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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112783874 | 11278387 | 4 | F | 2011 | 20160711 | 20150717 | 20160801 | EXP | PHHY2015KR083317 | NOVARTIS | 0.00 | F | Y | 52.00000 | KG | 20160801 | CN | COUNTRY NOT SPECIFIED | KR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112783874 | 11278387 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 400 MG, BID | 22068 | 400 | MG | CAPSULE | BID | ||||||
| 112783874 | 11278387 | 2 | SS | TASIGNA | NILOTINIB | 1 | Oral | 800 MG, BID | 22068 | 800 | MG | CAPSULE | BID | ||||||
| 112783874 | 11278387 | 3 | SS | TASIGNA | NILOTINIB | 1 | Oral | 600 MG, BID | 22068 | 600 | MG | CAPSULE | BID | ||||||
| 112783874 | 11278387 | 4 | SS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, BID | 22068 | 300 | MG | CAPSULE | BID | ||||||
| 112783874 | 11278387 | 5 | SS | GLIVEC | IMATINIB MESYLATE | 1 | Oral | 400 MG, QD | 0 | 400 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112783874 | 11278387 | 1 | Chronic myeloid leukaemia |
| 112783874 | 11278387 | 5 | Chronic myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112783874 | 11278387 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112783874 | 11278387 | Fatigue | |
| 112783874 | 11278387 | Neoplasm malignant | |
| 112783874 | 11278387 | Second primary malignancy | |
| 112783874 | 11278387 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 112783874 | 11278387 | 1 | 201011 | 201607 | 0 | |
| 112783874 | 11278387 | 2 | 201011 | 201607 | 0 | |
| 112783874 | 11278387 | 4 | 201607 | 0 | ||
| 112783874 | 11278387 | 5 | 20081031 | 0 |