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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1172243214 | 11722432 | 14 | F | 20151001 | 20160802 | 20151111 | 20160809 | EXP | PHHY2015IQ142644 | NOVARTIS | 0.00 | A | M | Y | 0.00000 | 20160809 | MD | IQ | IQ |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1172243214 | 11722432 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 800 MG, QD (IN ONE INTAKE WITH FOOD) | 22068 | 800 | MG | CAPSULE | QD | ||||||
| 1172243214 | 11722432 | 2 | SS | TASIGNA | NILOTINIB | 1 | Oral | 800 MG, QD | 22068 | 800 | MG | CAPSULE | QD | ||||||
| 1172243214 | 11722432 | 3 | SS | TASIGNA | NILOTINIB | 1 | Oral | 800 MG, QD | 22068 | 800 | MG | CAPSULE | QD | ||||||
| 1172243214 | 11722432 | 4 | SS | TASIGNA | NILOTINIB | 1 | Oral | 400 MG, QD | 22068 | 400 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1172243214 | 11722432 | 1 | Chronic myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1172243214 | 11722432 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1172243214 | 11722432 | Abdominal distension | |
| 1172243214 | 11722432 | Abdominal pain | |
| 1172243214 | 11722432 | Chest pain | |
| 1172243214 | 11722432 | Decreased appetite | |
| 1172243214 | 11722432 | Epistaxis | |
| 1172243214 | 11722432 | Fatigue | |
| 1172243214 | 11722432 | Food interaction | |
| 1172243214 | 11722432 | Headache | |
| 1172243214 | 11722432 | Hyperglycaemia | |
| 1172243214 | 11722432 | Kidney infection | |
| 1172243214 | 11722432 | Pollakiuria | |
| 1172243214 | 11722432 | Thrombocytopenia | |
| 1172243214 | 11722432 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 1172243214 | 11722432 | 1 | 20151001 | 20151104 | 0 | |
| 1172243214 | 11722432 | 2 | 201512 | 20160307 | 0 | |
| 1172243214 | 11722432 | 3 | 201605 | 201607 | 0 | |
| 1172243214 | 11722432 | 4 | 201607 | 0 |