Adverse Reactions | Grades 1-4 | Grades 3-4 | ||||||
---|---|---|---|---|---|---|---|---|
Letrozole tablets N=2448 n (%) |
Tamoxifen N=2447 n (%) |
Letrozole tablets N=2448 n (%) |
Tamoxifen N=2447 n (%) |
|||||
TIA = Transient ischemic attack Note: Cardiovascular events (including cerebrovascular and thromboembolic events), skeletal and urogenital/endometrial events and second primary malignancies were collected life -long. All of these events were assumed to be of CTC Grade 3 to 5 and were not individually graded |
||||||||
Patients with any adverse reaction | 2309 | (94.3) | 2212 | (90.4) | 636 | (26.0) | 606 | (24.8) |
Hypercholesterolemia |
1280 | (52.3) | 700 | (28.6) | 11 | (0.4) | 6 | (0.2) |
Hot flashes |
819 | (33.5) | 929 | (38.0) | - | - | - | - |
Arthralgia/arthritis |
621 | (25.4) | 504 | (20.6) | 84 | (3.4) | 50 | (2.0) |
Bone fractures |
361 | (14.7) | 280 | (11.4) | - | - | - | - |
Night sweats |
356 | (14.5) | 426 | (17.4) | - | - | - | - |
Weight increase |
317 | (12.9) | 378 | (15.4) | 27 | (1.1) | 39 | (1.6) |
Nausea |
284 | (11.6) | 277 | (11.3) | 6 | (0.2) | 9 | (0.4) |
Bone fractures |
249 | (10.2) | 175 | (7.2) | - | - | - | - |
Fatigue (lethargy, malaise, asthenia) |
235 | (9.6) | 250 | (10.2) | 6 | (0.2) | 7 | (0.3) |
Myalgia |
221 | (9.0) | 212 | (8.7) | 18 | (0.7) | 14 | (0.6) |
Vaginal bleeding |
129 | (5.3) | 320 | (13.1) | 1 | (<0.1) | 8 | (0.3) |
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) |
Osteoporosis |
126 | (5.1) | 67 | (2.7) | 10 | (0.4) | 5 | (0.2) |
Back pain | 125 | (5.1) | 136 | (5.6) | 7 | (0.3) | 11 | (0.4) |
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 |
112 | (4.6) | 77 | (3.1) | 2 | (<0.1) | 2 | (<0.1) |
Headache |
105 | (4.3) | 94 | (3.8) | 8 | (0.3) | 4 | (0.2) |
Pain in extremity | 103 | (4.2) | 79 | (3.2) | 6 | (0.2) | 4 | (0.2) |
Osteopenia |
87 | (3.6) | 76 | (3.1) | 0 | - | 3 | (0.1) |
Dizziness/light-headedness |
84 | (3.4) | 80 | (3.3) | 1 | (<0.1) | 6 | (0.2) |
Alopecia | 83 | (3.4) | 84 | (3.4) | - | - | - | - |
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) |
Myocardial infarction |
42 | (1.7) | 28 | (1.1) | - | - | - | - |
Breast pain |
37 | (1.5) | 43 | (1.8) | 1 | (<0.1) | - | - |
Anorexia |
20 | (0.8) | 20 | (0.8) | 1 | (<0.1) | 1 | (<0.1) |
Endometrial proliferation disorders |
14 | (0.6) | 86 | (3.5) | 0 | - | 14 | (0.6) |
Ovarian cyst |
11 | (0.4) | 18 | (0.7) | 4 | (0.2) | 4 | (0.2) |
Endometrial hyperplasia/cancer |
11 | (0.4) | 72 | (2.9) | - | - | - | - |
Endometrial hyperplasia/cancer |
6/1909 | (0.3) | 57/1943 | (2.9) | - | - | - | - |
Other endometrial disorders |
2 | (<0.1) | 3 | (0.1) | 0 | - | 0 | - |
Myocardial infarction |
24 | (1.0) | 12 | (0.5) | - | - | - | - |
Myocardial ischemia | 6 | (0.2) | 9 | (0.4) | - | - | - | - |
