3.9
0
2.3
0
Gastrointestinal Disorders
Dyspepsia
9.2
0
11.5
0.4
Stomatitis
14.1
0.2
32.6
2.5
Dry Mouth
16.7
0
4.9
0.2
Abdominal pain
18.6
0.8
17.6
1.6
Vomiting
19.2
0.8
29.9
4.5
Diarrhea
24.1
1.6
79.7
20.7
Constipation
26.5
0.4
11.1
0
Nausea
39.8
0.8
45.1
2.5
General Disorders and Administration
Peripheral edema
7.1
0
8.2
0.2
Chills
7.6
0
3.1
0
Pyrexia
18.6
0.2
8.4
0.4
Asthenia
17.8
0.4
17.6
1.6
Fatigue
36.3
2.5
28.3
3.5
Hepatobiliary Disorders
Nodular regenerative hyperplasia*
0.4
ND
0
0
Portal hypertension*
0.4
0.2
0
0
Immune System Disorders
Drug hypersensitivity
2.2
0
0.8
0
Injury, Poisoning, and Procedural
Infusion-related reaction
1.4
0
0.2
0
Infections and Infestations
Urinary tract infection
9.4
0.6
3.9
0
Investigations
Blood alkaline phosphatase increased
4.7
0.4
3.7
0.4
Increased transaminases
28.8
8.0
14.3
2.5
Metabolism and Nutrition Disorders
Hypokalemia
10.2
2.7
9.4
4.7
Musculoskeletal and Connective Tissue Disorders
Myalgia
14.1
0.6
3.7
0
Arthralgia
19.2
0.6
8.4
0
Musculoskeletal pain
36.1
1.8
30.5
1.4
Nervous System Disorders
Dysgeusia
8.0
0
4.1
0.2
Dizziness
10.2
0.4
10.7
0.2
Peripheral neuropathy
21.2
2.2
13.5
0.2
Headache
28.2
0.8
14.5
0.8
Psychiatric Disorders
Insomnia
12.0
0.4
8.6
0.2
Respiratory, Thoracic, and Mediastinal Disorders
Pneumonitis
1.2
0
0
0
Dyspnea
12.0
0.8
8.0
0.4
Cough
18.2
0.2
13.1
0.2
Epistaxis
22.5
0.2
8.4
0
Skin and Subcutaneous Tissue Disorders
Pruritus
5.5
0.2
9.2
0
Rash
11.6
0
27.5
1.8
Vascular Disorders
Hypertension
5.1
1.2
2.3
0.4
Table 7 Selected Laboratory Abnormalities
Parameter
KADCYLA
(3.6 mg/kg)
Lapatinib (1250 mg) + Capecitabine (2000 mg/m2)
All Grade %
Grade 3 %
Grade 4 %
All Grade %
Grade 3 %
Grade 4 %
Increased bilirubin
17
<1
0
57
2
0
Increased AST
98
7
<1
65
3
0
Increased ALT
82
5
<1
54
3
0
Decreased platelet count
83
14
3
21
<1
<1
Decreased hemoglobin
60
4
1
64
3
<1
Decreased neutrophils
39
3
<1
38
6
2
Decreased potassium
33
3
0
31
6
<1
6.2 Immunogenicity
As with all therapeutic proteins, there is the potential for an i
