thnic groups. Most of the patients received 4mg/kg initial dose of Herceptin followed by 2mg/kg weekly. The percentages of patients who received Herceptin treatment for ≥ 6 months and ≥ 12months were 31% and 16%, respectively.
Table 4: Per‑Patient Incidence of Adverse Reactions Occurring in≥5% of Patients in Uncontrolled Studies or at Increased Incidence in the Herceptin Arm (Studies 5 and 6)
|
|
Single Agent* n=352 |
Herceptin + Paclitaxel
n=91 |
Paclitaxel Alone
n=95 |
Herceptin + AC†
n=143 |
AC† Alone
n = 135 |
|
Data for Herceptin single agent were from 4studies, including 213patients from Study6.
Anthracycline (doxorubicin or epirubicin) and cyclophosphamide.
|
|
Body as a Whole |
|
|
|
|
|
|
Pain |
47% |
61% |
62% |
57% |
42% |
|
Asthenia |
42% |
62% |
57% |
54% |
55% |
|
Fever |
36% |
49% |
23% |
56% |
34% |
|
Chills |
32% |
41% |
4% |
35% |
11% |
|
Headache |
26% |
36% |
28% |
44% |
31% |
|
Abdominal pain |
22% |
34% |
22% |
23% |
18% |
|
Back pain |
22% |
34% |
30% |
27% |
15% |
|
Infection |
20% |
47% |
27% |
47% |
31% |
|
Flu syndrome |
10% |
12% |
5% |
12% |
6% |
|
Accidental injury |
6% |
13% |
3% |
9% |
4% |
|
Allergic reaction |
3% |
8% |
2% |
4% |
2% |
|
Cardiovascular |
|
|
|
|
|
|
Tachycardia |
5% |
12% |
4% |
10% |
5% |
|
Congestive heart failure |
7% |
11% |
1% |
28% |
7% |
|
Digestive |
|
|
|
|
|
|
Nausea |
33% |
51% |
9% |
76% |
77% |
|
Diarrhea |
25% |
45% |
29% |
45% |
26% |
|
Vomiting |
23% |
37% |
28% |
53% |
49% |
|
Nausea and vomiting |
8% |
14% |
11% |
18% |
9% |
|
Anorexia |
14% |
24% |
16% |
31% |
26% |
|
Heme & Lymphatic |
|
|
|
