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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104085795 | 10408579 | 5 | F | 201412 | 20160914 | 20140826 | 20160920 | EXP | PHHY2014CA104619 | NOVARTIS | 57.83 | YR | F | Y | 0.00000 | 20160920 | MD | CA | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104085795 | 10408579 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, BID | 22068 | 300 | MG | CAPSULE | BID | ||||||
| 104085795 | 10408579 | 2 | SS | TASIGNA | NILOTINIB | 1 | Unknown | 600 MG, QD (AT ONCE) | 22068 | 600 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 104085795 | 10408579 | 1 | Chronic myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 104085795 | 10408579 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 104085795 | 10408579 | Conjunctivitis | |
| 104085795 | 10408579 | Diarrhoea | |
| 104085795 | 10408579 | Distractibility | |
| 104085795 | 10408579 | Ear infection | |
| 104085795 | 10408579 | Food interaction | |
| 104085795 | 10408579 | Frequent bowel movements | |
| 104085795 | 10408579 | Fungal infection | |
| 104085795 | 10408579 | Fungal skin infection | |
| 104085795 | 10408579 | Incorrect dose administered | |
| 104085795 | 10408579 | Nail discolouration | |
| 104085795 | 10408579 | Nasopharyngitis | |
| 104085795 | 10408579 | Onychalgia | |
| 104085795 | 10408579 | Onychoclasis | |
| 104085795 | 10408579 | Onychomycosis | |
| 104085795 | 10408579 | Skin disorder |
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 |
|---|---|---|---|---|---|---|
| 104085795 | 10408579 | 1 | 20140127 | 0 |