Cerebrovascular accident/TIA |
74 | (3.0) | 68 | (2.8) | - | - | - | - |
Cerebrovascular accident/TIA |
51 | (2.1) | 47 | (1.9) | - | - | - | - |
Angina requiring surgery |
35 | (1.4) | 33 | (1.3) | - | - | - | - |
Angina requiring surgery |
25 | (1.0) | 25 | (1.0) | - | - | - | - |
Thromboembolic event |
79 | (3.2) | 113 | (4.6) | - | - | - | - |
Thromboembolic event |
51 | (2.1) | 89 | (3.6) | - | - | - | - |
Cardiac failure |
39 | (1.6) | 34 | (1.4) | - | - | - | - |
Cardiac failure |
27 | (1.1) | 15 | (0.6) | - | - | - | - |
Hypertension |
160 | (6.5) | 175 | (7.2) | - | - | - | - |
Hypertension |
138 | (5.6) | 139 | (5.7) | - | - | - | - |
Other cardiovascular |
172 | (7.0) | 174 | (7.1) | - | - | - | - |
Other cardiovascular |
120 | (4.9) | 119 | (4.9) | - | - | - | - |
Second primary malignancy |
129 | (5.3) | 150 | (6.1) | - | - | - | - |
Second primary malignancy |
54 | (2.2) | 79 | (3.2) | - | - | - | - |
Adverse Reactions | Letrozole N = 2049 n (%) |
Anastrozole N = 2062 n (%) |
||
---|---|---|---|---|
Grade 3/4 n (%) |
All grades n (%) |
Grade 3/4 n (%) |
All grades n (%) |
|
Patients with at least one AR | 628 (30.6) | 2049 (100.0) | 591 (28.7) | 2062 (100.0) |
Arthralgia | 80 (3.9) | 987 (48.2) | 69 (3.3) | 987 (47.9) |
Hot flush | 17 (0.8) | 666 (32.5) | 9 (0.4) | 666 (32.3) |
Fatigue | 8 (0.4) | 345 (16.8) | 10 (0.5) | 343 (16.6) |
Osteoporosis | 5 (0.2) | 223 (10.9) | 11 (0.5) | 225 (10.9) |
Myalgia | 16 (0.8) | 233 (11.4) | 15 (0.7) | 212 (10.3) |
Back pain | 11 (0.5) | 212 (10.3) | 17 (0.8) | 193 (9.4) |
Osteopenia | 4 (0.2) | 203 (9.9) | 1 (0.0) | 173 (8.4) |
Pain in extremity | 9 (0.4) | 168 (8.2) | 3 (0.1) | 174 (8.4) |
Lymphoedema | 5 (0.2) | 159 (7.8) | 2 (0.1) | 179 (8.7) |
Insomnia | 7 (0.3) | 160 (7.8) | 3 (0.1) | 149 (7.2) |
Hypercholesterolemia | 2 (0.1) | 155 (7.6) | 1 (0.0) | 151 (7.3) |
Hypertension | 25 (1.2) | 156 (7.6) | 20 (1.0) | 149 (7.2) |
Depression | 16 (0.8) | 147 (7.2) | 13 (0.6) | 137 (6.6) |
Bone pain | 10 (0.5) | 138 (6.7) | 9 (0.4) | 122 (5.9) |
Nausea | 6 (0.3) | 137 (6.7) | 5 (0.2) | 152 (7.4) |
Headache | 3 (0.1) | 130 (6.3) | 5 (0.2) | 168 (8.1) |
Alopecia | 2 (0.1) | 127 (6.2) | 0 (0.0) | 134 (6.5) |
Musculoskeletal pain | 6 (0.3) | 123 (6.0) | 9 (0.4) | 147 (7.1) |
Radiation skin injury | 11 (0.5) | 120 (5.9) | 6 (0.3) | 88 (4.3) |
Dyspnea | 16 (0.8) | 118 (5.8) | 10 (0.5) | 96 (4.7) |
Cough | 1 (0.0) | 106 (5.2) | 1 (0.0) | 120 (5.8) |
Musculoskeletal stiffness | 2 (0.1) | 102 (5.0) | 2 (0.1) | 84 (4.1) |
Dizziness | 2 (0.2) | 94 (4.6) | 7 (0.3) | 109 (5.3) |
Number (%) of Patients with Grade 1-4 Adverse Reactions | Number (%) of Patients with Grade 3-4 Adverse Reactions | |||
---|---|---|---|---|
Letrozole tablets N=2563 |
Placebo N=2573 |
Letrozole tablets N=2563 |
Placebo N=2573 |
