hs in the AC‑T arm, 24 months in the AC‑TH arm. In Studies 1 and 2, 6% of patients were not permitted to initiate Herceptin following completion of AC chemotherapy due to cardiac dysfunction (LVEF < 50% or ≥ 15 point decline in LVEF from baseline to end of AC). Following initiation of Herceptin therapy, the incidence of new‑onset dose‑limiting myocardial dysfunction was higher among patients receiving Herceptin and paclitaxel as compared to those receiving paclitaxel alone in Studies 1 and 2, and in patients receiving Herceptin monotherapy compared to observation in Study 3 (see Table 6, Figures 1 and 2).
Table 3: Adverse Reactions for Study 3, All GradesThe incidence of Grade 3/4 adverse reactions was <1% in both arms for each listed term.:
|
Adverse Reaction |
(n=1678) |
(n=1708) |
Cardiac |
|
|
|
Hypertension |
64 (4%) |
35 (2%) |
|
Dizziness |
60 (4%) |
29 (2%) |
|
Ejection Fraction Decreased |
58 (3.5%) |
11 (0.6%) |
|
Palpitations |
48 (3%) |
12 (0.7%) |
|
Cardiac ArrhythmiasHigher level grouping term. |
40 (3%) |
17 (1%) |
|
Cardiac Failure Congestive |
30 (2%) |
5 (0.3%) |
|
Cardiac Failure |
9 (0.5%) |
4 (0.2%) |
|
Cardiac Disorder |
5 (0.3%) |
0 (0%) |
|
Ventricular Dysfunction |
4 (0.2%) |
0 (0%) |
Respiratory Thoracic Mediastinal Disorders |
|
Cough |
81 (5%) |
34 (2%) |
|
Influenza |
70 (4%) |
9 (0.5%) |
|
Dyspnea |
57 (3%) |
26 (2%) |
|
URI |
46 (3%) |
20 (1%) |
|
Rhinitis |
36 (2%) |
6 (0.4%) |
|
Pharyngolaryngeal Pain |
32 (2%) |
8 (0.5%) |
|
Sinusitis |
26 (2%) |
5 (0.3%) |
|
Epistaxis |
25 (2%) |
1 (0.06%) |
|
Pulmonary Hypertension |
4 (0.2%) |
0 (0%) |
|
Interstitial Pneumonitis |
4 (0.2%) |
0 (0%) |
Gastrointestinal Disorders |
|
Diarrhea |
123 (7%) |
16 (1%) |
|
Nausea |
108 (6%) |
19 (1%) |
|
Vomiting |
58 (3.5%) |
10 (0.6%) |
|
Constipation |
33 (2%) |
17 (1%) |
|
Dyspepsia |
30 (2%) |
9 (0.5%) |
|
Upper Abdominal Pain |
29 (2%) |
15 (1%) |
Musculoskeletal & Connective Tissue Disorders |
|
Arthralgia |
137 (8%) |
98 (6%) |
|
Back Pain |
91 (5%) |
58 (3%) |
|
Myalgia |
63 (4%) |
17 (1%) |
|
Bone Pain |
49 (3%) |
26 (2%) |
|
Muscle Spasm |
46 (3%) |
3 |
|
