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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1059739610 | 10597396 | 10 | F | 20141019 | 20160629 | 20141121 | 20160706 | EXP | PHHY2014IL138880 | NOVARTIS | 78.80 | YR | M | Y | 92.00000 | KG | 20160706 | CN | COUNTRY NOT SPECIFIED | IL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1059739610 | 10597396 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 400 MG, BID | Y | 22068 | 400 | MG | CAPSULE | BID | |||||
| 1059739610 | 10597396 | 2 | SS | TASIGNA | NILOTINIB | 1 | Oral | 200 MG, BID | Y | SO102, S0110A, S0127 | 22068 | 200 | MG | CAPSULE | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1059739610 | 10597396 | 1 | Chronic myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1059739610 | 10597396 | HO |
| 1059739610 | 10597396 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1059739610 | 10597396 | Abdominal pain | |
| 1059739610 | 10597396 | Abdominal pain upper | |
| 1059739610 | 10597396 | Angina pectoris | |
| 1059739610 | 10597396 | Cardiac disorder | |
| 1059739610 | 10597396 | Chest discomfort | |
| 1059739610 | 10597396 | Drug intolerance | |
| 1059739610 | 10597396 | Electrocardiogram QT prolonged | |
| 1059739610 | 10597396 | Gastric ulcer | |
| 1059739610 | 10597396 | Headache | |
| 1059739610 | 10597396 | Pulmonary oedema | |
| 1059739610 | 10597396 | Underdose |
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 |
|---|---|---|---|---|---|---|
| 1059739610 | 10597396 | 1 | 20141008 | 20141023 | 0 | |
| 1059739610 | 10597396 | 2 | 20141211 | 0 |