ASH Clinical News Focus on Myeloid Malignancies | Page 30

IMBRUVICA ® (ibrutinib) capsules IMBRUVICA ® (ibrutinib) capsules
Subjects with multiple events for a given ADR term are counted once only
for each ADR term.
The body system and individual ADR terms are sorted in descending
frequency order in the IMBRUVICA arm.
* Includes multiple ADR terms Study 4: Adverse reactions described below in Table 8 reflect exposure
to IMBRUVICA + BR with a median duration of 14.7 months and exposure
to placebo + BR with a median of 12.8 months in Study 4 in patients with
previously treated CLL/SLL.
Table 6: Treatment-Emergent* Decrease of Hemoglobin, Platelets, or
Neutrophils in Patients with CLL/SLL in Study 2
IMBRUVICA
Ofatumumab
(N=195)
(N=191)
All Grades Grade 3 or 4 All Grades Grade 3 or 4
(%)
(%)
(%)
(%)
Neutrophils Decreased
51
23
57
26
Platelets Decreased
52
5
45
10
Hemoglobin Decreased
36
0
21
0
* Based on laboratory measurements per IWCLL criteria.
Study 3: Adverse reactions described below in Table 7 reflect exposure to
IMBRUVICA with a median duration of 17.4 months. The median exposure to
chlorambucil was 7.1 months in Study 3.
Table 7: Adverse Reactions Reported in ≥ 10% of Patients and
at Least 2% Greater in the IMBRUVICA Treated Arm
in Patients with CLL/SLL in Study 3
IMBRUVICA
Chlorambucil
(N=135)
(N=132)
All Grades Grade 3 or 4 All Grades Grade 3 or 4
Body System
(%)
(%)
(%)
(%)
Adverse Reaction
Gastrointestinal
disorders
Diarrhea
42
4
17
0
Stomatitis*
14
1
4
1
Musculoskeletal and
connective tissue
disorders
Musculoskeletal pain*
36
4
20
0
Arthralgia
16
1
7
1
Muscle spasms
11
0
5
0
Eye Disorders
Dry