Table 2 Summary of TEAEs (safety analysis set).

From: A phase I study of ATR inhibitor gartisertib (M4344) as a single agent and in combination with carboplatin in patients with advanced solid tumours

Safety outcomes, n (%)

Cohort A (N = 42)

Cohort A2 (N = 26)

Cohort B1 (N = 16)

Cohort C (N = 13)

Any TEAE

42 (100.0)

26 (100.0)

16 (100.0)

13 (100.0)

 Grade ≥3

28 (66.7)

19 (73.1)

15 (93.8)

10 (76.9)

 Grade ≥4

3 (7.1)

2 (7.7)

9 (56.3)

4 (30.8)

Any trial drug-related TEAE (gartisertib or carboplatin)

–

–

16 (100.0)

–

 Grade ≥3

14 (87.5)

 Grade ≥4

7 (43.8)

Gartisertib-related TEAE

39 (92.9)

24 (92.3)

16 (100.0)

13 (100.0)

 Grade ≥3

20 (47.6)

15 (57.7)

13 (81.3)

8 (61.5)

 Grade ≥4

1 (2.4)

1 (3.8)

7 (43.8)

0 (0.0)

Carboplatin-related TEAE

–

–

16 (100)

–

 Grade ≥3

12 (75.0)

 Grade ≥4

7 (43.8)

Any serious TEAE

21 (50.0)

13 (50.0)

8 (50.0)

7 (53.8)

 Gartisertib-related serious TEAE

8 (19.0)

6 (23.1)

6 (37.5)

2 (15.4)

 Carboplatin-related serious TEAE

–

–

5 (31.3)

–

  1. TEAE treatment-emergent adverse event.
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