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) |