|
Herceptin plus chemotherapy arm, the initial dose of Herceptin 8 mg/kg was administered on Day 1 (prior to chemotherapy) followed by 6 mg/kg every 21 days until disease progression. Cisplatin was administered at 80 mg/m2 on Day 1 and the fluoropyrimidine was administered as either capecitabine 1000 mg/m2 orally twice a day on Days 1-14 or 5-fluorouracil 800 mg/m2/day as a continuous intravenous infusion Days 1 through 5. Chemotherapy was administered for six 21-day cycles. Median duration of Herceptin treatment was 21 weeks; median number of Herceptin infusions administered was eight.
Table 5: Study 7: Per Patient Incidence of Adverse Reactions of All Grades (Incidence ≥ 5% between Arms) or Grade 3 /4 (Incidence >1% between Arms) and Higher Incidence in Herceptin Arm
|
|
Herceptin +FC
(N = 294)
N (%) |
FC
(N = 290)
N (%) |
|
Body System/ Adverse Event |
All Grades |
Grades 3/4 |
All Grades |
Grades 3/4 |
|
Investigations |
|
Neutropenia |
230 (78) |
101 (34) |
212 (73) |
83 (29) |
|
Hypokalemia |
83 (28) |
28 (10) |
69 (24) |
16 (6) |
|
Anemia |
81 (28) |
36 (12) |
61 (21) |
30 (10) |
|
Thrombocytopenia |
47 (16) |
14 (5) |
33 (11) |
8 (3) |
|
Blood And Lymphatic System Disorders |
|
Febrile Neutropenia |
— |
15 ( 5) |
— |
8 (3) |
|
Gastrointestinal Disorders |
|
Diarrhea |
109 (37) |
27 (9) |
80 (28) |
11 (4) |
|
Stomatitis |
72 (24) |
2 (1) |
43 (15) |
6 (2) |
|
Dysphagia |
19 (6) |
7 (2) |
10 (3) |
1 (≤ 1) |
|
Body as a Whole |
|
Fatigue |
102 (35) |
12 (4) |
82 (28) |
7 ( 2) |
|
Fever |
54 (18) |
3 (1) |
36 (12) |
0 (0) |
|
Mucosal Inflammation |
37 (13) |
6 (2) |
18 (6) |
2 (1) |
|
Chills |
23 (8) |
1 (≤ 1) |
0 (0) |
0 (0) |
|
Metabolism And Nutrition Disorders |
|
Weight Decrease |
69 (23) |
6 (2) |
40 (14) |
7 (2) |
|
Infections And Infestations |
|
Upper Respiratory Tract Infections |
56 (19) |
0 (0) |
29 (10) |
0 (0) |
|
Nasopharyngitis |
37 (13) |
0 (0) |
17 (6) |
0 (0) |
|
Renal And Urinary Disorders |
|
Renal Failure and Impairment |
53 (18) |
8 (3) |
42 (15) |
5 (2) |
|
Nervous System Disorders |
|
Dysgeusia |
28 (10) |
0 (0) |
14 (5) |
0 (0) |
The following subsections provide additional detail regarding adver |
