Table 3 Safety summary

From: Sacituzumab govitecan in HR+HER2− metastatic breast cancer: the randomized phase 3 EVER-132-002 trial

TEAEs

SG (n = 165)

Chemotherapy (n = 164)

Any TEAE

165 (100)

164 (100)

 Grade ≥3

135 (82)

114 (70)

TEAEs leading to treatment discontinuation

5 (3)

6 (4)

TEAEs leading to dose interruption

112 (68)

66 (40)

TEAEs leading to dose reduction

42 (25)

53 (32)

TE SAEs

38 (23)

32 (20)

TEAEs leading to death

1 (1)

1 (1)

 Treatment-related

0

0

 

SG (n = 165)

Chemotherapy (n = 164)

Most common TEAEsa

Any grade

Grade ≥ 3

Any grade

Grade ≥ 3

Hematologic TEAEs

 Neutropeniab

145 (88)

114 (69)

128 (78)

101 (62)

 Anemiac

117 (71)

30 (18)

91 (55)

10 (6)

 Leukopeniad

113 (68)

69 (42)

104 (63)

60 (37)

 Thrombocytopeniae

33 (20)

7 (4)

58 (35)

8 (5)

Nonhematologic TEAEs

 Alopecia

103 (62)

0

66 (40)

0

 Nausea

95 (58)

3 (2)

52 (32)

1 (1)

 Diarrhea

84 (51)

11 (7)

22 (13)

0

 Decreased appetite

68 (41)

3 (2)

50 (30)

2 (1)

 Alanine aminotransferase increased

61 (37)

1 (1)

53 (32)

2 (1)

 Vomiting

60 (36)

3 (2)

27 (16)

1 (1)

 Constipation

59 (36)

0

40 (24)

0

 Fatigue

57 (35)

12 (7)

29 (18)

3 (2)

 Aspartate aminotransferase increased

54 (33)

1 (1)

58 (35)

2 (1)

 Hypokalemia

40 (24)

16 (10)

28 (17)

5 (3)

 Hypoalbuminemia

39 (24)

1 (1)

32 (20)

0

 Abdominal pain

36 (22)

1 (1)

17 (10)

1 (1)

 Blood alkaline phosphatase increased

31 (19)

0

43 (26)

1 (1)

 Hyperglycemia

31 (19)

0

35 (21)

1 (1)

 Gamma-glutamyl transferase increased

28 (17)

1 (1)

41 (25)

10 (6)

  1. The data are presented as n (%).
  2. aIncludes any-grade TEAEs observed in at least 20% of patients or grade ≥3 TEAEs observed in at least 10% of patients in either treatment group.
  3. bCombined preferred terms of neutropenia and neutrophil count decreased.
  4. cCombined preferred terms of anemia, red blood cell count decreased and hemoglobin decreased.
  5. dCombined preferred terms of leukopenia and white blood cell count decreased.
  6. eCombined preferred terms of thrombocytopenia and platelet count decreased. TE SAE, treatment-emergent serious adverse event.
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