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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115645144 | 11564514 | 4 | F | 20140826 | 20160701 | 20150928 | 20160707 | EXP | PHHO2015BE014501 | NOVARTIS | 39.53 | YR | M | Y | 0.00000 | 20160707 | MD | BE | BE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115645144 | 11564514 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, BID | 495600 | MG | 22068 | 300 | MG | CAPSULE | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115645144 | 11564514 | 1 | Chronic myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115645144 | 11564514 | HO |
| 115645144 | 11564514 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115645144 | 11564514 | Asthenia | |
| 115645144 | 11564514 | Back pain | |
| 115645144 | 11564514 | Fatigue | |
| 115645144 | 11564514 | Intervertebral disc protrusion | |
| 115645144 | 11564514 | Monoparesis | |
| 115645144 | 11564514 | Muscle spasms | |
| 115645144 | 11564514 | Myalgia | |
| 115645144 | 11564514 | Pain in extremity | |
| 115645144 | 11564514 | Peripheral swelling | |
| 115645144 | 11564514 | Postoperative wound infection | |
| 115645144 | 11564514 | Rash | |
| 115645144 | 11564514 | Stress |
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 |
|---|---|---|---|---|---|---|
| 115645144 | 11564514 | 1 | 20130522 | 20150825 | 0 |