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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125512391 | 12551239 | 1 | I | 20150301 | 20160707 | 20160713 | 20160713 | PER | PHEH2016US016961 | NOVARTIS | 67.28 | YR | F | Y | 0.00000 | 20160713 | CN | COUNTRY NOT SPECIFIED | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125512391 | 12551239 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 150 MG, BID (1 IN AM AND 1 IN PM) | 22068 | 150 | MG | CAPSULE | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125512391 | 12551239 | 1 | Chronic myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125512391 | 12551239 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125512391 | 12551239 | Diarrhoea | |
| 125512391 | 12551239 | Pancreatitis | |
| 125512391 | 12551239 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125512391 | 12551239 | 1 | 201502 | 0 |