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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125825364 | 12582536 | 4 | F | 20160229 | 20160830 | 20160722 | 20160906 | EXP | PHHY2016IT097534 | NOVARTIS | 0.00 | A | M | Y | 0.00000 | 20160906 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125825364 | 12582536 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, BID | Y | 22068 | 300 | MG | CAPSULE | BID | |||||
| 125825364 | 12582536 | 2 | SS | TASIGNA | NILOTINIB | 1 | Oral | 450 MG, QD | Y | 22068 | 450 | MG | CAPSULE | QD | |||||
| 125825364 | 12582536 | 3 | SS | TASIGNA | NILOTINIB | 1 | Oral | 600 MG, QD | Y | 22068 | 600 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125825364 | 12582536 | 1 | Chronic myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125825364 | 12582536 | HO |
| 125825364 | 12582536 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125825364 | 12582536 | Amylase increased | |
| 125825364 | 12582536 | Anaemia | |
| 125825364 | 12582536 | Bone marrow failure | |
| 125825364 | 12582536 | Lipase increased | |
| 125825364 | 12582536 | Liver injury | |
| 125825364 | 12582536 | Neutropenia | |
| 125825364 | 12582536 | 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 |
|---|---|---|---|---|---|---|
| 125825364 | 12582536 | 1 | 20160219 | 20160301 | 0 | |
| 125825364 | 12582536 | 2 | 20160307 | 0 | ||
| 125825364 | 12582536 | 3 | 20160520 | 0 |