TABLE 66Adverse events with nilotinib

CPAPAll phases
All gradesGrade 3–4All gradesGrade 3–4All gradesGrade 3–4
Kantarjian et al.,106 ImR/ImI, 400 mg b.i.d.Expanded access programmeaKantarjian et al.,106 ImR/ImI, 400 mg b.i.d.Expanded access programmeaTojo et al.,108 ImR/ImI, 400 mg b.i.d.le Coutre et al.,107 ImR/ImI, 400 mg b.i.d.Expanded access programmeale Coutre et al.,107 ImR/ImI, 400 mg b.i.d.Expanded access programmeaTojo et al.,108 ImR/ImI, 400 mg b.i.d.Tojo et al.,108 ImR/ImI, 400 mg b.i.d.Kantarjian et al.,103 ImR, Mixed/NRTojo et al.,108 ImR/ImI, 400 mg b.i.d.
n2801217280121716119157119157734b11934b
Haematological AEs
Anaemia (%)3.018.8c12.612.057.1c5.0
Leucopenia (%)31.3d42.9d
Neutropenia (%)28.911.037.5e21.025.071.4e10.9
Thrombopenia (%)28.918.018.8f35.315.042.9f16.8
Non-haematological AEs
Abdominal pain (%)6.70.8
Alopecia (%)18.40.00.0
Anorexia (%)5.90.014.70.0
Arthralgia (%)5.00.0
Back pain (%)11.82.9
Chest pain (%)11.80.0
Constipation (%)12.16.00.0< 1.010.91.00.00.011.80.00.0
Diarrhoea (%)11.42.119.20.8
Dry skin (%)0.0
Eczema (%)14.70.0
Erythema (%)11.80.0
Fatigue (%)18.68.01.1< 1.010.16.00.8< 1.00.8
Headache (%)18.616.01.82.010.111.00.8< 1.032.45.9
Hepatic dysfunction (%)14.70.0
Malaise (%)14.70.0
Muscle spasms (%)19.20.011.80.0
Myalgia (%)8.21.119.20.8
Nausea (%)23.612.01.1< 1.010.114.00.80.032.42.9
Nausea and/or vomiting (%)0.0
Pain in extremity (%)4.60.75.00.0
Peripheral oedema (%)5.00.0
Pruritus (%)23.912.01.1< 1.020.25.00.00.011.81.70.0
Pyrexia (%)18.40.823.50.0
Rash (%)28.224.03.23.021.817.00.02.050.01.72.9
Stomach pain (%)11.80.0
Upper abdominal pain (%)5.00.0
Vomiting (%)10.77.00.7< 1.08.0< 1.029.40.0

NR, not reported.

a

Data extracted from the Novartis submission.205

b

Includes four participants in BC and seven with Ph+ ALL.

c

Specified as grade 3–4 laboratory abnormality (haemoglobin).

d

Specified as grade 3–4 laboratory abnormality (WBC).

e

Specified as grade 3–4 laboratory abnormality (neutrophils).

f

Specified as grade 3–4 laboratory abnormality (platelets).

From: 2, Assessment of clinical effectiveness

Cover of Dasatinib and Nilotinib for Imatinib-Resistant or -Intolerant Chronic Myeloid Leukaemia: A Systematic Review and Economic Evaluation
Dasatinib and Nilotinib for Imatinib-Resistant or -Intolerant Chronic Myeloid Leukaemia: A Systematic Review and Economic Evaluation.
Health Technology Assessment, No. 16.22.
Rogers G, Hoyle M, Thompson Coon J, et al.
Southampton (UK): NIHR Journals Library; 2012 Apr.
© 2012, Crown Copyright.

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