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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125310783 | 12531078 | 3 | F | 20160816 | 20160706 | 20160822 | EXP | PHHY2016CO091769 | NOVARTIS | 0.00 | F | Y | 0.00000 | 20160822 | CN | COUNTRY NOT SPECIFIED | CO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125310783 | 12531078 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 200 MG, QID | U | 22068 | 200 | MG | CAPSULE | QID | |||||
| 125310783 | 12531078 | 2 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Unknown | U | 0 | ||||||||||
| 125310783 | 12531078 | 3 | C | HYDROXYUREA. | HYDROXYUREA | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125310783 | 12531078 | 1 | Chronic myeloid leukaemia |
| 125310783 | 12531078 | 2 | Product used for unknown indication |
| 125310783 | 12531078 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125310783 | 12531078 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125310783 | 12531078 | General physical health deterioration | |
| 125310783 | 12531078 | Headache | |
| 125310783 | 12531078 | Hepatitis | |
| 125310783 | 12531078 | Hypersensitivity | |
| 125310783 | 12531078 | Incorrect drug administration duration | |
| 125310783 | 12531078 | Pain | |
| 125310783 | 12531078 | Pyrexia | |
| 125310783 | 12531078 | Splenitis | |
| 125310783 | 12531078 | White blood cell count increased |
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 |
|---|---|---|---|---|---|---|
| 125310783 | 12531078 | 1 | 20140615 | 0 |