ical trials are conducted under widely varying conditions, adverse reaction rates observedin the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug andmay not reflect the rates observed in practice.
Adjuvant Breast Cancer Studies
The data below reflect exposure to one-year trastuzumab therapy across three randomized, open-labelstudies, Studies 1, 2, and 3, with (n = 3678) or without (n = 3363) trastuzumab in the adjuvant treatment ofbreast cancer.
The data summarized in Table 3 below, from Study 3, reflect exposure to trastuzumab in 1678 patients; themedian treatment duration was 51 weeks and median number of infusions was 18. Among the 3386 patientsenrolled in the observation and one-year trastuzumab arms of Study 3 at a median duration of follow-up of12.6 months in the trastuzumab arm, the median age was 49 years (range: 21 to 80 years), 83% of patientswere Caucasian, and 13% were Asian.
Table 3
Adverse Reactions for Study 3a
, All Gradesb
One Year
Trastuzumab
Adverse Reaction (n = 1678)
Observation
(n = 1708)
Cardiac
Hypertension 64 (4%)
Dizziness 60 (4%)
Ejection Fraction Decreased 58 (3.5%)
Palpitations 48 (3%)
Cardiac Arrhythmiasc 40 (3%)
Cardiac Failure Congestive 30 (2%)
Cardiac Failure 9 (0.5%)
Cardiac Disorder 5 (0.3%)
Ventricular Dysfunction 4 (0.2%)
Respiratory Thoracic Mediastinal Disorders
Cough 81 (5%)
Influenza 70 (4%)
Dyspnea 57 (3%)
URI 46 (3%)
Rhinitis 36 (2%)
Pharyngolaryngeal Pain 32 (2%)
Sinusitis 26 (2%)
Epistaxis 25 (2%)
Pulmonary Hypertension 4 (0.2%)
Interstitial Pneumonitis 4 (0.2%)
Gastrointestinal Disorders
Diarrhea 123 (7%)
Nausea 108 (6%)
Vomiting 58 (3.5%)
Constipation 33 (2%)
Dyspepsia 30 (2%)
Upper Abdominal Pain 29 (2%)
Musculoskeletal & Connective Tissue Disorders
Arthralgia 137 (8%)
Back Pain 91 (5%)
Myalgia 63 (4%)
Bone Pain 49 (3%)
Muscle Spasm 46 (3%)
Nervous System Disorders
Headache 162 (10%)
Paraesthesia 29 (2%)
Skin & Subcutaneous Tissue Disorders
Rash 70 (4%)
Nail Disorders 43 (2%)
Pruritus 40 (2%)
35 (2%)
29 (2%)
11 (0.6%)
12 (0.7%)
17 (1%)
5 (0.3%)
4 (0.2%)
0 (0%)
0 (0%)
34 (2%)
9 (0.5%)
26 (2%)
20 (1%)
6 (0.4%)
8 (0.5%)
5 (0.3%)
1 (0.06%)
0 (0%)
0 (0%)
16 (1%)
19 (1%)
10 (0.6%)
17 (1%)
9 (0.5%)
15 (1%)
98 (6%)
58 (3%)
17 (1%)
26 (2%)
3 (0.2%)
49 (3%)
11 (0.6%)
10 (0.6%)
0 (0%)
10 (0.6%)
Table 3 (cont’d)
Adverse Reactions for Study 3a
, All Gradesb
Adverse Reaction
One Year
Trastuzumab
(n = 1678)
Observation
(n = 1708)
General Disorders
Pyrexia
Edema Peripheral
Chills
Asthenia
Influenza-like Illness
Sudden Death
Infections
Nasopharyngitis
UTI
Immune System Disorders
Hypersensitivity
Autoimmune Thyroiditis
100 (6%)
79 (5%)
85 (5%)
75 (4.5%)
40 (2%)
1 (0.06%)
135 (8%)
39 (3%)
10 (0.6%)
4 (0.3%)
6 (0.4%)
37 (2%)
0 (0%)
30 (2%)
3 (0.2%)
0 (0%)
43 (3%)
13 (0.8%)
1 (0.06%)
0 (0%) a Median follow-up duration of 12.6 months in the one-year
trastuzumab treatment arm.
b The incidence of Grade 3 or higher adverse reactions was <1% inboth arms for each listed term c Higher level grouping termIn Study 3, a comparison of 3-weekly trastuzumab treatment for two years ve |
