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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111695199 | 11169519 | 9 | F | 2012 | 20160810 | 20150605 | 20160817 | EXP | PHHY2014KR156750 | NOVARTIS | 0.00 | F | Y | 0.00000 | 20160817 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111695199 | 11169519 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 150 MG, BID | 22068 | 150 | MG | CAPSULE | BID | ||||||
| 111695199 | 11169519 | 2 | SS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, QD | 22068 | 300 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111695199 | 11169519 | 1 | Chronic myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111695199 | 11169519 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111695199 | 11169519 | Cerebral infarction | |
| 111695199 | 11169519 | Cholelithiasis | |
| 111695199 | 11169519 | Confusional state | |
| 111695199 | 11169519 | Decreased appetite | |
| 111695199 | 11169519 | Dizziness | |
| 111695199 | 11169519 | Incorrect dose administered |
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 |
|---|---|---|---|---|---|---|
| 111695199 | 11169519 | 1 | 2012 | 0 | ||
| 111695199 | 11169519 | 2 | 20120330 | 0 |