Table 3.

Adverse event and grading for individuals in the CC-486 arm that received at least one dose of medication

Adverse Event Type	Grade 1 # events (# patients)	Grade 2# events (# patients)	Grade 3# events (# patients)	Grade 4# events (# patients)	Any Grade# events (# patients)
Summary for each grade
Counts	76 (23)	25 (12)	9 (4)	5 (3)	115 (23)
Events/month*	0.49	0.16	0.06	0.03	0.75
Summary by AE type
Constitutional
Appetite/weight loss	12 (11)	0	0	0	12 (11)
Dizziness	3 (3)	0	0	0	3 (3)
Fatigue	11 (10)	6 (6)	0	0	17 (13)
Headache	1 (1)	0	0	0	1 (1)
Gastrointestinal			0	0
Abdominal Discomfort/Bloating	3 (3)	1 (1)	0	0	4 (4)
Constipation	2 (2)	1 (1)	0	0	3 (3)
Diarrhea	12 (10)	1 (1)	2 (1)	0	15 (10)
Nausea	17 (12)	4 (2)	0	0	21 (13)
Dyspepsia	1 (1)	0	0	0	1 (1)
Flatulence	3 (3)	0	0	0	3 (3)
Vomiting	2 (2)	2 (2)	0	0	4 (3)
Hematologic
Anemia	3 (3)	2 (2)	2 (1)	0	7 (5)
Leukopenia	1 (1)	4 (4)	3 (3)	1 (1)	9 (6)
Lymphocytopenia	0 (0)	0 (1)	1 (1)	0 (0)	1 (1)
Neutropenia	0	2 (2)	1 (1)	4 (3)	7 (5)
Thrombocytopenia	1 (1)	2 (1)	0	0	3 (1)
Other
Fever	1 (1)	0	0	0	1 (1)
Hyperglycemia	1 (1)	0	0	0	1 (1)
Muscle cramps	1 (1)	0	0	0	1 (1)
Oral abscess	1 (1)	0	0	0	1 (1)

*Rate per month is based upon a total follow-up of 153.7 months across all patients