ofiles of the two drugs.
Adverse reactions were analyzed irrespective of whether a symptom was present or absent at baseline. Most adverse reactions reported (approximately 75% of patients reporting 1 or more AE) were Grade 1 or Grade 2 applying the Common Toxicity Criteria Version 2.0/ Common Terminology Criteria for Adverse Events, version 3.0. Table 1 describes adverse reactions (Grades 1-4) irrespective of relationship to study treatment in the adjuvant trial for the monotherapy arms analysis (safety population).
Table 1: Patients with Adverse Reactions (CTC Grades 1-4, Irrespective of Relationship to Study Drug) in the Adjuvant Study – Monotherapy Arms Analysis (Median Follow-up 73 Months; Median Treatment 60 Months) 1 During study treatment, based on Safety Monotherapy population
2 Any time after randomization, including post treatment follow-up
3 Excluding women who had undergone hysterectomy before study entry
Note: Cardiovascular (including cerebrovascular and thromboembolic), skeletal and urogenital/endometrial events and second malignancies were collected life-long. All of these events were assumed to be of CTC Grade 3 to 5 and were not individually graded.
Grades 1-4 Grades 3-4
Adverse Reaction Femara
N=2448
n (%) tamoxifen
N=2447
n (%) Femara
N=2448
n (%) tamoxifen
N=2447
n (%)
Pts with any adverse event 2310 (94.4) 2214 (90.5) 635 (25.9) 604 (24.7)
Hypercholesterolemia 1280 (52.3) 700 (28.6) 11 ( 0.4) 6 ( 0.2)
Hot Flashes/Flushes 821 (33.5) 929 (38.0) 0 - 0 -
Arthralgia/Arthritis 618 (25.2) 501 (20.4) 85 ( 3.5) 50 ( 2.0)
Night Sweats 357 (14.6) 426 (17.4) 0 - 0 -
Bone Fractures2 338 (13.8) 257 (10.5) - - - -
Weight Increase 317 (12.9) 378 (15.4) 27 ( 1.1) 39 ( 1.6)
Nausea 283 (11.6) 277 (11.3) 6 ( 0.2) 9 ( 0.4)
Bone Fractures1 247 (10.1) 174 ( 7.1) - - - -
Fatigue (Lethargy, Malaise, Asthenia) 235 ( 9.6) 250 (10.2) 6 ( 0.2) 7 ( 0.3)
Myalgia 217 ( 8.9) 212 ( 8.7) 18 ( 0.7) 14 ( 0.6)
Edema 164 ( 6.7) 160 ( 6.5) 3 ( 0.1) 1 (<0.1)
Weight Decrease 140 ( 5.7) 129 ( 5.3) 8 ( 0.3) 5 ( 0.2)
Vaginal Bleeding 128 ( 5.2) 320 (13.1) 1 (<0.1) 8 ( 0.3)
Back Pain 125 ( 5.1) 136 ( 5.6) 7 ( 0.3) 11 ( 0.4)
Osteoporosis NOS 124 ( 5.1) 66 ( 2.7) 10 ( 0.4) 5 ( 0.2)
Bone pain 123 ( 5.0) 109 ( 4.5) 6 ( 0.2) 4 ( 0.2)
Depression 119 ( 4.9) 114 ( 4.7) 16 ( 0.7) 14 ( 0.6)
Vaginal Irritation 111 ( 4.5) 77 ( 3.1) 2 (<0.1) 2 (<0.1)
Headache 105 ( 4.3) 94 ( 3.8) 9 ( 0.4) 5 ( 0.2)
Pain in extremity 103 ( 4.2) 79 ( 3.2) 6 ( 0.2) 4 ( 0.2)
Osteopenia 87 ( 3.6) 74 ( 3.0) 0 - 2 (<0.1)
Dizziness/Light-Headedness 84 ( 3.4) 84 ( 3.4) 1 (<0.1) 6 (0.2)
Alopecia 83 ( 3.4) 84 ( 3.4) 0 - 0 -
Vomiting 80 ( 3.3) 80 ( 3.3) 3 ( 0.1) 5 (0.2)
Cataract 49 ( 2.0) 54 ( 2.2) 16 ( 0.7) 17 ( 0.7)
Constipation 49 ( 2.0) 71 ( 2.9) 3 ( 0.1) 1 (<0.1)
Breast pain 37 ( 1.5) 43 ( 1.8) 1 (<0.1) 0 -
Anorexia 20 ( 0.8) 20 ( 0.8) 1 (<0.1) 1 (<0.1)
Endometrial Hyperplasia/ Cancer2, 3 11/1909 ( 0.6) 70/1943 ( 3.6) - - - -
Endometrial Proliferation Disorders 10 (0.3) 71 (1.8) 0 - 14 (0.6)
Endometrial Hyperplasia/ Cancer1, 3 6/1909 ( 0.3) 57/1943 (2.9) - - - -
Other Endometrial Disorders 2 (<0.1) 3 ( 0.1) 0 - 0 -
Myocardial Infarction1 24 ( 1.0) 12 ( 0.5) - - - -
Myocardial Infarction2 37 ( 1.5) 25 (1.0) - - - -
Myocardial Ischemia 6 ( 0.2) 9 ( 0.4) - - - -
Cerebrovascular Accident1 52 ( 2.1) 46 ( 1.9) - - - -
Cerebrovascular Accident2 70 ( 2.9) 63 ( 2.6) - - - -
Angina1 26 ( 1.1) 24 ( 1.0) - - - -
Angina2 32 ( 1.3) 31 ( 1.3) - - - -
Thromboembolic Event1 |
