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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126505361 | 12650536 | 1 | I | 20140627 | 20160815 | 20160815 | PER | PHEH2014US013086 | NOVARTIS | 0.00 | F | Y | 0.00000 | 20160815 | MD | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126505361 | 12650536 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, BID | U | F0025 | 22068 | 300 | MG | CAPSULE | BID | ||||
| 126505361 | 12650536 | 2 | SS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG/KG BID | U | FOO60A | 22068 | 300 | MG | CAPSULE | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126505361 | 12650536 | 1 | Chronic myeloid leukaemia |
| 126505361 | 12650536 | 2 | Leukocytosis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126505361 | 12650536 | Arthralgia | |
| 126505361 | 12650536 | Dermatitis acneiform | |
| 126505361 | 12650536 | Headache | |
| 126505361 | 12650536 | Miliaria | |
| 126505361 | 12650536 | Muscular weakness | |
| 126505361 | 12650536 | Pain | |
| 126505361 | 12650536 | Pain in extremity | |
| 126505361 | 12650536 | Pruritus |
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 |
|---|---|---|---|---|---|---|
| 126505361 | 12650536 | 1 | 201006 | 0 | ||
| 126505361 | 12650536 | 2 | 20140616 | 0 |