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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113636042 | 11363604 | 2 | F | 20140801 | 20160801 | 20150811 | 20160808 | EXP | PHHY2014VE144499 | NOVARTIS | 43.74 | YR | F | Y | 0.00000 | 20160808 | CN | COUNTRY NOT SPECIFIED | VE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113636042 | 11363604 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 800 MG, QD | Y | 22068 | 800 | MG | CAPSULE | QD | |||||
| 113636042 | 11363604 | 2 | SS | TASIGNA | NILOTINIB | 1 | Unknown | 400 MG, QD | Y | 22068 | 400 | MG | CAPSULE | QD | |||||
| 113636042 | 11363604 | 3 | C | PROFENID | KETOPROFEN | 1 | Unknown | 150 MG, QD | U | 0 | 150 | MG | QD | ||||||
| 113636042 | 11363604 | 4 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | Oral | QD | U | 0 | INJECTION | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113636042 | 11363604 | 1 | Chronic myeloid leukaemia |
| 113636042 | 11363604 | 3 | Pain |
| 113636042 | 11363604 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113636042 | 11363604 | DS |
| 113636042 | 11363604 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113636042 | 11363604 | Anaemia | |
| 113636042 | 11363604 | Chikungunya virus infection | |
| 113636042 | 11363604 | Diarrhoea | |
| 113636042 | 11363604 | Dizziness | |
| 113636042 | 11363604 | Fear | |
| 113636042 | 11363604 | Gene mutation identification test positive | |
| 113636042 | 11363604 | Haematology test abnormal | |
| 113636042 | 11363604 | Infection | |
| 113636042 | 11363604 | Intervertebral disc protrusion | |
| 113636042 | 11363604 | Myalgia | |
| 113636042 | 11363604 | Oedema peripheral | |
| 113636042 | 11363604 | Pyrexia | |
| 113636042 | 11363604 | Spinal pain | |
| 113636042 | 11363604 | Syncope | |
| 113636042 | 11363604 | Tachycardia |
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 |
|---|---|---|---|---|---|---|
| 113636042 | 11363604 | 1 | 20130529 | 0 |