Table 3 Treatment related adverse events in safety set

From: A multicenter, randomized, double-blind, placebo-controlled phase 3 study of Socazolimab or placebo combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer

 

Any gradeb

 

Grade ≥ 3c

 
 

Socazolimab (n = 249)

Placebo (n = 247)

Socazolimab (n = 249)

Placebo (n = 247)

Any treatment related adverse eventa

246 (98.8)

243 (98.4)

200 (80.3)

187 (75.7)

Decreased neutrophil count

221 (88.8)

224 (90.7)

172 (69.1)

165 (66.8)

leukocytopenia

221 (88.8)

222 (89.9)

110 (44.2)

84 (34.0)

Anemia

212 (85.1)

205 (83.0)

58 (23.3)

51 (20.6)

Decreased platelet count

184 (73.9)

163 (66.0)

84 (33.7)

69 (27.9)

Nausea

79 (31.7)

70 (28.3)

3 (1.2)

4 (1.6)

Increased alanine aminotransferase

61 (24.5)

57 (23.1)

3 (1.2)

0

Increased aspartate aminotransferase

57 (22.9)

44 (17.8)

2 (0.8)

1 (0.4)

Vomiting

45 (18.1)

42 (17.0)

3 (1.2)

2 (0.8)

Constipation

34 (13.7)

38 (15.4)

0

0

Hyponatremia

43 (17.3)

31 (12.6)

12 (4.8)

12 (4.9)

Decreased appetite

43 (17.3)

43 (17.4)

1 (0.4)

0

Asthenia

33 (13.3)

22 (8.9)

2 (0.8)

0

Decreased body weight

32 (12.9)

21 (8.5)

0

0

Hypoalbuminemia

28 (11.2)

23 (9.3)

0

0

Increased alkaline phosphatase

26 (10.4)

17 (6.9)

3 (1.2)

0

Hypothyroidism

25 (10.0)

8 (3.2)

0

0

Decreased lymphocyte count

21 (8.4)

18 (7.3)

8 (3.2)

6 (2.4)

Hypokalemia

18 (7.2)

25 (10.1)

3 (1.2)

7 (2.8)

Infectious pneumonia

15 (6.0)

9 (3.6)

11 (4.4)

6 (2.4)

  1. Data are n (%)
  2. aAdverse events related to socazolimab/placebo, carboplatin or etoposide. Adverse events were graded according to version 5.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events.b. Adverse events related to socazolimab or placebo
  3. bOccurred in 10% or greater of patients in either group
  4. cOccurred in 2% or greater of patients in either group
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