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Table 2 Adverse events

From: Safety and in vivo immune assessment of escalating doses of oral laquinimod in patients with RRMS

MS-LAQ-101 % of patients

Preferred term

Pooled placebo

(n = 28)

Laquinimod 0.9 mg

(n = 12)

Laquinimod 1.2 mg

(n = 12)

Laquinimod 1.5 mg

(n = 12)

Laquinimod 1.8 mg

(n = 11)

Laquinimod 2.1 mg

(n = 13)

Laquinimod 2.4 mg

(n = 12)

Laquinimod 2.7 mg

(n = 12)

All

96.4

75

100

83.3

90.9

92.3

100

100

Headache

32.1

50

66.7

41.7

18.2

38.5

91.7

41.7

C-reactive protein increased

7.1

16.7

16.7

8.3

0

7.7

8.3

33.3

Vomiting

0

0

0

8.3

0

7.7

0

33.3

Abdominal pain upper

10.7

0

16.7

8.3

9.1

7.7

33.3

25

Back pain

0

16.7

0

16.7

0

7.7

25

25

Blood fibrinogen increased

0

0

16.7

0

0

7.7

0

25

Myalgia

0

0

0

0

9.1

0

8.3

25

Nausea

7.1

8.3

0

8.3

0

7.7

25

25

Tension headache

0

0

0

0

0

0

0

25

Diarrhea

7.1

8.3

8.3

8.3

9.1

15.4

8.3

16.7

Insomnia

0

0

0

0

0

0

8.3

16.7

Blood creatine Phosphokinase increased

14.3

0

8.3

8.3

18.2

0

0

8.3

Nasopharyngitis

10.7

16.7

33.3

8.3

0

38.5

8.3

8.3

Oropharyngeal pain

0

0

0

0

18.2

0

0

8.3

Pain in extremity

0

8.3

8.3

0

18.2

0

0

8.3

Dizziness

10.7

0

8.3

0

9.1

0

25

0

Contusion

0

0

0

0

0

7.7

16.7

0

  1. Common AEs: AEs reported by at least two patients in any of the laquinimod dose groups and with an incidence higher than the pooled placebo