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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126134363 | 12613436 | 3 | F | 201609 | 20160919 | 20160802 | 20160926 | EXP | PHHY2016IQ041045 | NOVARTIS | 38.59 | YR | F | Y | 0.00000 | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126134363 | 12613436 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 800 MG, QD | U | 22068 | 800 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126134363 | 12613436 | 1 | Chronic myeloid leukaemia |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126134363 | 12613436 | Abdominal distension | |
| 126134363 | 12613436 | Abdominal pain | |
| 126134363 | 12613436 | Alopecia | |
| 126134363 | 12613436 | Anaemia | |
| 126134363 | 12613436 | Arthralgia | |
| 126134363 | 12613436 | Bone pain | |
| 126134363 | 12613436 | Constipation | |
| 126134363 | 12613436 | Dizziness | |
| 126134363 | 12613436 | Dry skin | |
| 126134363 | 12613436 | Dyspepsia | |
| 126134363 | 12613436 | Fatigue | |
| 126134363 | 12613436 | Granuloma skin | |
| 126134363 | 12613436 | Headache | |
| 126134363 | 12613436 | Hypotension | |
| 126134363 | 12613436 | Incorrect drug administration duration | |
| 126134363 | 12613436 | Insomnia | |
| 126134363 | 12613436 | Menstrual disorder | |
| 126134363 | 12613436 | Menstruation delayed | |
| 126134363 | 12613436 | Nausea | |
| 126134363 | 12613436 | Ovarian cyst | |
| 126134363 | 12613436 | Skin disorder | |
| 126134363 | 12613436 | 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 |
|---|---|---|---|---|---|---|
| 126134363 | 12613436 | 1 | 20160323 | 0 |