Table 4.
AEs of special interest (safety analysis set).
| All Grades | All patients (N = 3246) | CNS metastasis (n = 51) | Prior chemotherapy (n = 194) | ECOG PS 2 (n = 112) | VM + prior chemotherapy (n = 146) | VM + ECOG PS 2 (n = 77) |
|---|---|---|---|---|---|---|
| Neutropeniaa | 2417 (74.5) | 34 (66.7) | 145 (74.7) | 72 (64.3) | 106 (72.6) | 48 (62.3) |
| ALT increased | 526 (16.2) | 10 (19.6) | 27 (13.9) | 18 (16.1) | 19 (13.0) | 12 (15.6) |
| AST increase | 459 (14.1) | 8 (15.7) | 20 (10.3) | 12 (10.7) | 15 (10.3) | 9 (11.7) |
| QTcF interval prolongation |
217 (6.7) |
3 (5.9) |
14 (7.2) |
14 (12.5) |
9 (6.2) |
11 (14.3) |
| Grade ≥3 |
All patients (N = 3246) |
CNS metastasis (n = 51) |
Prior chemotherapy (n = 194) |
ECOG PS 2 (n = 112) |
VM + prior chemotherapy (n = 146) |
VM + ECOG PS 2 (n = 77) |
| Neutropeniaa | 1856 (57.2) | 26 (51.0) | 104 (53.6) | 57 (50.9) | 77 (52.7) | 35 (45.5) |
| ALT increased | 249 (7.7) | 3 (5.9) | 13 (6.7) | 6 (5.4) | 9 (6.2) | 4 (5.2) |
| AST increase | 184 (5.7) | 3 (5.9) | 9 (4.6) | 5 (4.5) | 7 (4.8) | 4 (5.2) |
| QTcF interval prolongation | 33 (1.0) | 0 | 4 (2.1) | 4 (3.6) | 3 (2.1) | 3 (3.9) |
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CNS, central nervous system; ECOG PS, Eastern Cooperative Oncology Group performance status; QTcF, QT interval corrected by Fridericia's formula; VM, visceral metastases.
Numbers (n) represent counts of patients. A patient with multiple severity grades for an AE was only counted under the maximum grade.
a
Includes “neutropenia” and “neutrophil count decreased.”