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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125410762 | 12541076 | 2 | F | 20160627 | 20160906 | 20160708 | 20160914 | PER | PHEH2016US016851 | NOVARTIS | 45.65 | YR | M | Y | 0.00000 | 20160914 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125410762 | 12541076 | 1 | PS | TASIGNA | NILOTINIB | 1 | Unknown | 2 DF, BID (2 CAPS 2X/DAY FOR TWO WEEKS) | U | 0056 | 22068 | 2 | DF | CAPSULE | BID | ||||
| 125410762 | 12541076 | 2 | SS | TASIGNA | NILOTINIB | 1 | Unknown | 300 MG, BID | U | 22068 | 300 | MG | CAPSULE | BID | |||||
| 125410762 | 12541076 | 3 | C | LEVOMET | 2 | Unknown | 34 OT, BID | U | 0 | BID | |||||||||
| 125410762 | 12541076 | 4 | C | INSULIN | INSULIN NOS | 1 | Unknown | U | 0 | ||||||||||
| 125410762 | 12541076 | 5 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 1000 MG, QD | U | 0 | 1000 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125410762 | 12541076 | 1 | Chronic myeloid leukaemia |
| 125410762 | 12541076 | 3 | Diabetes mellitus |
| 125410762 | 12541076 | 4 | Product used for unknown indication |
| 125410762 | 12541076 | 5 | Diabetes mellitus |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125410762 | 12541076 | Blister | |
| 125410762 | 12541076 | Diarrhoea | |
| 125410762 | 12541076 | Pain | |
| 125410762 | 12541076 | Rash generalised |
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 |
|---|---|---|---|---|---|---|
| 125410762 | 12541076 | 2 | 20140625 | 0 | ||
| 125410762 | 12541076 | 3 | 201312 | 0 | ||
| 125410762 | 12541076 | 5 | 201504 | 0 |