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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126837843 | 12683784 | 3 | F | 20160615 | 20160912 | 20160825 | 20160916 | EXP | PHHY2016EC116077 | NOVARTIS | 67.90 | YR | M | Y | 0.00000 | 20160916 | CN | COUNTRY NOT SPECIFIED | EC |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126837843 | 12683784 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 200 MG, BID | 30800 | MG | 22068 | 200 | MG | CAPSULE | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126837843 | 12683784 | 1 | Chronic myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126837843 | 12683784 | HO |
| 126837843 | 12683784 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126837843 | 12683784 | Abdominal distension | |
| 126837843 | 12683784 | Abdominal pain | |
| 126837843 | 12683784 | Abdominal pain upper | |
| 126837843 | 12683784 | Blood pressure decreased | |
| 126837843 | 12683784 | Blood pressure increased | |
| 126837843 | 12683784 | Cardiac arrest | |
| 126837843 | 12683784 | Chronic myeloid leukaemia | |
| 126837843 | 12683784 | Discomfort | |
| 126837843 | 12683784 | Dyspnoea | |
| 126837843 | 12683784 | Headache | |
| 126837843 | 12683784 | Malaise | |
| 126837843 | 12683784 | Nausea | |
| 126837843 | 12683784 | Pyrexia | |
| 126837843 | 12683784 | Rash macular | |
| 126837843 | 12683784 | Spleen disorder |
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 |
|---|---|---|---|---|---|---|
| 126837843 | 12683784 | 1 | 20160608 | 20160823 | 0 |