Diarrhea |
48 |
4 |
18 |
2 |
Nausea |
26 |
2 |
18 |
0 |
Stomatitis * |
17 |
1 |
6 |
1 |
Constipation |
15 |
0 |
9 |
0 |
Vomiting |
14 |
0 |
6 |
1 |
General disorders and administration site conditions
Pyrexia
|
24 |
2 |
15 |
1 |
Infections and infestations Upper respiratory tract |
16 |
1 |
11 |
2 |
infection |
||||
Pneumonia * |
15 |
10 |
13 |
9 |
Sinusitis * |
11 |
1 |
6 |
0 |
Urinary tract infection |
10 |
4 |
5 |
1 |
Skin and subcutaneous tissue disorders
Rash *
|
24 |
3 |
13 |
0 |
Petechiae |
14 |
0 |
1 |
0 |
Bruising * |
12 |
0 |
1 |
0 |
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain *
|
28 |
2 |
18 |
1 |
Arthralgia |
17 |
1 |
7 |
0 |
Nervous system disorders Headache |
14 |
1 |
6 |
0 |
Dizziness |
11 |
0 |
5 |
0 |
Injury , poisoning and procedural complications
Contusion
|
11 |
0 |
3 |
0 |
Eye disorders Vision blurred |
10 |
0 |
3 |
0 |
Subjects with multiple events for a given ADR term are counted once only for each ADR term . | ||||
The system organ class and individual ADR terms are sorted in descending frequency order in the | ||||
IMBRUVICA arm . | ||||
* Includes multiple ADR terms |
Table 6 : Treatment-Emergent * Decrease of Hemoglobin , Platelets , or Neutrophils in Study 2 | ||||
IMBRUVICA ( N = 195 ) |
Ofatumumab ( 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 in Study 3 | ||||
IMBRUVICA ( N = 135 ) |
Chlorambucil ( N = 132 ) |
|||
Body System Adverse Reaction |
All Grades (%) |
Grade 3 or 4 (%) |
All Grades (%) |
Grade 3 or 4 (%) |
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 eye |
17 |
0 |
5 |
0 |
Lacrimation increased |
13 |
0 |
6 |
0 |
Vision blurred |
13 |
0 |
8 |
0 |
Visual acuity reduced |
11 |
0 |
2 |
0 |
Table 7 : Adverse Reactions Reported in ≥ 10 % of Patients and at Least 2 % Greater | ||||
in the IMBRUVICA Treated Arm in Patients in Study 3 ( continued ) | ||||
IMBRUVICA ( N = 135 ) |
Chlorambucil ( N = 132 ) |
|||
Body System Adverse Reaction |
All Grades (%) |
Grade 3 or 4 (%) |
All Grades (%) |
Grade 3 or 4 (%) |
Skin and subcutaneous tissue disorders
Rash *
|
21 |
4 |
12 |
2 |
Bruising * |
19 |
0 |
7 |
0 |
Infections and infestations Skin infection * |
15 |
2 |
3 |
1 |
Pneumonia * |
14 |
8 |
7 |
4 |
Urinary tract infections |
10 |
1 |
8 |
1 |
Respiratory , thoracic and mediastinal disorders
Cough
|
22 |
0 |
15 |
0 |
General disorders and administration site conditions
Peripheral edema
|
19 |
1 |
9 |
0 |
Pyrexia |
17 |
0 |
14 |
2 |
Vascular Disorders Hypertension * |
14 |
4 |
1 |
0 |
Nervous System Disorders Headache |
12 |
1 |
10 |
2 |
Subjects with multiple events for a given ADR term are counted once only for each ADR term . | ||||
The system organ class and individual ADR terms are sorted in descending frequency order in the | ||||
IMBRUVICA arm . | ||||
* Includes multiple ADR terms |
Neutropenia * |
66 |
61 |
60 |
55 |
Thrombocytopenia * |
34 |
16 |
26 |
16 |
Skin and subcutaneous tissue disorders
Rash *
|
32 |
4 |
25 |
1 |
Bruising * |
20 |
< 1 |
8 |
< 1 |
Gastrointestinal disorders Diarrhea |
36 |
2 |
23 |
1 |
Abdominal Pain |
12 |
1 |
8 |
< 1 |
Musculoskeletal and connective tissue disorders
Musculoskeletal pain *
|
29 |
2 |
20 |
0 |
Muscle spasms |
12 |
< 1 |
5 |
0 |
General disorders and administration site conditions
Pyrexia
|
25 |
4 |
22 |
2 |
Vascular Disorders Hemorrhage * |
19 |
2 |
9 |
1 |
Hypertension * |
11 |
5 |
5 |
2 |
Infections and infestations Bronchitis |
13 |
2 |
10 |
3 |
Skin infection * |
10 |
3 |
6 |
2 |
Metabolism and nutrition disorders
Hyperuricemia
|
10 |
2 |
6 |
0 |
The system organ class and individual ADR terms are sorted in descending frequency order in the | ||||
IMBRUVICA arm . | ||||
* Includes multiple ADR terms | ||||
< 1 used for frequency above 0 and below 0.5 % |