|
|
2232 (87.1) | 2174 (84.5) | 419 (16.3) | 389 (15.1) |
|
1375 (53.6) | 1230 (47.8) | 59 (2.3) | 74 (2.9) |
Flushing | 1273 (49.7) | 1114 (43.3) | 3 (0.1) | 0 |
|
1154 (45) | 1090 (42.4) | 30 (1.2) | 28 (1.1) |
Asthenia | 862 (33.6) | 826 (32.1) | 16 (0.6) | 7 (0.3) |
Edema NOS | 471 (18.4) | 416 (16.2) | 4 (0.2) | 3 (0.1) |
|
978 (38.2) | 836 (32.5) | 71 (2.8) | 50 (1.9) |
Arthralgia | 565 (22) | 465 (18.1) | 25 (1) | 20 (0.8) |
Arthritis NOS | 173 (6.7) | 124 (4.8) | 10 (0.4) | 5 (0.2) |
Myalgia | 171 (6.7) | 122 (4.7) | 8 (0.3) | 6 (0.2) |
Back Pain | 129 (5) | 112 (4.4) | 8 (0.3) | 7 (0.3) |
|
863 (33.7) | 819 (31.8) | 65 (2.5) | 58 (2.3) |
Headache | 516 (20.1) | 508 (19.7) | 18 (0.7) | 17 (0.7) |
Dizziness | 363 (14.2) | 342 (13.3) | 9 (0.4) | 6 (0.2) |
|
830 (32.4) | 787 (30.6) | 17 (0.7) | 16 (0.6) |
Sweating Increased | 619 (24.2) | 577 (22.4) | 1 (<0.1) | 0 |
|
725 (28.3) | 731 (28.4) | 43 (1.7) | 42 (1.6) |
Constipation | 290 (11.3) | 304 (11.8) | 6 (0.2) | 2 (<0.1) |
Nausea | 221 (8.6) | 212 (8.2) | 3 (0.1) | 10 (0.4) |
Diarrhea NOS | 128 (5) | 143 (5.6) | 12 (0.5) | 8 (0.3) |
|
551 (21.5) | 537 (20.9) | 24 (0.9) | 32 (1.2) |
Hypercholesterolemia | 401 (15.6) | 398 (15.5) | 2 (<0.1) | 5 (0.2) |
|
303 (11.8) | 357 (13.9) | 9 (0.4) | 8 (0.3) |
Vaginal Hemorrhage | 123 (4.8) | 171 (6.6) | 2 (<0.1) | 5 (0.2) |
Vulvovaginal Dryness | 137 (5.3) | 127 (4.9) | 0 | 0 |
|
320 (12.5) | 276 (10.7) | 21 (0.8) | 16 (0.6) |
Insomnia | 149 (5.8) | 120 (4.7) | 2 (<0.1) | 2 (<0.1) |
|
279 (10.9) | 260 (10.1) | 30 (1.2) | 28 (1.1) |
Dyspnea | 140 (5.5) | 137 (5.3) | 21 (0.8) | 18 (0.7) |
|
184 (7.2) | 147 (5.7) | 13 (0.5) | 13 (0.5) |
|
166 (6.5) | 163 (6.3) | 40 (1.6) | 33 (1.3) |
|
130 (5.1) | 100 (3.9) | 12 (0.5) | 6 (0.2) |
Adverse Reaction | Letrozole tablets 2.5 mg (N=455) % |
Tamoxifen 20 mg (N=455) % |
---|---|---|
|
||
Fatigue | 13 | 13 |
Chest Pain | 8 | 9 |
Edema Peripheral | 5 | 6 |
Pain NOS | 5 | 7 |
Weakness | 6 | 4 |
|
||
Weight Decreased | 7 | 5 |
|
||
Hot Flushes | 19 | 16 |
Hypertension | 8 | 4 |
|
||
Nausea | 17 | 17 |
Constipation | 10 | 11 |
Diarrhea | 8 | 4 |
Vomiting | 7 | 8 |
|
||
Influenza | 6 | 4 |
Urinary Tract Infection NOS | 6 | 3 |
|
||
Post-Mastectomy Lymphedema | 7 | 7 |
|
||
Anorexia | 4 | 6 |
|
||
Bone Pain | 22 | 21 |
Back Pain | 18 | 19 |
Arthralgia | 16 | 15 |
Pain in Limb | 10 | 8 |
|
||
Headache NOS | 8 | 7 |
|
||
Insomnia | 7 | 4 |
|
||
Breast Pain | 7 | 7 |
|
||
Dyspnea | 18 | 17 |
Cough | 13 | 13 |
Chest Wall Pain | 6 | 6 |
Adverse Reaction | Pooled Letrozole tablets 2.5 mg (N=359) % |
Pooled Letrozole tablets 0.5 mg (N=380) % |
megestrol acetate 160 mg (N=189) % |
aminoglutethimide 500 mg (N=178) % |
---|---|---|---|---|
|
||||
Chest Pain | 6 | 3 | 7 | 3 |
Peripheral Edema |
5 | 5 | 8 | 3 |
