Table 2 Treatment-related adverse events of all grades reported in >20% and of grade 3 or 4 reported in >5% of patients by age.

From: Safety analyses from the phase 3 ASCENT trial of sacituzumab govitecan in metastatic triple-negative breast cancer

TRAE1, n (%)

SG

TPC

<65 years (n = 209)

≥65 years (n = 49)

<65 years (n = 176)

≥65 years (n = 48)

All grades

Grade 3

Grade 4

All grades

Grade 3

Grade 4

All grades

Grade 3

Grade 4

All grades

Grade 3

Grade 4

Hematologic

 Neutropenia2

134 (64)

76 (36)

34 (16)

29 (59)

12 (24)

10 (20)

75 (43)

30 (17)

25 (14)

21 (44)

15 (31)

4 (8)

 Anemia3

63 (30)

13 (6)

0

26 (53)

7 (14)

0

40 (23)

8 (5)

0

14 (29)

3 (6)

0

 Leukopenia4

33 (16)

19 (9)

2 (1)

8 (16)

4 (8)

1 (2)

18 (10)

8 (5)

2 (1)

7 (15)

2 (4)

0

 Febrile neutropenia

11 (5)

10 (5)

1 (<1)

4 (8)

2 (4)

2 (4)

5 (3)

4 (2)

1 (1)

0

0

0

Gastrointestinal

 Diarrhea

121 (58)

22 (11)

0

32 (65)

5 (10)

0

20 (11)

1 (1)

0

7 (15)

0

0

 Nausea

123 (59)

6 (3)

1 (<1)

24 (49)

0

0

48 (27)

0

0

11 (23)

1 (2)

0

 Constipation

32 (15)

0

0

12 (24)

0

0

27 (15)

0

0

5 (10)

0

0

 Vomiting

63 (30)

2 (1)

1 (<1)

12 (24)

0

0

20 (11)

0

0

3 (6)

1 (2)

0

Other

 Fatigue

91 (44)

6 (3)

0

24 (49)

2 (4)

0

49 (28)

10 (6)

0

19 (40)

2 (4)

0

 Alopecia

101 (48)

0

0

18 (37)

0

0

27 (15)

0

0

8 (17)

0

0

 Decreased appetite

40 (19)

2 (1)

0

11 (22)

2 (4)

0

25 (14)

1 (1)

0

7 (15)

0

0

  1. AE adverse event, MedDRA Medical Dictionary for Regulatory Activities, NCI CTCAE National Cancer Institute Common Terminology Criteria for AE, SG sacituzumab govitecan, TPC treatment of physician’s choice, TRAE treatment-related AE.
  2. 1Patients may report more than 1 event per preferred term. AEs were coded using MedDRA v22.1, and AE severity was graded per NCI CTCAE v4.03.
  3. 2Combined preferred terms of “neutropenia” and “neutrophil count decreased.”
  4. 3Combined preferred terms of “anemia”, “hemoglobin decreased”, and “red blood cell count decreased.”
  5. 4Combined preferred terms of “leukopenia” and “white blood cell count decreased.”