Table 1 Summary of treatment-emergent adverse events by frequency and preferred term

Lucerastat 100 mg (n = 6)

Lucerastat 300 mg (n = 6)

Lucerastat 500 mg (n = 6)

Lucerastat 1000 mg (n = 6)

Lucerastat 2 x 1000 mg (n = 6)

Placebo Overall (n = 9)

Lucerastat Overall (n = 24)

Number of subjects with at least one AE

2

2

0

1

4

1

9

Total number of AEs

2

2

0

1

9

1

14

   Fatigue

-

-

-

-

1

-

1

   Influenza like illness

1

-

-

-

-

-

1

   Constipation

-

-

-

1

-

-

1

   Abdominal upper pain

-

-

-

-

1

-

1

   Back pain

-

-

-

-

1

-

1

   Neck stiffness

-

-

-

-

1

-

1

   Cough

-

-

-

-

2

-

2

   Hot flushes

-

-

-

-

-

1

-

   Headache

-

-

-

-

2

-

2

   Paresthesia

1

-

-

-

-

-

1

   Somnolence

-

-

-

-

1

-

1

   Rash NOS

-

2

-

-

-

-

2

Lucerastat 200 mg (n = 6)

Lucerastat 500 mg (n = 12)

Lucerastat 1000 mg (n = 6)

Placebo Overall (n = 13)

Lucerastat Overall (n = 24)

Number of subjects with at least one AE

3

6

1

5

10

Total number of AEs

3

7

3

5

13

   Lymphadenitis submandibular

-

1

-

-

1

   Aphthous stomatitis

-

-

1

-

1

   Constipation

1

-

-

-

1

   Diarrhea

-

1

-

-

1

   Dyspepsia

1

-

-

2

1

   Toothache

1

-

-

-

1

   Nasopharyngitis

-

1

-

-

1

   ALT increased

-

3

-

1

3

   AST increased

-

1

-

-

1

   Dizziness

-

-

-

1

-

   Headache

-

-

1

-

1

   Rash NOS

-

-

1

1

1