Adverse events >10% (all causes) and serious events (drug related)
| Placebo (n=101) | ISIS 2302 2 mg/kg (n=198) | ISIS 2302 subset: AUC >65 μg×h/ml (n=9) | |
|---|---|---|---|
| *p=0.03, **p<0.0001 versus placebo. | |||
| Vasodilation | 4 (4.0) | 23 (11.6)* | 1 (11.1) |
| Rash | 15 (14.9) | 19 (9.6) | 0 |
| Urticaria | 0 | 6 (3.0) | 0 |
| Anaphylactoid reaction | 0 | 2 (1.0) | 0 |
| Myocardial infarction | 0 | 1 (0.5) | 0 |
| Schwannoma | 0 | 1 (0.5) | 0 |
| Asthenia | 22 (21.8) | 45 (22.7) | 0 |
| Flu syndrome | 12 (11.9) | 27 (13.6) | 1 (11.1) |
| Headache | 26 (25.7) | 65 (32.8) | 1 (11.1) |
| Dizziness | 16 (15.8) | 36 (18.2) | 1 (11.1) |
| Infection | 37 (36.6) | 88 (44.4) | 3 (33.3) |
| Pancreatitis | 1 (1.0) | 0 | 0 |
| Enterocolitis | 26 (25.7) | 44 (22.2) | 2 (22.2) |
| Nausea | 29 (28.7) | 49 (24.7) | 4 (44.4) |
| Vomiting | 12 (11.9) | 28 (14.1) | 2 (22.2) |
| Abdominal pain | 16 (15.8) | 30 (15.2) | 2 (22.2) |
| Average post infusion aPTT increase (s) | 0.8 (4.66) | 8.66 (7.29)** | 8.70 (7.40)** |
| Maximum post infusion aPTT value (s) | 30.4 (7.6) | 41.5 (7.4)** | 42.1 (4.4)** |