Asthenia | 4 | 5 | 4 | 5 |
Weight Increase | 2 | 2 | 9 | 3 |
|
||||
Hypertension | 5 | 7 | 5 | 6 |
|
||||
Nausea | 13 | 15 | 9 | 14 |
Vomiting | 7 | 7 | 5 | 9 |
Constipation | 6 | 7 | 9 | 7 |
Diarrhea | 6 | 5 | 3 | 4 |
Pain-Abdominal | 6 | 5 | 9 | 8 |
Anorexia | 5 | 3 | 5 | 5 |
Dyspepsia | 3 | 4 | 6 | 5 |
|
||||
Viral Infection | 6 | 5 | 6 | 3 |
|
||||
Hypercholesterolemia | 3 | 3 | 0 | 6 |
|
||||
Musculoskeletal |
21 | 22 | 30 | 14 |
Arthralgia | 8 | 8 | 8 | 3 |
|
||||
Headache | 9 | 12 | 9 | 7 |
Somnolence | 3 | 2 | 2 | 9 |
Dizziness | 3 | 5 | 7 | 3 |
|
||||
Dyspnea | 7 | 9 | 16 | 5 |
Coughing | 6 | 5 | 7 | 5 |
|
||||
Hot Flushes | 6 | 5 | 4 | 3 |
Rash |
5 | 4 | 3 | 12 |
Pruritus | 1 | 2 | 5 | 3 |
Primary Core Analysis (PCA) |
Monotherapy Arms Analysis (MAA) |
|||
---|---|---|---|---|
Characteristic | Letrozole tablets N=4003 n (%) |
Tamoxifen N=4007 n (%) |
Letrozole tablets N=2463 n (%) |
Tamoxifen N=2459 n (%) |
Age (median, years) | 61 | 61 | 61 | 61 |
Age range (years) | 38-89 | 39-90 | 38-88 | 39-90 |
Hormone receptor status (%) | ||||
ER+ and/or PgR+ | 99.7 | 99.7 | 99.7 | 99.7 |
Both unknown | 0.3 | 0.3 | 0.3 | 0.3 |
Nodal status (%) | ||||
Node negative | 52 | 52 | 50 | 52 |
Node positive | 41 | 41 | 43 | 41 |
Nodal status unknown | 7 | 7 | 7 | 7 |
Prior adjuvant chemotherapy (%) | 24 | 24 | 24 | 24 |
Letrozole tablets N=2463 |
Tamoxifen N=2459 |
Hazard ratio | |||||
---|---|---|---|---|---|---|---|
Events (%) |
5-year rate | Events (%) |
5-year rate | (95% CI) |
|
||
ITT analysis ignores selective crossover in tamoxifen arms. | |||||||
Censored analysis censors follow-up at the date of selective crossover in 632 patients who crossed to letrozole tablets or another aromatase inhibitor after the tamoxifen arms were unblinded in 2005. | |||||||
Definition of: | |||||||
Disease-free survival |
ITT | 445 (18.1) | 87.4 | 500 (20.3) | 84.7 | 0.87 (0.76, 0.99) | 0.03 |
Censor | 445 | 87.4 | 483 | 84.2 | 0.84 (0.73, 0.95) | ||
0 positive nodes | ITT | 165 | 92.2 | 189 | 90.3 | 0.88 (0.72, 1.09) | |
1-3 positive nodes | ITT | 151 | 85.6 | 163 | 83.0 | 0.85 (0.68, 1.06) | |
>=4 positive nodes | ITT | 123 | 71.2 | 142 | 62.6 | 0.81 (0.64, 1.03) | |
Adjuvant chemotherapy | ITT | 119 | 86.4 | 150 | 80.6 | 0.77 (0.60, 0.98) | |
No chemotherapy | ITT | 326 | 87.8 | 350 | 86.1 | 0.91 (0.78, 1.06) | |
Systemic DFS |
ITT | 401 | 88.5 | 446 | 86.6 | 0.88 (0.77, 1.01) | |
Time to distant metastasis |
ITT | 257 | 92.4 | 298 | 90.1 | 0.85 (0.72, 1.00) | |
Adjuvant chemotherapy | ITT | 84 | - | 109 | - | 0.75 (0.56, 1.00) | |
No chemotherapy | ITT | 173 | - | 189 | - | 0.90 (0.73, 1.11) | |
Distant DFS |
ITT | 385 | 89.0 | 432 | 87.1 | 0.87 (0.76, 1.00) | |
Contralateral breast cancer | ITT | 34 | 99.2 | 44 | 98.6 | 0.76 (0.49, 1.19) | |
