Table 4.
Most common all-grade and ≥ Grade 3 TEAEs and trTEAEs occurring in ≥ 10% of patients (for all grades in any cohort) in the safety analysis set
| n (%) | TNBC cohort (n = 62) |
HR+/HER2− cohort (n = 26) |
Total (N = 88) |
|||
|---|---|---|---|---|---|---|
| All-grades | ≥ Grade 3 | All-grades | ≥ Grade 3 | All-grades | ≥ Grade 3 | |
| Hematologic TEAEs | ||||||
| Anemia | 51 (82.3) | 22 (35.5) | 26 (100.0) | 13 (50.0) | 77 (87.5) | 35 (39.8) |
| White blood cell count decreased | 35 (56.5) | 12 (19.4) | 21 (80.8) | 7 (26.9) | 56 (63.6) | 19 (21.6) |
| Neutrophil count decreased | 34 (54.8) | 18 (29.0) | 18 (69.2) | 8 (30.8) | 52 (59.1) | 26 (29.5) |
| Platelet count decreased | 18 (29.0) | 5 (8.1) | 10 (38.5) | 3 (11.5) | 28 (31.8) | 8 (9.1) |
| Leukopenia | 8 (12.9) | 3 (4.8) | 6 (23.1) | 2 (7.7) | 14 (15.9) | 5 (5.7) |
| Neutropenia | 6 (9.7) | 3 (4.8) | 5 (19.2) | 2 (7.7) | 11 (12.5) | 5 (5.7) |
| Non-hematologic TEAEs | ||||||
| Nausea | 29 (46.8) | 1 (1.6) | 15 (57.7) | 0 (0.0) | 44 (50.0) | 1 (1.1) |
| Vomiting | 22 (35.5) | 1 (1.6) | 14 (53.8) | 0 (0.0) | 36 (40.9) | 1 (1.1) |
| Decreased appetite | 25 (40.3) | 0 (0.0) | 8 (30.8) | 0 (0.0) | 33 (37.5) | 0 (0.0) |
| Alanine aminotransferase increased | 13 (21.0) | 0 (0.0) | 10 (38.5) | 0 (0.0) | 23 (26.1) | 0 (0.0) |
| Diarrhea | 11 (17.7) | 0 (0.0) | 7 (26.9) | 0 (0.0) | 18 (20.5) | 0 (0.0) |
| Aspartate aminotransferase increased | 10 (16.1) | 1 (1.6) | 7 (26.9) | 0 (0.0) | 17 (19.3) | 1 (1.1) |
| Blood bilirubin increased | 8 (12.9) | 0 (0.0) | 7 (26.9) | 0 (0.0) | 15 (17.0) | 0 (0.0) |
| Malaise | 11 (17.7) | 0 (0.0) | 4 (15.4) | 0 (0.0) | 15 (17.0) | 0 (0.0) |
| Asthenia | 9 (14.5) | 1 (1.6) | 4 (15.4) | 0 (0.0) | 13 (14.8) | 1 (1.1) |
| Upper respiratory tract infection | 6 (9.7) | 0 (0.0) | 7 (26.9) | 1 (3.8) | 13 (14.8) | 1 (1.1) |
| Weight decreased | 11 (17.7) | 0 (0.0) | 1 (3.8) | 0 (0.0) | 12 (13.6) | 0 (0.0) |
| Cough | 6 (9.7) | 0 (0.0) | 4 (15.4) | 0 (0.0) | 10 (11.4) | 0 (0.0) |
| Insomnia | 6 (9.7) | 0 (0.0) | 4 (15.4) | 0 (0.0) | 10 (11.4) | 0 (0.0) |
| Dizziness | 6 (9.7) | 0 (0.0) | 3 (11.5) | 0 (0.0) | 9 (10.2) | 0 (0.0) |
| Hematologic trTEAEs | ||||||
| Anemia | 51 (82.3) | 22 (35.5) | 26 (100.0) | 13 (50.0) | 77 (87.5) | 35 (39.8) |
| White blood cell count decreased | 35 (56.5) | 12 (19.4) | 20 (76.9) | 7 (26.9) | 55 (62.5) | 19 (21.6) |
| Neutrophil count decreased | 34 (54.8) | 18 (29.0) | 17 (65.4) | 8 (30.8) | 51 (58.0) | 26 (29.5) |
| Platelet count decreased | 18 (29.0) | 5 (8.1) | 10 (38.5) | 3 (11.5) | 28 (31.8) | 8 (9.1) |
| Leukopenia | 8 (12.9) | 3 (4.8) | 6 (23.1) | 2 (7.7) | 14 (15.9) | 5 (5.7) |
| Neutropenia | 6 (9.7) | 3 (4.8) | 5 (19.2) | 2 (7.7) | 11 (12.5) | 5 (5.7) |
| Non-hematologic trTEAEs | ||||||
| Nausea | 28 (45.2) | 1 (1.6) | 15 (57.7) | 0 (0.0) | 43 (48.9) | 1 (1.1) |
| Vomiting | 21 (33.9) | 1 (1.6) | 12 (46.2) | 0 (0.0) | 33 (37.5) | 1 (1.1) |
| Decreased appetite | 23 (37.1) | 0 (0.0) | 8 (30.8) | 0 (0.0) | 31 (35.2) | 0 (0.0) |
| Alanine aminotransferase increased | 10 (16.1) | 0 (0.0) | 9 (34.6) | 0 (0.0) | 19 (21.6) | 0 (0.0) |
| Diarrhea | 11 (17.7) | 0 (0.0) | 6 (23.1) | 0 (0.0) | 17 (19.3) | 0 (0.0) |
| Aspartate aminotransferase increased | 10 (16.1) | 1 (1.6) | 6 (23.1) | 0 (0.0) | 16 (18.2) | 1 (1.1) |
| Malaise | 11 (17.7) | 0 (0.0) | 4 (15.4) | 0 (0.0) | 15 (17.0) | 0 (0.0) |
| Blood bilirubin increased | 7 (11.3) | 0 (0.0) | 7 (26.9) | 0 (0.0) | 14 (15.9) | 0 (0.0) |
| Weight decreased | 11 (17.7) | 0 (0.0) | 1 (3.8) | 0 (0.0) | 12 (13.6) | 0 (0.0) |
| Asthenia | 8 (12.9) | 1 (1.6) | 4 (15.4) | 0 (0.0) | 12 (13.6) | 1 (1.1) |
AEs were graded according to NCI CTCAE (v4.03). A patient with multiple AEs under a system organ class and preferred term was counted only once for the system organ class and preferred term, under the maximum severity category. Data cutoff: October 9, 2020
AE adverse event, HER2- human epidermal growth factor receptor 2-negative, HR + hormone receptor-positive, NCI CTCAE National Cancer Institute Common Terminology Criteria for Adverse Events, TEAE treatment-emergent adverse event, trTEAE treatment-related treatment-emergent adverse event, TNBC triple-negative breast cancer