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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 83859992 | 8385999 | 2 | F | 20160829 | 20120202 | 20160906 | EXP | PHHY2012GR008369 | NOVARTIS | ANGELOPOULOU MK, ASIMAKOPOULOS JV, GALANI Z, LEVIDOU G, ROUMELIOTI M, ASSILAKOPOULOS TP ET AL.. EXTRAMEDULLARY SUDDEN BLAST CRISIS IN CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA DURING FIRST-LINE TREATMENT WITH NILOTINIB. BLOOD CANCER JOURNAL. 2016;6:E461 | 0.00 | A | F | Y | 0.00000 | 20160906 | OT | GR | GR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 83859992 | 8385999 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, BID | 22068 | 300 | MG | CAPSULE | BID | ||||||
| 83859992 | 8385999 | 2 | SS | TASIGNA | NILOTINIB | 1 | Oral | 150 MG, BID | 22068 | 150 | MG | CAPSULE | BID | ||||||
| 83859992 | 8385999 | 3 | SS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, BID | 22068 | 300 | MG | CAPSULE | BID | ||||||
| 83859992 | 8385999 | 4 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | 0 | |||||||||||
| 83859992 | 8385999 | 5 | SS | IDARUBICIN | IDARUBICIN | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 83859992 | 8385999 | 1 | Chronic myeloid leukaemia |
| 83859992 | 8385999 | 4 | Acute myeloid leukaemia |
| 83859992 | 8385999 | 5 | Acute myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 83859992 | 8385999 | OT |
| 83859992 | 8385999 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 83859992 | 8385999 | Abdominal pain lower | |
| 83859992 | 8385999 | Acute myeloid leukaemia | |
| 83859992 | 8385999 | Blast crisis in myelogenous leukaemia | |
| 83859992 | 8385999 | Bone marrow disorder | |
| 83859992 | 8385999 | Bone pain | |
| 83859992 | 8385999 | Chloroma | |
| 83859992 | 8385999 | Decreased appetite | |
| 83859992 | 8385999 | Drug ineffective | |
| 83859992 | 8385999 | Haematotoxicity | |
| 83859992 | 8385999 | Lymphadenopathy | |
| 83859992 | 8385999 | Sarcoma | |
| 83859992 | 8385999 | Sepsis | |
| 83859992 | 8385999 | Weight decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |