Table 2.
Group 1 N=16 |
Group 2 N=16 |
Group 3 N=12 |
Total N=44 |
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---|---|---|---|---|---|---|---|---|---|---|
Maximum Toxicity Grade |
Maximum Toxicity Grade |
Maximum Toxicity Grade |
Subjects with Related Adverse Events (%) |
|||||||
1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | ||
General Disorders and Administration Site Conditions | ||||||||||
Injection Site Pain | 7 | 2 | 1 | 10 | 4 | 0 | 4 | 8 | 0 | 36 (82) |
Malaise | 4 | 1 | 0 | 5 | 1 | 0 | 5 | 2 | 0 | 18 (41) |
Feeling Hot and Cold | 1 | 1 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 5 (11) |
Injection Site Induration | 0 | 0 | 0 | 3 | 0 | 0 | 2 | 0 | 0 | 5 (11) |
Fatigue | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 (7) |
Injection Site Erythema | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 3 (7) |
Injection Site Pruritis | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 3 (7) |
Pyrexia | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 3 (7) |
Feeling Hot | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (5) |
Injection Site Swelling | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 2 (5) |
Rigors | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 2 (5) |
Musculoskeletal and Connective Tissue | ||||||||||
Myalgia | 3 | 3 | 0 | 8 | 3 | 0 | 6 | 1 | 0 | 24 (55) |
Nervous system | ||||||||||
Headache | 5 | 1 | 0 | 7 | 0 | 0 | 5 | 0 | 0 | 18 (41) |
Gastrointestinal | ||||||||||
Nausea | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 3 (7) |
Skin and Subcutaneous Tissue Disorders | ||||||||||
Erythema | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 2 (5) |
Pruritis | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 (5) |
Rash | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 (5) |
Investigations | ||||||||||
Haemoglobin Decreased | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 (5) |
No Toxicity Grade 4 related adverse events were reported
Subjects may have had more than one occurrence of the same event, however only one occurrence was counted per subject.