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Table 7: Percent Incidence of Clinically Relevant Grade 3/4* Laboratory
Abnormalities
Patient Population
Resistant or
Intolerant Ph+
Newly Diagnosed
Ph+ CML-CP
CML-CP
CML-AP
TASIGNA Imatinib
TASIGNA TASIGNA
300 mg
400 mg
400 mg
400 mg
twice-daily once-daily twice-daily twice-daily
N=279
N=280
N=321
N=137
(%)
(%)
(%)
(%)
Biochemistry Parameters
Elevated creatinine
0
<1
<1
<1
*NCI Common Terminology Criteria for Adverse Events, version 3.0
1CML-CP: Thrombocytopenia: 12% were grade 3, 18% were grade 4
2CML-CP: Neutropenia: 16% were grade 3, 15% were grade 4
3CML-AP: Thrombocytopenia: 11% were grade 3, 32% were grade 4
4CML-AP: Neutropenia: 16% were grade 3, 26% were grade 4
Elevated total cholesterol (all grades) occurred in 28% (Tasigna 300 mg bid)
and 4% (imatinib). Elevated triglycerides (all grades) occurred in 12% and
8% of patients in the Tasigna and imatinib arms, respectively. Hyperglycemia
(all grades) occurred in 50% and 31% of patients in the Tasigna and imatinib
arms, respectively.
Most common biochemistry laboratory abnormalities (all grades) were alanine aminotransferase increased (72%), blood bilirubin increased (59%),
aspartate aminotransferase increased (47%), lipase increased (28%), blood
glucose increased (50%), blood cholesterol increased (28%), and blood
triglyceride increased (12%).
6.2 Additional Data from Clinical Trials
The following adverse drug reactions were reported in patients in the
Tasigna clinical studies at the recommended doses. These adverse drug
reactions are ranked under a heading of frequency, the most frequent
first using the following convention: common (≥1% and <10%), uncommon (≥0.1% and <1%), and unknown frequency (single events). For laboratory abnormalities, very common events (≥10%), which were not
included in Tables 5 and 6, are also reported. These adverse reactions
are included based on clinical relevance and ranked in order of decreasing seriousness within each category, obtained from 2 clinical studies:
1. Newly diagnosed Ph+ CML-CP 60 month analysis and,
2. Resistant or intolerant Ph+ CML-CP and CMP-AP 24 months’ analysis.
Infections and Infestations: Common: folliculitis. Uncommon: pneumonia, bronchitis, urinary tract infection, candidiasis (including oral candidiasis). Unknown frequency: sepsis, subcutaneous abscess, anal
abscess, furuncle, tinea pedis.
Neoplasms Benign, Malignant, and Unspecified: Common: skin papilloma. Unknown frequency: oral papilloma, paraproteinemia.
Blood and Lymphatic System Disorders: Common: leukopenia,
eosinophilia, febrile neutropenia, pancytopenia, lymphopenia. Unknown
frequency: thrombocythem