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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 929774018 | 9297740 | 18 | F | 20160814 | 20130520 | 20160819 | EXP | PHHY2013IL049256 | NOVARTIS | 0.00 | M | Y | 84.00000 | KG | 20160819 | MD | IL | IL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 929774018 | 9297740 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 600 MG, QD | Y | 22068 | 600 | MG | CAPSULE | QD | |||||
| 929774018 | 9297740 | 2 | SS | TASIGNA | NILOTINIB | 1 | Oral | 200 MG, BID | Y | 22068 | 200 | MG | CAPSULE | BID | |||||
| 929774018 | 9297740 | 3 | SS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, BID | Y | 22068 | 300 | MG | CAPSULE | BID | |||||
| 929774018 | 9297740 | 4 | SS | TASIGNA | NILOTINIB | 1 | Oral | 500 MG, QD | Y | 22068 | 500 | MG | CAPSULE | QD | |||||
| 929774018 | 9297740 | 5 | SS | TASIGNA | NILOTINIB | 1 | Oral | 400 MG, UNK | Y | 22068 | 400 | MG | CAPSULE | ||||||
| 929774018 | 9297740 | 6 | SS | TASIGNA | NILOTINIB | 1 | Oral | 500 MG, QD | Y | 22068 | 500 | MG | CAPSULE | QD | |||||
| 929774018 | 9297740 | 7 | SS | TASIGNA | NILOTINIB | 1 | Oral | 400 MG, QD | Y | 22068 | 400 | MG | CAPSULE | QD | |||||
| 929774018 | 9297740 | 8 | SS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, BID | Y | 22068 | 300 | MG | CAPSULE | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 929774018 | 9297740 | 1 | Chronic myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 929774018 | 9297740 | HO |
| 929774018 | 9297740 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 929774018 | 9297740 | Abdominal pain | |
| 929774018 | 9297740 | Acne | |
| 929774018 | 9297740 | Anaemia | |
| 929774018 | 9297740 | Asthenia | |
| 929774018 | 9297740 | Back pain | |
| 929774018 | 9297740 | Basal cell carcinoma | |
| 929774018 | 9297740 | Blood immunoglobulin G increased | |
| 929774018 | 9297740 | Bone marrow disorder | |
| 929774018 | 9297740 | Erythema | |
| 929774018 | 9297740 | Fatigue | |
| 929774018 | 9297740 | Fracture | |
| 929774018 | 9297740 | Light chain analysis increased | |
| 929774018 | 9297740 | Limb injury | |
| 929774018 | 9297740 | Melanocytic naevus | |
| 929774018 | 9297740 | Muscle spasms | |
| 929774018 | 9297740 | Myalgia | |
| 929774018 | 9297740 | Neck pain | |
| 929774018 | 9297740 | Pelvic pain | |
| 929774018 | 9297740 | Plasma cell myeloma | |
| 929774018 | 9297740 | Pruritus | |
| 929774018 | 9297740 | Rash | |
| 929774018 | 9297740 | Rash pruritic | |
| 929774018 | 9297740 | Second primary malignancy | |
| 929774018 | 9297740 | Skin lesion | |
| 929774018 | 9297740 | Skin ulcer | |
| 929774018 | 9297740 | Tumour marker increased | |
| 929774018 | 9297740 | Wound |
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 |
|---|---|---|---|---|---|---|
| 929774018 | 9297740 | 3 | 20110401 | 0 | ||
| 929774018 | 9297740 | 4 | 20130901 | 0 |