|
d with controls. |
|
2 Adverse events were graded using the NCI CTC, V 2.0. |
|
3 Infusion reaction is defined as any event (chills, rigors, dyspnea, tachycardia, bronchospasm, chest tightness, swelling, urticaria, hypotension, flushing, rash, hypertension, nausea, angioedema, pain, pruritus, sweating, tremors, shaking, cough, visual disturbances, or other) recorded by the investigator as infusion-related. |
|
BSC = best supportive care |
|
Dermatology |
|
|
|
|
|
Rash/Desquamation |
89 |
12 |
16 |
<1 |
|
Dry Skin |
49 |
0 |
11 |
0 |
|
Pruritus |
40 |
2 |
8 |
0 |
|
Other-Dermatology |
27 |
1 |
6 |
1 |
|
Nail Changes |
21 |
0 |
4 |
0 |
|
Body as a Whole |
|
|
|
|
|
Fatigue |
89 |
33 |
76 |
26 |
|
Fever |
30 |
1 |
18 |
<1 |
|
Infusion Reactions3 |
20 |
5 |
|
|
|
Rigors, Chills |
13 |
<1 |
4 |
0 |
|
Pain |
|
|
|
|
|
Abdominal Pain |
59 |
14 |
52 |
16 |
|
Pain-Other |
51 |
16 |
34 |
7 |
|
Headache |
33 |
4 |
11 |
0 |
|
Bone Pain |
15 |
3 |
7 |
2 |
|
Pulmonary |
|
|
|
|
|
Dyspnea |
48 |
16 |
43 |
12 |
|
Cough |
29 |
2 |
19 |
1 |
|
Gastrointestinal |
|
|
|
|
|
Constipation |
46 |
4 |
38 |
5 |
|
Diarrhea |
39 |
2 |
20 |
2 |
|
Vomiting |
37 |
6 |
29 |
6 |
|
Stomatitis |
25 |
1 |
10 |
<1 |
|
Other-Gastrointestinal |
23 |
10 |
18 |
8 |
|
Mouth Dryness |
11 |
0 |
4 |
0 |
|
Infection |
|
|
|
|
|
Infection without neutropenia |
35 |
13 |
17 |
6 |
|
Neurology |
|
|
|
|
|
Insomnia |
30 |
1 |
15 |
|