Overall survival | ITT | 303 | 91.8 | 343 | 90.9 | 0.87 (0.75, 1.02) | |
Censor | 303 | 91.8 | 338 | 90.1 | 0.82 (0.70, 0.96) | ||
0 positive nodes | ITT | 107 | 95.2 | 121 | 94.8 | 0.90 (0.69, 1.16) | |
1-3 positive nodes | ITT | 99 | 90.8 | 114 | 90.6 | 0.81 (0.62, 1.06) | |
>=4 positive nodes | ITT | 92 | 80.2 | 104 | 73.6 | 0.86 (0.65, 1.14) | |
Adjuvant chemotherapy | ITT | 76 | 91.5 | 96 | 88.4 | 0.79 (0.58, 1.06) | |
No chemotherapy | ITT | 227 | 91.9 | 247 | 91.8 | 0.91 (0.76, 1.08) |
|
Baseline Status | Letrozole tablets N=2582 |
Placebo N=2586 |
---|---|---|
|
||
ER+ and/or PgR+ | 98 | 98 |
Both Unknown | 2 | 2 |
|
||
Node Negative | 50 | 50 |
Node Positive | 46 | 46 |
Nodal Status Unknown | 4 | 4 |
|
46 | 46 |
Letrozole tablets N = 2582 |
Placebo N = 2586 |
Hazard Ratio (95% CI) |
|
|
---|---|---|---|---|
CI = confidence interval for hazard ratio. Hazard ratio of less than 1.0 indicates difference in favor of letrozole tablets (lesser risk of recurrence); hazard ratio greater than 1.0 indicates difference in favor of placebo (higher risk of recurrence with letrozole tablets). | ||||
|
||||
|
122 (4.7%) | 193 (7.5%) | 0.62 (0.49, 0.78) |
0.00003 |
Local Breast Recurrence | 9 | 22 | ||
Local Chest Wall Recurrence | 2 | 8 | ||
Regional Recurrence | 7 | 4 | ||
Distant Recurrence | 55 | 92 | 0.61 (0.44 - 0.84) | 0.003 |
Contralateral Breast Cancer | 19 | 29 | ||
Deaths Without Recurrence or Contralateral Breast Cancer | 30 | 38 |
Letrozole tablets N = 2582 (%) |
Placebo N = 2586 (%) |
Hazard Ratio (95% CI) |
|
|
---|---|---|---|---|
|
344 (13.3) | 402 (15.5) | 0.89 (0.77, 1.03) | 0.12 |
(Protocol definition of DFS events |
209 | 286 | 0.75 (0.63, 0.89) | 0.001 |
Local Breast Recurrence | 15 | 44 | ||
Local Chest Wall Recurrence | 6 | 14 | ||
Regional Recurrence | 10 | 8 | ||
Distant Recurrence | 140 | 167 | ||
Distant Recurrence (first or subsequent events) |
142 | 169 | 0.88 (0.70, 1.10) | 0.246 |
Contralateral Breast Cancer | 37 | 53 | ||
Deaths Without Recurrence or Contralateral Breast Cancer | 135 | 116 |
Baseline Status | Letrozole tablets N=458 |
Tamoxifen N=458 |
---|---|---|
|
||
IIIB | 6% | 7% |
IV | 93% | 92% |
|
||
ER and PgR Positive | 38% | 41% |
ER or PgR Positive | 26% | 26% |
Both Unknown | 34% | 33% |
ER- or PgR-/Other Unknown | <1% | 0 |
|
||
Adjuvant | 19% | 18% |
None | 81% | 82% |
|
||
Soft Tissue | 25% | 25% |
Bone | 32% | 29% |
Viscera | 43% | 46% |
Letrozole tablets 2.5 mg N=453 |
Tamoxifen 20 mg N=454 |
Hazard or Odds Ratio (95% CI) |
|
---|---|---|---|
|
9.4 months | 6.0 months | 0.72 (0.62, 0.83) |
|
|||
(CR + PR) | 145 (32%) | 95 (21%) | 1.77 (1.31, 2.39) |
(CR) | 42 (9%) | 15 (3%) | 2.99 (1.63, 5.47) |
|
|||
Median | 18 months (N=145) |
16 months (N=95) |
|
|
35 months (N=458) |
32 months (N=458) |
|
|
