Table 2 Clinical Adverse Events Considered to Be at Least Possibly or Probably Related to Treatment, at Least of Moderate, Severe or Life-Threatening Intensity, and Occurring in ≥ 2% of Patients in the Safety Population

n (%)

n (%)

Gastrointestinal disorders

Nausea*

18 (22.2)

3 (3.8)

Vomiting NOS

5 (6.2)

0

Diarrhea NOS

4 (4.9)

4 (5.0)

Abdominal pain NOS

2 (2.5)

0

Diarrhea aggravated

2 (2.5)

0

Esophageal reflux

2 (2.5)

0

General disorders

Fatigue

2 (2.5)

4 (5.0)

Dizziness (excluding vertigo)

1 (1.2)

4 (5.0)

Skin and subcutaneous tissue disorders

Dermatitis NOS

1 (1.2)

5 (6.3)

Metabolic and nutritional disorders

Appetite decreased

3 (3.7)

1 (1.3)

Neurologic disorders

Headache NOS

2 (2.5)

2 (2.5)

Insomnia

1 (1.2)

2 (2.5)

Weakness

2 (2.5)

0

Psychiatric disorders

Depression NOS

2 (2.5)

1 (1.3)

Anxiety

1 (1.2)

2 (2.5)

Abnormal dreams

0

2 (2.5)

Vascular disorders

Hypertension NOS

0

2 (2.5)