Table 2. Summary of Adverse Events of Any Grade Occurring in More Than 15% of Patients in Either Study Group.
| Variable | No. (%) | |||||
|---|---|---|---|---|---|---|
| Fulvestrant-palbociclib (n = 241) | Letrozole-palbociclib (n = 242) | |||||
| Any | Grade 3 | Grade 4 | Any | Grade 3 | Grade 4 | |
| Any AE | 240 (99.6) | 167 (69.3) | 28 (11.6) | 240 (99.2) | 168 (69.4) | 22 (9.1) |
| Hematologic AEsa | ||||||
| Neutropenia | 198 (82.2) | 141 (58.5) | 18 (7.5) | 207 (85.5) | 153 (63.2) | 12 (5.0) |
| Leukopenia | 60 (24.9) | 16 (6.6) | 1 (0.4) | 61 (25.2) | 14 (5.8) | 0 |
| Anemia | 55 (22.8) | 6 (2.5) | 0 | 68 (28.1) | 6 (2.5) | 0 |
| Thrombocytopenia | 49 (20.3) | 3 (1.2) | 0 | 39 (16.1) | 1 (0.4) | 1 (0.4) |
| Nonhematologic AEs | ||||||
| Asthenia | 90 (37.3) | 7 (2.9) | 0 | 87 (36.0) | 5 (2.1) | 0 |
| Diarrhea | 65 (27.0) | 4 (1.7) | 0 | 60 (24.8) | 3 (1.2) | 0 |
| Arthralgia | 62 (25.7) | 1 (0.4) | 0 | 80 (33.1) | 1 (0.4) | 0 |
| Fatigue | 62 (25.7) | 4 (1.7) | 0 | 63 (26.0) | 4 (1.7) | 0 |
| Back pain | 57 (23.7) | 7 (2.9) | 0 | 49 (20.2) | 1 (0.4) | 0 |
| Nausea | 57 (23.7) | 3 (1.2) | 0 | 45 (18.6) | 0 | 0 |
| Alopecia | 56 (23.2) | 0 | 0 | 61 (25.2) | 0 | 0 |
| Cough | 54 (22.4) | 0 | 0 | 42 (17.4) | 0 | 0 |
| Hot flush | 41 (17.0) | 0 | 0 | 46 (19.0) | 0 | 0 |
| Stomatitis | 40 (16.6) | 0 | 0 | 48 (19.8) | 2 (0.8) | 0 |
| Vomiting | 35 (14.5) | 2 (0.8) | 0 | 39 (16.1) | 2 (0.8) | 0 |
| Constipation | 34 (14.1) | 0 | 0 | 40 (16.5) | 3 (1.2) | 0 |
Abbreviation: AEs, adverse events.
a
Five patients died due to unrelated AEs, 3 of whom (1.2%) were randomized to fulvestrant-palbociclib and 2 (0.8%) to letrozole-palbociclib.