|
Preferred term
|
mITT population (N =82)
|
|---|
|
Grade 1/2
|
Grade 3
|
Grade 4
|
Grade 5
|
All grades
|
|---|
|
Hematologic TEAEs,
n
(%)
|
|
Thrombocytopenia
|
30 (36.6)
|
23 (28.0)
|
19 (23.2)
|
0
|
72 (87.8)
|
|
Anemia
|
24 (29.3)
|
43 (52.4)
|
4 (4.9)
|
0
|
71 (86.6)
|
|
Leukopenia
|
36 (43.9)
|
27 (32.9)
|
5 (6.1)
|
0
|
68 (82.9)
|
|
Lymphopenia
|
28 (34.1)
|
24 (29.3)
|
11 (13.4)
|
0
|
63 (76.8)
|
|
Neutropenia
|
26 (31.7)
|
20 (24.4)
|
13 (15.9)
|
0
|
59 (72.0)
|
|
Non-hematologic TEAEs,
n
(%)
|
|
Nausea
|
58 (70.7)
|
6 (7.3)
|
0
|
0
|
64 (78.0)
|
|
Hyponatremia
|
31 (37.8)
|
24 (29.3)
|
0
|
0
|
55 (67.1)
|
|
Weight decreased
|
54 (65.9)
|
0
|
0
|
0
|
54 (65.9)
|
|
Decreased appetite
|
48 (58.5)
|
3 (3.7)
|
0
|
0
|
51 (62.2)
|
|
Asthenia
|
41 (50.0)
|
8 (9.8)
|
0
|
0
|
49 (59.8)
|
|
Hyperglycemia
|
38 (46.3)
|
7 (8.5)
|
1 (1.2)
|
0
|
46 (56.1)
|
|
Vomiting
|
35 (42.7)
|
6 (7.3)
|
0
|
0
|
41 (50.0)
|
|
Hypocalcemia
|
30 (36.6)
|
5 (6.1)
|
1 (1.2)
|
0
|
36 (43.9)
|
|
Hypokalemia
|
21 (25.6)
|
9 (11.0)
|
1 (1.2)
|
0
|
31 (37.8)
|
|
Hypoalbuminemia
|
25 (30.5)
|
1 (1.2)
|
0
|
0
|
26 (31.7)
|
|
Diarrhea
|
22 (26.8)
|
3 (3.7)
|
0
|
0
|
25 (30.5)
|
|
Lung infection
|
3 (3.7)
|
20 (24.4)
|
1 (1.2)
|
1 (1.2)
|
25 (30.5)
|
|
Hypophosphatemia
|
14 (17.1)
|
5 (6.1)
|
0
|
0
|
19 (23.2)
|
|
Aspartate aminotransferase increased
|
17 (20.7)
|
0
|
2 (2.4)
|
0
|
19 (23.2)
|
|
Alanine aminotransferase increased
|
15 (18.3)
|
2 (2.4)
|
1 (1.2)
|
0
|
18 (22.0)
|
|
Insomnia
|
18 (22.0)
|
0
|
0
|
0
|
18 (22.0)
|
- When multiple adverse events occurred in the same patient, the highest CTCAE grade was used for statistics; when the same patient had multiple adverse events under the same SOC or PT, the highest CTCAE grade was used for statistics
