Skip to main content

Table 4 Treatment-emergent AE occurring during the study in the safety analysis set

From: CMAB009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients: promising findings from a prospective, open-label, randomized, phase III trial

Parameters

CMAB009 plus irinotecan

(n = 338)

Irinotecan-only

(n = 165)

All grades grade

Grade 3/4

All grades grade

Grade 3/4

n

%

n

%

n

%

n

%

Any drug-related AEa

334

98.8

187

55.3

150

90.9

62

37.6

Diarrhea

134

39.6

35

10.4

59

35.8

12

7.3

Emesis

64

18.9

14

4.1

61

37.0

13

7.9

Leucopenia

169

50.0

54

16.0

65

39.4

15

9.1

Neutropenia

103

30.5

54

16.0

32

19.4

14

8.5

Fatigue

75

22.2

9

2.7

27

16.4

6

3.6

Special AEb

Rash

226

66.9

22

6.5

9

5.5

1

0.6

Paronychia

33

9.8

4

1.2

0

0

0

0.0

Infusion reaction

2

0.6

1

0.3

1

0.6

0

0.0

Hypersensitivity reaction

3

0.9

1

0.3

1c

0.9c

0c

0.0c

  1. AE, adverse events
  2. aIncludes cases having special adverse events
  3. bSpecial adverse events were of categorized based on events that occurred in previous study and were reported for CMAB009 related-toxicities
  4. cSequential-CMAB009 arm (n = 115)
Back to article page

Cancer Communications

ISSN: 2523-3548

Contact us