Variable | Letrozole tablets 2.5 mg N=84 |
Tamoxifen 20 mg N=83 |
---|---|---|
|
8.9 months (6.2, 12.5) | 5.9 months (3.2, 6.2) |
Hazard Ratio for TTP (95% CI) | 0.60 (0.43, 0.84) | |
|
||
(CR + PR) | 22 (26%) | 7 (8%) |
Odds Ratio for Response (95% CI) | 3.85 (1.50, 9.60) |
Letrozole tablets 2.5 mg |
Tamoxifen 20 mg |
|
---|---|---|
|
||
|
N=113 | N=115 |
Median TTP | 12.1 months | 6.4 months |
Objective Response Rate | 50% | 34% |
|
N=145 | N=131 |
Median TTP | 9.5 months | 6.3 months |
Objective Response Rate | 23% | 15% |
|
N=195 | N=208 |
Median TTP | 8.3 months | 4.6 months |
Objective Response Rate | 28% | 17% |
Variable | Letrozole tablets 2.5 mg |
Tamoxifen 20 mg |
---|---|---|
|
N=294 | N=305 |
Median Time to Progression (95% CI) | 9.4 months (8.9, 11.8) | 6.0 months (5.1, 8.5) |
Hazard Ratio for TTP (95% CI) | 0.69 (0.58, 0.83) | |
Objective Response Rate (CR+PR) | 97 (33%) | 66 (22%) |
Odds Ratio for Response (95% CI) | 1.78 (1.20, 2.60) | |
|
N=159 | N=149 |
Median Time to Progression (95% CI) | 9.2 months (6.1, 12.3) | 6.0 months (4.1, 6.4) |
Hazard Ratio for TTP (95% CI) | 0.77 (0.60, 0.99) | |
Objective Response Rate (CR+PR) | 48 (30%) | 29 (20%) |
Odds Ratio for Response (95% CI) | 1.79 (1.10, 3.00) |
|
Parameter | megestrol acetate study | aminoglutethimide study |
---|---|---|
|
552 | 557 |
|
||
ER/PR Positive | 57% | 56% |
ER/PR Unknown | 43% | 44% |
|
||
Adjuvant Only | 33% | 38% |
Therapeutic +/- Adj. | 66% | 62% |
|
||
Soft Tissue | 56% | 50% |
Bone | 50% | 55% |
Viscera | 40% | 44% |
Letrozole tablets 0.5 mg N=188 |
Letrozole tablets 2.5 mg N=174 |
megestrol acetate N=190 |
|
---|---|---|---|
|
22 (11.7%) | 41 (23.6%) | 31 (16.3%) |
|
552 days | (Not reached) | 561 days |
|
154 days | 170 days | 168 days |
|
633 days | 730 days | 659 days |
|
Letrozole tablets 2.5: Letrozole tablets 0.5=2.33 (95% CI: 1.32, 4.17); |
Letrozole tablets 2.5: megestrol=1.58 (95% CI: 0.94, 2.66); |
|
|
Letrozole tablets 2.5: Letrozole tablets 0.5=0.81 (95% CI: 0.63, 1.03); |
Letrozole tablets 2.5: megestrol=0.77 (95% CI: 0.60, 0.98); |
|
Letrozole tablets 0.5 mg N=193 |
Letrozole tablets 2.5 mg N=185 |
aminoglutethimide N=179 |
|
---|---|---|---|
|
34 (17.6%) | 34 (18.4%) | 22 (12.3%) |
|
619 days | 706 days | 450 days |
|
103 days | 123 days | 112 days |
|
636 days | 792 days | 592 days |
|
Letrozole tablets 2.5: Letrozole tablets 0.5=1.05 (95% CI: 0.62, 1.79); |
Letrozole tablets 2.5: aminoglutethimide=1.61 (95% CI: 0.90, 2.87); |
|
|
Letrozole tablets 2.5: Letrozole tablets 0.5=0.86 (95% CI: 0.68, 1.11); |
Letrozole tablets 2.5: aminoglutethimide=0.74 (95% CI: 0.57, 0.94); |
2.5 milligram tablets | |
Bottles of 30 tablets | NDC 51991-759-33 |
Bottle of 90 tablets | NDC 51991-759-90 |
Bottles of 1000 tablets | NDC 51991-759-10 |