Table 3.
Overall summary of TEAEs and trTEAEs in the safety analysis set
| n (%) | TNBC cohort (n = 62) |
HR+/HER2− cohort (n = 26) |
Total (N = 88) |
|---|---|---|---|
| Patients with at least one TEAE | 61 (98.4) | 26 (100.0) | 87 (98.9) |
| ≥ Grade 3 | 37 (59.7) | 17 (65.4) | 54 (61.4) |
| Serious | 12 (19.4) | 7 (26.9) | 19 (21.6) |
| Leading to death | 1 (1.6) | 0 (0.0) | 1 (1.1) |
| Leading to treatment discontinuation | 1 (1.6) | 1 (3.8) | 2 (2.3) |
| Leading to dose modification | 45 (72.6) | 21 (80.8) | 66 (75.0) |
| Leading to dose interruption | 42 (67.7) | 21 (80.8) | 63 (71.6) |
| Leading to dose reduction | 40 (64.5) | 17 (65.4) | 57 (64.8) |
| Patients with at least one trTEAE | 61 (98.4) | 26 (100.0) | 87 (98.9) |
| ≥ Grade 3 | 36 (58.1) | 17 (65.4) | 53 (60.2) |
| Serious | 9 (14.5) | 6 (23.1) | 15 (17.0) |
| Leading to death | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Leading to treatment discontinuation | 1 (1.6) | 1 (3.8) | 2 (2.3) |
| Leading to dose modification | 45 (72.6) | 20 (76.9) | 65 (73.9) |
| Leading to dose interruption | 42 (67.7) | 20 (76.9) | 62 (70.5) |
| Leading to dose reduction | 40 (64.5) | 17 (65.4) | 57 (64.8) |
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