
| 92809772 | 9280977 | Pneumonia | |
| 92809772 | 9280977 | Pyrexia | |
| 92809772 | 9280977 | Rash | |
| 92809772 | 9280977 | Septic shock | |
| 92809772 | 9280977 | Skin disorder | |
| 92809772 | 9280977 | Thrombocytopenia | |
| 92809772 | 9280977 | Toothache | |
| 92809772 | 9280977 | Toxicity to various agents | |
| 92809772 | 9280977 | Unevaluable event | |
| 92809772 | 9280977 | Vomiting | |
| 92809772 | 9280977 | Weight decreased | |
| 92809772 | 9280977 | Weight fluctuation |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |