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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125265652 | 12526565 | 2 | F | 20160612 | 20160715 | 20160705 | 20160719 | EXP | PHHO2016DE009320 | NOVARTIS | 79.00 | YR | M | Y | 63.00000 | KG | 20160719 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125265652 | 12526565 | 1 | PS | AMN107 | NILOTINIB | 1 | Oral | 450 MG, BID | 369000 | MG | 22068 | 450 | MG | CAPSULE | BID | ||||
| 125265652 | 12526565 | 2 | SS | AMN107 | NILOTINIB | 1 | Oral | 450 MG, QD | 369000 | MG | 22068 | 450 | MG | CAPSULE | QD | ||||
| 125265652 | 12526565 | 3 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | 30 UG, EVERY 10 DAYS | 0 | 30 | UG | INJECTION | |||||||
| 125265652 | 12526565 | 4 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | 30 UG, EVERY 10 DAYS | 0 | 30 | UG | INJECTION | |||||||
| 125265652 | 12526565 | 5 | C | FLUVASTATIN | FLUVASTATIN SODIUM | 1 | Unknown | 80 MG, QD | 0 | 80 | MG | QD | |||||||
| 125265652 | 12526565 | 6 | C | HCT | HYDROCHLOROTHIAZIDE | 1 | Unknown | 12.5 MG, QD | 0 | 12.5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125265652 | 12526565 | 1 | Chronic myeloid leukaemia |
| 125265652 | 12526565 | 3 | Chronic myeloid leukaemia |
| 125265652 | 12526565 | 5 | Hyperlipidaemia |
| 125265652 | 12526565 | 6 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125265652 | 12526565 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125265652 | 12526565 | Myocardial infarction |
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 |
|---|---|---|---|---|---|---|
| 125265652 | 12526565 | 1 | 20150430 | 20160612 | 0 | |
| 125265652 | 12526565 | 2 | 20160621 | 0 | ||
| 125265652 | 12526565 | 3 | 20151128 | 20160607 | 0 | |
| 125265652 | 12526565 | 4 | 20160621 | 0 | ||
| 125265652 | 12526565 | 5 | 2005 | 0 |