Table 2.
Targeted Adverse Events Reported during Follow-up, According to Treatment Assignment.*
| Adverse Event | Exemestane plus Ovarian Suppression (N = 2318) | Tamoxifen plus Ovarian Suppression (N = 2325) | ||||||
|---|---|---|---|---|---|---|---|---|
| Any Event | Grade 3 or 4 Event | Any Event | Grade 3 or 4 Event | |||||
| no. of patients with event | % (95% CI) | no. of patients with event | % (95% CI) | no. of patients with event | % (95% CI) | no. of patients with event | % (95% CI) | |
| Allergic reaction or hypersensitivity | 115 | 5.0 (4.1–5.9) | 11 | 0.5 (0.2–0.8) | 107 | 4.6 (3.8–5.5) | 9 | 0.4 (0.2–0.7) |
|
| ||||||||
| Injection-site reaction | 168 | 7.2 (6.2–8.4) | 1 | <0.1 (0.0–0.2) | 187 | 8.0 (7.0–9.2) | 1 | <0.1 (0.0–0.2) |
|
| ||||||||
| Hot flushes | 2125 | 91.7 (90.5–92.8) | 232 | 10.0 (8.8–11.3) | 2169 | 93.3 (92.2–94.3) | 279 | 12.0 (10.7–13.4) |
|
| ||||||||
| Depression | 1165 | 50.3 (48.2–52.3) | 87 | 3.8 (3.0–4.6) | 1164 | 50.1 (48.0–52.1) | 102 | 4.4 (3.6–5.3) |
|
| ||||||||
| Sweating | 1264 | 54.5 (52.5–56.6) | — | — | 1371 | 59.0 (56.9–61.0) | — | — |
|
| ||||||||
| Insomnia | 1348 | 58.2 (56.1–60.2) | 89 | 3.8 (3.1–4.7) | 1361 | 58.5 (56.5–60.5) | 100 | 4.3 (3.5–5.2) |
|
| ||||||||
| Fatigue | 1420 | 61.3 (59.2–63.2) | 73 | 3.1 (2.5–3.9) | 1463 | 62.9 (60.9–64.9) | 67 | 2.9 (2.2–3.6) |
|
| ||||||||
| Hypertension | 527 | 22.7 (21.0–24.5) | 151 | 6.5 (5.5–7.6) | 509 | 21.9 (20.2–23.6) | 169 | 7.3 (6.2–8.4) |
|
| ||||||||
| Cardiac ischemia or infarction | 16 | 0.7 (0.4–1.1) | 7 | 0.3 (0.1–0.6) | 7 | 0.3 (0.1–0.6) | 3 | 0.1 (0.0–0.4) |
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| ||||||||
| Thrombosis or embolism | 24 | 1.0 (0.7–1.5) | 19 | 0.8 (0.5–1.3) | 50 | 2.2 (1.6–2.8) | 45 | 1.9 (1.4–2.6) |
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| ||||||||
| Nausea | 721 | 31.1 (29.2–33.0) | 17 | 0.7 (0.4–1.2) | 671 | 28.9 (27.0–30.7) | 13 | 0.6 (0.3–1.0) |
|
| ||||||||
| Musculoskeletal symptoms | 2057 | 88.7 (87.4–90.0) | 254 | 11.0 (9.7–12.3) | 1766 | 76.0 (74.2–77.7) | 122 | 5.2 (4.4–6.2) |
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| Osteoporosis | 894 | 38.6 (36.6–40.6) | 10 | 0.4 (0.2–0.8) | 586 | 25.2 (23.5–27.0) | 6 | 0.3 (0.1–0.6) |
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| Fractures | 158 | 6.8 (5.8–7.9) | 29 | 1.3 (0.8–1.8) | 120 | 5.2 (4.3–6.1) | 18 | 0.8 (0.5–1.2) |
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| Vaginal dryness | 1214 | 52.4 (50.3–54.4) | — | — | 1101 | 47.4 (45.3–49.4) | — | — |
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| Decreased libido | 1042 | 45.0 (42.9–47.0) | — | — | 950 | 40.9 (38.9–42.9) | — | — |
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| Dyspareunia | 707 | 30.5 (28.6–32.4) | 53 | 2.3 (1.7–3.0) | 601 | 25.8 (24.1–27.7) | 32 | 1.4 (0.9–1.9) |
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| Urinary incontinence | 304 | 13.1 (11.8–14.6) | 6 | 0.3 (0.1–0.6) | 414 | 17.8 (16.3–19.4) | 7 | 0.3 (0.1–0.6) |
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| ||||||||
| CNS cerebrovascular ischemia | 5 | 0.2 (0.1–0.5) | 4 | 0.2 (0.0–0.4) | 11 | 0.5 (0.2–0.8) | 8 | 0.3 (0.1–0.7) |
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| ||||||||
| CNS hemorrhage | 15 | 0.6 (0.4–1.1) | 1 | <0.1 (0.0–0.2) | 21 | 0.9 (0.6–1.4) | 2 | 0.1 (0.0–0.3) |
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| Glucose intolerance† | 54 | 2.3 (1.8–3.0) | 11 | 0.5 (0.2–0.8) | 54 | 2.3 (1.7–3.0) | 15 | 0.6 (0.4–1.1) |
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| ||||||||
| Hyperglycemia† | 61 | 2.6 (2.0–3.4) | 13 | 0.6 (0.3–1.0) | 80 | 3.4 (2.7–4.3) | 15 | 0.6 (0.4–1.1) |
|
| ||||||||
| Any targeted adverse event | 2279 | 98.3 (97.7–98.8) | 710 | 30.6 (28.8–32.6) | 2285 | 98.3 (97.7–98.8) | 683 | 29.4 (27.5–31.3) |
*
The information here includes data from the 4643 patients in the safety population who received a protocol-assigned treatment. Targeted adverse events and other adverse events of grade 3 or higher were categorized according to the Common Terminology Criteria for Adverse Events, version 3.0.11 Dashes indicate that grade 3 or 4 was not a possible grading for that adverse event. No patient had a targeted adverse event of grade 5. CNS denotes central nervous system.
†
Glucose intolerance (diabetes) and hyperglycemia were added as targeted adverse events in 2011 and therefore may be underreported.