Adverse Event | WHO Toxicity Criteria Grade (All Casualities, N= 31) | |||||
1 | 2 | 3 | 4 | NA | Total | |
Pyrexia | 10 (32.3) | 15 (48.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 25 (80.7) |
Feeling cold | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 23 (74.2) | 23 (74.2) |
Increase in γ -GT | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 12 (38.7) | 12 (38.7) |
Increase in blood pressure | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 10 (32.3) | 10 (32.3) |
Decrease in Hb | 5 (16.1) | 3 (9.7) | 1 (3.2) | 0 (0.0) | 0 (0.0) | 9 (29.0) |
Increase in ALT | 4 (12.9) | 2 (6.5) | 2 (6.5) | 0 (0.0) | 0 (0.0) | 8 (25.9) |
Vomiting NOS | 0 (0.0) | 5 (16.1) | 2 (6.5) | 0 (0.0) | 0 (0.0) | 7 (22.6) |
Pain NOS | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 6 (19.4) | 6 (19.4) |
Decrease in Platelet count | 4 (12.9) | 2 (6.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 6 (19.4) |
Headache NOS | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 6 (19.4) | 6 (19.4) |
Injection site thrombosis | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 5 (16.1) | 5 (16.1) |
Nausea | 5 (16.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 5 (16.1) |
Increase in AST | 3 (9.7) | 0 (0.0) | 0 (0.0) | 2 (6.5) | 0 (0.0) | 5 (16.1) |
Increase in ALP | 4 (12.9) | 0 (0.0) | 1 (3.2) | 0 (0.0) | 0 (0.0) | 5 (16.1) |
Decrease in Blood pressure | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 5 (16.1) | 5 (16.1) |
Feeling hot | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (12.9) | 4 (12.9) |
Dizziness | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (12.9) | 4 (12.9) |
Tachycardia NOS | 4 (12.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (12.9) |
Table 1. Summary of all abnormal reactions (>10%) expressed in Phase 1