TROPION-Lung01 Study Design and Baseline demographics
TRAES Occurring in ≥10% of Patients
Dato-DXd
N=297
Docetaxel
N=290
System organ class
Preferred term, n (%)
Blood and lymphatic system
Any grade
Grade ≥3 Any grade
Grade ≥3
Anemia
Neutropeniaª
Gastrointestinal
Stomatitis
43 (15)
11(4)
59 (20)
12(4)
2(1)
76 (26)
11(4)
68 (23)
140 (47)
19(6)
45 (16)
3(1)
Nausea
100 (34)
7(2)
48 (17)
3(1)
Vomiting
38 (13)
3 (1)
22(8)
1 (0.3)
Constipation
29 (10)
0
30 (10)
0
Diarrhea
28 (9)
1 (0.3)
55 (19)
4(1)
General
Asthenia
55 (19)
8 (3)
55 (19)
5(2)
Fatigue
34 (11)
2(1)
40 (14)
6(2)
Metabolism and nutrition
Decreased appetite
68 (23)
1 (0.3)
45 (16)
1 (0.3)
Skin and subcutaneous
Alopecia
95 (32)
0
101 (35)
1 (0.3)b
Rash
36 (12)
0
18 (6)
0
Pruritus
30 (10)
0
12(4)
0
TRAE, treatment-related adverse event.
*This category includes the preferred terms "neutropenia" and "neutrophil count decreased". "Includes an event incorrectly reported as grade 3.
•
Stomatitis and nausea were the most
Daiichi-Sankyo
frequent TRAEs seen with Dato-DXd and
were predominantly grade 1 or 2
Hematologic toxicities, including
neutropenia and febrile neutropenia, were
more common with docetaxel
• No new safety signals were observed with
Dato-DXd
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