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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121041314 | 12104131 | 4 | F | 20151216 | 20160907 | 20160223 | 20160913 | EXP | PHHY2015IQ120176 | NOVARTIS | 0.00 | A | M | Y | 0.00000 | 20160913 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121041314 | 12104131 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 800 MG, QD | U | 22068 | 800 | MG | CAPSULE | QD | |||||
| 121041314 | 12104131 | 2 | C | POSTAN | 2 | Oral | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121041314 | 12104131 | 1 | Chronic myeloid leukaemia |
| 121041314 | 12104131 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121041314 | 12104131 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121041314 | 12104131 | Abdominal distension | |
| 121041314 | 12104131 | Anxiety | |
| 121041314 | 12104131 | Arthralgia | |
| 121041314 | 12104131 | Cough | |
| 121041314 | 12104131 | Decreased appetite | |
| 121041314 | 12104131 | Dyspnoea | |
| 121041314 | 12104131 | Fatigue | |
| 121041314 | 12104131 | Granuloma skin | |
| 121041314 | 12104131 | Headache | |
| 121041314 | 12104131 | Influenza | |
| 121041314 | 12104131 | Lung infection | |
| 121041314 | 12104131 | Pulmonary fibrosis | |
| 121041314 | 12104131 | Rash | |
| 121041314 | 12104131 | Weight decreased | |
| 121041314 | 12104131 | 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 |
|---|---|---|---|---|---|---|
| 121041314 | 12104131 | 1 | 2013 | 0 |