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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109201073 | 10920107 | 3 | F | 201412 | 20160822 | 20150317 | 20160826 | EXP | PHJP2015JP002814 | NOVARTIS | 60.00 | YR | M | Y | 0.00000 | 20160826 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109201073 | 10920107 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 800 MG, QD | 22068 | 800 | MG | CAPSULE | QD | ||||||
| 109201073 | 10920107 | 2 | SS | TASIGNA | NILOTINIB | 1 | Oral | UNK | 22068 | CAPSULE | |||||||||
| 109201073 | 10920107 | 3 | C | GLIVEC | IMATINIB MESYLATE | 1 | Oral | 400 MG, UNK | Y | 0 | 400 | MG | |||||||
| 109201073 | 10920107 | 4 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Oral | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109201073 | 10920107 | 1 | Chronic myeloid leukaemia |
| 109201073 | 10920107 | 3 | Product used for unknown indication |
| 109201073 | 10920107 | 4 | Hypercholesterolaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109201073 | 10920107 | OT |
| 109201073 | 10920107 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109201073 | 10920107 | Extremity necrosis | |
| 109201073 | 10920107 | Pain in extremity | |
| 109201073 | 10920107 | Peripheral arterial occlusive disease | |
| 109201073 | 10920107 | Vasculitis |
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 |
|---|---|---|---|---|---|---|
| 109201073 | 10920107 | 1 | 200912 | 201501 | 0 | |
| 109201073 | 10920107 | 2 | 20150302 | 0 | ||
| 109201073 | 10920107 | 3 | 200912 | 0 |