Table 2. Adverse events (all grades) reported by ⩾10% of patients overall in any cohort.
|
Dose levels (mg kg−1) |
||||||||
|---|---|---|---|---|---|---|---|---|
| Preferred term (CTCAE v3) number of patients (%) | 0.1 (n=3) | 0.4 (n=3) | 1.0 (n=6) | 2.0 (n=14) | 4.0 (n=3) | 6.0 (n=4) | All AEs/grade 3–4 (n=33) | All ADRs/grade3–4 (n=33) |
| Asthenia | 3 100.0) | 2 (66.7) | 0 (0.0) | 8 (57.1) | 2 (66.7) | 3 (75.0) | 18 (54.5) | 10 (30.3) |
| Condition aggravated | 1 (33.3) | 0 (0.0) | 1 (16.7) | 4 (28.6) | 1 (33.3) | 3 (75.0) | 10 (30.3)/5 (15.2) | |
| Pyrexia | 2 (66.7) | 1 (33.3) | 1 (16.7) | 3 (21.4) | 0 (0.0) | 1 (25.0) | 8 (24.2) | 4 (12.1) |
| Chest pain | 1 (33.3) | 1 (33.3) | 1 (16.7) | 2 (14.3) | 0 (0.0) | 0 (0.0) | 5 (15.2) | |
| Chills | 2 (66.7) | 1 (33.3) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (12.1) | 4 (12.1) |
| General health deterioration | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (14.3) | 1 (33.3) | 1 (25.0) | 4 (12.1)/4 (12.1) | |
| Constipation | 2 (66.7) | 0 (0.0) | 1 (16.7) | 5 (35.7) | 0 (0.0) | 1 (25.0) | 9 (27.3) | |
| Nausea | 0 (0.0) | 1 (33.3) | 1 (16.7) | 3 (21.4) | 2 (66.7) | 1 (25.0) | 8 (24.2) | 5 (15.2) |
| Vomiting | 1 (33.3) | 1 (33.3) | 2 (33.3) | 2 (14.3) | 1 (33.3) | 0 (0.0) | 7 (21.2) | |
| Diarrhoea | 0 (0.0) | 2 (66.7) | 1 (16.7) | 1 (7.1) | 0 (0.0) | 1 (25.0) | 5 (15.2) | |
| Dyspnoea | 2 (66.7) | 1 (33.3) | 3 (50.0) | 5 (35.7) | 0 (0.0) | 3 (75.0) | 14 (42.4)/7 (21.2) | |
| Hyperglycaemia | 0 (0.0) | 0 (0.0) | 1 (16.7) | 3 (21.4) | 2 (66.7) | 2 (50.0) | 8 (24.2)/4 (12.1) | |
| Decreased appetite | 0 (0.0) | 1 (33.3) | 1 (16.7) | 3 (21.4) | 1 (33.3) | 1 (25.0) | 7 (21.2) | |
| Headache | 1 (33.3) | 2 (66.7) | 0 (0.0) | 3 (21.4) | 1 (33.3) | 0 (0.0) | 7 (21.2) | |
| Flushing | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (7.1) | 2 (66.7) | 3 (75.0) | 6 (18.2) | 5 (15.2) |
| Hypersensitivity | 0 (0.0) | 0 (0.0) | 1 (16.7) | 8 (57.1) | 0 (0.0) | 0 (0.0) | 9 (27.3)/5 (15.2) | 9 (27.3)/5 (15.2) |
| Weight decreased | 0 (0.0) | 1 (33.3) | 0 (0.0) | 5 (35.7) | 0 (0.0) | 0 (0.0) | 6 (18.2) | |
Abbreviations: ADR=adverse drug reactions; AE=adverse events; N=number of patients.
A subject with more than one finding in a specific category was only counted once; percentages are based on the total number of subjects in each treatment group. The table is sorted by descending subject count. Infusion reactions related to YS110 treatment were further prevented by corticosteroids premedication.