Table 4 Odds Ratio (All Grade), Target Population: Safety

35 (51.47)

33 (48.5)

Age class 1, year

< 65

3 (60.00)

2 (40.00)

≥65

32 (50.79)

31 (49.20)

0.11–4.40

0.69

0.693

Age class 2, year

< 75

13 (46.43)

15 (53.57)

≥75

22 (55.00)

18 (45.00)

0.53–3.72

1.41

0.487

Baseline weight

< Median

16 (47.06)

18 (52.94)

≥ Median

19 (55.88)

15 (44.12)

0.55–3.70

1.43

0.467

Baseline height

< Median

15 (44.12)

19 (55.88)

≥ Median

20 (58.82)

14 (41.18)

0.69–4.73

1.81

0.227

Body mass index (kg/m²)

<  25

22 (45.83)

26 (54.17)

≥25

13 (65.00)

7 (35.00)

0.75–6.46

2.19

0.154

ECOG PS

0

30 (50.00)

30 (50.00)

1

5 (62.50)

3 (37.50)

0.37–7.61

1.67

0.510

Time from initial diagnosis to first dose

< Median

14 (41.18)

20 (58.82)

≥ Median

21 (61.76)

13 (38.24)

0.87–6.10

2.31

0.092

GS at initial diagnosis

≤ 7

9 (75.00)

3 (25.00)

≥ 8

26 (46.43)

30 (53.57)

0.07–1.18

0.29

0.084

Unknown

0

0

–

–

Baseline PSA

< Median

21 (61.76)

13 (38.24)

≥ Median

14 (41.18)

20 (58.82)

0.16–1.15

0.43

0.092

Baseline Hemoglobin

High

35 (51.47)

33 (48.53)

Normal or Low

0

0

–

–

–

Baseline LDH

High

2 (28.57)

5 (71.43)

0.282

Normal or Low

14 (51.85)

13 (48.15)

0.44–16.37

2.69

Baseline ALP

High

4 (30.77)

9 (69.23)

Normal or Low

31 (56.36)

24 (43.64)

0.80–10.59

2.91

0.106

Previous local treatment

No

21 (47.73)

23 (52.27)

Yes

14 (58.33)

10 (41.67)

0.56–4.19

1.53

0.404

Previous 1st generation AA

No

9 (64.29)

5 (35.71)

Yes

26 (48.15)

28 (51.85)

0.15–1.74

0.52

0.286

Previous chemotherapy

No

35 (51.47)

33 (48.53)

Yes

0

0

–

–

–