Table 2 Incidence of TEAEs occurring in at least 10% of the participants in either arm of the safety population at the final analysis

From: Suvemcitug plus chemotherapy in women with platinum-resistant recurrent ovarian cancer: the SCORES randomized, double-blinded, phase 3 trial

 

Suvemcitug plus chemotherapy (n = 281)

Placebo plus chemotherapy (n = 139)

P value*

Preferred term

All grades

Grade ≥3

All grades

Grade ≥3

All grades

Grade ≥3

Any

281 (100)

234 (83.3)

137 (98.6)

92 (66.2)

0.044

<0.001

Neutrophil count decreased

238 (84.7)

140 (49.8)

94 (67.6)

57 (41.0)

<0.001

0.089

White blood cell count decreased

237 (84.3)

101 (35.9)

102 (73.4)

38 (27.3)

0.007

0.078

Anemia

201 (71.5)

47 (16.7)

111 (79.9)

24 (17.3)

0.066

0.890

Platelet count decreased

143 (50.9)

34 (12.1)

43 (30.9)

10 (7.2)

0.001

0.122

Proteinuria

112 (39.9)

11 (3.9)

19 (13.7)

0

<0.001

0.018

Asthenia

97 (34.5)

4 (1.4)

34 (24.5)

4 (2.9)

0.036

0.305

Alanine aminotransferase increased

83 (29.5)

1 (0.4)

24 (17.3)

0

0.007

0.481

Aspartate aminotransferase increased

81 (28.8)

0

26 (18.7)

1 (0.7)

0.025

0.155

Hypertension

79 (28.1)

53 (18.9)

4 (2.9)

1 (0.7)

<0.001

<0.001

Weight decreased

78 (27.8)

7 (2.5)

17 (12.2)

0

<0.001

0.061

Alopecia

72 (25.6)

0

30 (21.6)

0

0.364

-

Nausea

70 (24.9)

1 (0.4)

30 (21.6)

1 (0.7)

0.451

0.611

Vomiting

65 (23.1)

2 (0.7)

25 (18.0)

1 (0.7)

0.227

0.993

Decreased appetite

64 (22.8)

1 (0.4)

24 (17.3)

1 (0.7)

0.192

0.611

Constipation

62 (22.1)

0

25 (18.0)

1 (0.7)

0.332

-

Urinary tract infection

62 (22.1)

5 (1.8)

18 (12.9)

0

0.025

0.114

Hypertriglyceridemia

58 (20.6)

21 (7.5)

12 (8.6)

1 (0.7)

0.002

0.004

Diarrhea

53 (18.9)

3 (1.1)

18 (12.9)

3 (2.2)

0.128

0.375

COVID-19

51 (18.1)

0

14 (10.1)

1 (0.7)

0.031

0.319

Hypoalbuminemia

50 (17.8)

0

18 (12.9)

0

0.205

-

Hypercholesterolemia

49 (17.4)

3 (1.1)

11 (7.9)

0

0.009

0.222

Pyrexia

44 (15.7)

0

15 (10.8)

0

0.177

-

Abdominal pain

43 (15.3)

2 (0.7)

15(10.8)

0

0.207

0.319

Lymphocyte count decreased

42 (14.9)

15 (5.3)

26 (18.7)

7 (5.0)

0.325

0.896

Epistaxis

41 (14.6)

0

0

0

<0.001

-

Hypoesthesia

41 (14.6)

3 (1.1)

21 (15.1)

1 (0.7)

0.888

0.730

Blood creatinine increased

38 (13.5)

0

7 (5.0)

0

0.008

-

Hyperuricemia

37 (13.2)

0

4 (2.9)

0

<0.00

-

Hyponatremia

37 (13.2)

1 (0.4)

13 (9.4)

0

0.256

0.481

Cough

32 (11.4)

1 (0.4)

11 (7.9)

0

0.269

0.481

Stomatitis

30 (10.7)

9 (3.2)

5 (3.6)

2 (1.4)

0.098

0.287

Hyperglycemia

28 (10.0)

0

5 (3.6)

0

0.023

-

Abdominal distension

20 (7.1)

2 (0.7)

14 (10.1)

0

0.296

0.319

Leading to suvemcitug or placebo dose interruption

232 (82.6)

86 (61.9)

-

-

Leading to suvemcitug or placebo dose reduction

26 (9.3)

0

-

-

Leading to discontinuation of suvemcitug or placebo

19 (6.8)

3 (2.2)

-

-

  1. Data are numbers (%) and shown for adverse events that occurred in at least 10% of the participants in either arm during the study intervention or up to 28 days after discontinuation of the intervention. The adverse events were graded according to the NCI CTCAE (v.5.0).
  2. *Two-sided chi-square test; no adjustment for multiple comparisons.
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