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Table 5 Most frequent TEAEs (≥5% of patients) in either treatment group across all cycles (safety population)

From: Phase III, randomized, double-blind, placebo-controlled, multicenter study of lipegfilgrastim in patients with non-small cell lung cancer receiving myelosuppressive therapy

AE by preferred term

Placebo (N = 125)

Lipegfilgrastim 6 mg SC (N = 248)

n

%

n

%

Alopecia

42

33.6

101

40.7

Anemia

30

24.0

63

25.4

Nausea

27

21.6

59

23.8

Neutropenia

44

35.2

51

20.6

Thrombocytopenia

10

8.0

32

12.9

Asthenia

23

18.4

28

11.3

Vomiting

15

12.0

28

11.3

Decreased appetite

12

9.6

23

9.3

Hypokalemia

3

2.4

20

8.1

Leukopenia

14

11.2

16

6.5

Fatigue

6

4.8

16

6.5

Disease progression

5

4.0

16

6.5

NSCLC

4

3.2

16

6.5

Chest pain

8

6.4

14

5.6

Febrile neutropenia

10

8.0

11

4.4

Dyspnea

9

7.2

11

4.4

  1. TEAEs include all AEs except those specifically rated by investigators as unrelated to study drug. Multiple mentions per patient are possible. TEAEs with onset after the start of prophylactic open-label lipegfilgrastim treatment are excluded.
  2. AE adverse event, NSCLC non-small cell lung cancer, SC subcutaneously, TEAEs treatment-emergent adverse events.
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