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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1080404513 | 10804045 | 13 | F | 201408 | 20160920 | 20150217 | 20160927 | EXP | PHHY2014IQ125732 | NOVARTIS | 48.00 | YR | F | Y | 0.00000 | 20160927 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1080404513 | 10804045 | 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 |
|---|---|---|---|
| 1080404513 | 10804045 | 1 | Chronic myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1080404513 | 10804045 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1080404513 | 10804045 | Abdominal distension | |
| 1080404513 | 10804045 | Arthralgia | |
| 1080404513 | 10804045 | Back pain | |
| 1080404513 | 10804045 | Chest pain | |
| 1080404513 | 10804045 | Dizziness | |
| 1080404513 | 10804045 | Fall | |
| 1080404513 | 10804045 | Fatigue | |
| 1080404513 | 10804045 | Granuloma skin | |
| 1080404513 | 10804045 | Headache | |
| 1080404513 | 10804045 | Hyperglycaemia | |
| 1080404513 | 10804045 | Hypersensitivity | |
| 1080404513 | 10804045 | Hypertension | |
| 1080404513 | 10804045 | Hypotension | |
| 1080404513 | 10804045 | Incorrect drug administration duration | |
| 1080404513 | 10804045 | Influenza | |
| 1080404513 | 10804045 | Menstrual disorder | |
| 1080404513 | 10804045 | Menstruation irregular | |
| 1080404513 | 10804045 | Metrorrhagia | |
| 1080404513 | 10804045 | Muscle spasms | |
| 1080404513 | 10804045 | Pain in extremity | |
| 1080404513 | 10804045 | Rash | |
| 1080404513 | 10804045 | Upper limb fracture | |
| 1080404513 | 10804045 | Vaginal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 1080404513 | 10804045 | 1 | 20140827 | 0 |