TABLE 3.
Arm A: (n = 3) | Arm B: (n = 3) | Arm C: (n = 6) | Arm D: (n = 5) | |||||
---|---|---|---|---|---|---|---|---|
Category/adverse event | All grade (%) | Grade 3/4 (%) | All grade (%) | Grade 3/4 (%) | All grade (%) | Grade 3/4 (%) | All grade (%) | Grade 3/4 (%) |
AE patients | 3 (100.0) | 2 (66.7) | 3 (100.0) | 3 (100.0) | 6 (100.0) | 4 (66.7) | 5 (100.0) | 3 (60.0) |
Constitutional | ||||||||
Fever | 1 (33.3) | 0 |
2 (66.7) |
0 |
3 (50.0) |
0 | 1 (20.0) | 0 |
Fatigue | 0 | 0 |
3 (66.7) |
0 |
2 (33.3) |
0 | 1 (20.0) | 0 |
Edema peripheral | 0 | 0 |
1 (33.3) |
0 |
2 (33.3) |
0 | 2 (40.0) | 0 |
Loss of appetite | 1 (33.3) | 0 |
1 (33.3) |
1 (33.3) |
2 (33.3) |
0 | 1 (20.0) | 0 |
Hematological/laboratory | ||||||||
Leucopenia | 2 (66.7) | 1 (33.3) | 3 (100.0) |
1 (33.3) |
4 (66.7) |
3 (50.0) | 4 (80.0) | 0 |
Neutropenia | 3 (100.0) | 2 (66.7) | 2 (66.7) |
1 (33.3) |
4 (66.7) |
2 (33.3) | 4 (80.0) | 1 (20.0) |
Thrombocytopenia | 1 (33.3) | 1 (33.3) | 2 (66.7) |
1 (33.3) |
5 (83.3) |
1 (16.7) | 3 (60.0) | 1 (20.0) |
Anemia | 2 (66.7) | 1 (33.3) | 3 (100.0) |
1 (33.3) |
5 (83.3%) | 0 | 4 (80.0) | 1 (20.0) |
Aspartate Aminotransferase high |
0 | 0 | 3 (100.0) | 0 |
3 (50.0) |
0 | 0 | 0 |
Glutamic‐pyruvic transaminase high | 1 (33.3) | 0 | 3 (100.0) | 0 |
1 (16.7) |
0 | 1 (20.0) | 0 |
Alkaline phosphatase high | 1 (33.3) | 0 |
2 (66.7) |
0 |
3 (50.0) |
0 | 1 (20.0) | 0 |
D‐dimer high | 1 (33.3) | 0 |
1 (33.3) |
0 |
1 (16.7) |
0 | 1 (20.0) | 0 |
Gastrointestinal | ||||||||
Nausea | 0 | 0 |
1 (33.3) |
0 |
2 (33.3) |
0 | 0 | 0 |
Vomiting | 1 (33.3) | 0 |
1 (33.3) |
0 |
3 (50.0) |
0 | 1 (20.0) | 0 |
Oral mucositis | 0 | 0 | 0 | 0 |
1 (16.7) |
0 | 0 | 0 |
Diarrhea | 0 | 0 |
1 (33.3) |
0 | 0 | 0 | 3 (60.0) | 0 |
Abdominal pain | 0 | 0 |
1 (33.3) |
0 |
2 (33.3) |
0 | 0 | 0 |
Constipation | 0 | 0 | 0 | 0 |
3 (50.0) |
0 | 1 (30.0) | 0 |
Ascitic fluid | 1 (33.3) | |||||||
Other adverse events | ||||||||
Sinus bradycardia | 0 | 0 | 0 | 0 |
4 (66.7) |
0 | 1 (20.0) | 0 |
Palpitation | 0 | 0 | 0 | 0 |
2 (33.3) |
0 | 0 | 0 |
Chest distress | 0 | 0 | 0 | 0 |
4 (66.7) |
0 | 0 | 0 |
Deep venous thrombosis | 1 (33.3) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Rash | 1 (33.3) | 0 |
1 (33.3) |
2 (33.3) |
2 (33.3) |
0 |
1 (20.0) | 0 |
Interstitial lung disease | 0 | 0 | 0 |
2 (33.3) |
2 (33.3) |
0 | 0 | 0 |
Splenic infarction | 0 | 0 | 0 | 0 |
1 (16.7) |
0 | 0 | 0 |