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Table 2 Percentages of galcanezumab- versus placebo-treated patients who shifted from CM to EM frequency

From: Shift from chronic to episodic migraine frequency in a long-term phase 3 study of galcanezumab

Group

N

Shifted at Month 3

Shifted at All 3 Months

 

n

Raw %

Model estimated % (SE)

(95% CI)

OR (95% CI)

vs. Placebo

P vs. Placebo

n

Raw %

Model estimated % (SE)

(95% CI)

OR (95% CI)

vs. Placebo

P vs. Placebo

 

Shift to EM frequency

Placebo

511

216

42.3

39.7 (2.7)

(34.5, 45.1)

  

101

19.8

16.7 (1.8)

(13.5, 20.4)

   

Galcanezumab 120 mg

263

147

55.9

53.9 (3.6)

(46.8, 60.9)

1.8

(1.3, 2.5)

< 0.001

90

34.2

29.9 (3)

(24.3, 36.2)

2.1

(1.5, 3)

< 0.001

 

Galcanezumab 240 mg

267

134

50.2

47.1 (3.6)

(40.1, 54.2)

1.4

(1.0, 1.9)

0.065

77

28.8

24.3 (2.8)

(19.3, 30.1)

1.6

(1.1, 2.3)

0.008

 

Galcanezumab pooled

530

281

53.0

50.5 (2.8)

(45.1, 55.9)

1.6

(1.2, 2.0)

0.001

167

31.5

27.1 (2.2)

(22.9, 31.6)

1.9

(1.4, 2.5)

< 0.001

 

Shift to LFEM frequency

Placebo

511

111

21.7

17.8 (2.0)

(14.1, 22.1)

  

28

5.5

4.3 (0.8)

(3.0, 6.2)

   

Galcanezumab 120 mg

263

77

29.3

24.7 (3.0)

(19.3, 31.2)

1.5

(1.1, 2.2)

0.023

32

12.2

9.8 (1.7)

(7, 13.6)

2.4

(1.5, 3.9)

< 0.001

 

Galcanezumab 240 mg

267

85

31.8

26.8 (3.2)

(21.1, 33.5)

1.7

(1.2, 2.4)

0.004

36

13.5

10.6 (1.7)

(7.7, 14.5)

2.6

(1.6, 4.2)

< 0.001

 

Galcanezumab pooled

530

162

30.6

25.8 (2.4)

(21.3, 30.8)

1.6

(1.2, 2.2)

0.002

68

12.8

10.2 (1.3)

(7.9, 13.1)

2.5

(1.7, 3.8)

< 0.001

 

Shift to VLFEM frequency

Placebo

511

45

8.8

6.5 (1.3)

(4.4, 9.5)

  

9

1.8

1.4 (0.5)

(0.8, 2.7)

   

Galcanezumab 120 mg

263

29

11.0

7.7 (1.8)

(4.9, 12.0)

1.2

(0.7, 2.0)

0.46

5

1.9

1.5 (0.6)

(0.7, 3.5)

1.1

(0.4, 2.9)

0.912

 

Galcanezumab 240 mg

267

39

14.6

10.6 (2.2)

(7.1, 15.7)

1.7

(1.1, 2.8)

0.025

8

3

2.2 (0.8)

(1.1, 4.3)

1.6

(0.7, 3.8)

0.318

 

Galcanezumab pooled

530

68

12.8

9.2 (1.6)

(6.5, 12.9)

1.5

(1, 2.2)

0.069

13

2.5

1.9 (0.5)

(1.1, 3.2)

1.3

(0.6, 2.8)

0.487

 
  1. Abbreviations: CI, confidence interval; CM, chronic migraine; EM, episodic migraine, LFEM, low frequency episodic migraine; OR, odds ratio; SD, standard deviation; SE, standard error, VLFEM, very low frequency episodic migraine
  2. Note: EM is defined as < 8 migraine headache days/month or < 15 headache days/month, LFEM as < 8 migraine headache days/month; and VLFEM as < 4 migraine headache days/month. Thus, EM includes LFEM and VLFEM, and LFEM includes VLFEM