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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 905368410 | 9053684 | 10 | F | 201301 | 20160916 | 20130208 | 20160926 | EXP | PHHY2013CA012245 | NOVARTIS | 38.07 | YR | M | Y | 0.00000 | 20160926 | CN | COUNTRY NOT SPECIFIED | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 905368410 | 9053684 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, BID | 22068 | 300 | MG | CAPSULE | BID | ||||||
| 905368410 | 9053684 | 2 | SS | REACTINE | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | Y | 0 | ||||||||||
| 905368410 | 9053684 | 3 | SS | HYDROXYUREA. | HYDROXYUREA | 1 | Unknown | Y | 0 | ||||||||||
| 905368410 | 9053684 | 4 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | PRN | U | 0 | |||||||||
| 905368410 | 9053684 | 5 | C | EPIPEN | EPINEPHRINE | 1 | Unknown | PRN | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 905368410 | 9053684 | 1 | Chronic myeloid leukaemia |
| 905368410 | 9053684 | 2 | Product used for unknown indication |
| 905368410 | 9053684 | 3 | Product used for unknown indication |
| 905368410 | 9053684 | 4 | Product used for unknown indication |
| 905368410 | 9053684 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 905368410 | 9053684 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 905368410 | 9053684 | Acne | |
| 905368410 | 9053684 | Arthralgia | |
| 905368410 | 9053684 | Blood phosphorus decreased | |
| 905368410 | 9053684 | Blood sodium decreased | |
| 905368410 | 9053684 | Dry skin | |
| 905368410 | 9053684 | Electrocardiogram QT prolonged | |
| 905368410 | 9053684 | Groin pain | |
| 905368410 | 9053684 | Haemoglobin decreased | |
| 905368410 | 9053684 | Hepatic enzyme increased | |
| 905368410 | 9053684 | Nasopharyngitis | |
| 905368410 | 9053684 | Pyrexia | |
| 905368410 | 9053684 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 905368410 | 9053684 | 1 | 20121226 | 0 |