Table 2 Adverse Events of special interest (safety population).
PCD (N = 62) n (%) | PD (N = 60) n (%) | |||||||
|---|---|---|---|---|---|---|---|---|
AE Severity Grade | All | Grade 1-2 | Grade 3-4 | Grade 5 | All | Grade 1-2 | Grade 3-4 | Grade 5 |
Non-Hematologic | ||||||||
Fatigue | 15 (24.2) | 10 (16.1) | 5 (8.1) | 0 | 9 (15.0) | 9 (15.0) | 0 | 0 |
Fever | 9 (14.5) | 5 (8.1) | 3 (4.8) | 1 (1.6) | 7 (11.7) | 5 (8.3) | 2 (3.3) | 0 |
Pneumonia | 8 (12.9) | 0 | 5 (8.1) | 3 (4.8) | 8 (13.3) | 0 | 7 (11.7) | 1 (1.7) |
Constipation | 5 (8.1) | 5 (8.1) | 0 | 0 | 9 (15.0) | 9 (15.0) | 0 | 0 |
Diarrhea | 6 (9.7) | 5 (8.1) | 1 (1.6) | 0 | 2 (3.3) | 1 (1.7) | 1 (1.7) | 0 |
Peripheral Neuropathy | 6 (9.7) | 4 (6.5) | 2 (3.2) | 0 | 2 (3.3) | 1 (1.7) | 1 (1.7) | 0 |
Pulmonary Embolism | 2 (3.2) | 1 (1.6) | 1 (1.6) | 0 | 0 | 0 | 0 | 0 |
Deep Vein Thrombosis | 1 (1.6) | 1 (1.6) | 0 | 0 | 1 (1.7) | 0 | 1 (1.7) | 0 |
Hypersensitivity | 3 (4.8) | 3 (4.8) | 0 | 0 | 2 (3.3) | 2 (3.3) | 0 | 0 |
Hematologic | ||||||||
Anemia | 15 (24.2) | 8 (12.9) | 7 (11.3) | 0 | 10 (16.7) | 4 (6.7) | 6 10.0) | 0 |
Thrombocytopenia | 5 (8.1) | 0 | 5 (8.1) | 0 | 7 (11.7) | 3 (5.0) | 4 (6.7) | 0 |
Neutrophil Count Decreased | 21 (33.9) | 1 (1.6) | 20 (32.3) | 0 | 11 (18.3) | 0 | 11 (18.3) | 0 |
