Table 2.
Time course of adverse events (AEs) utilizing multiple increasing doses of custirsen (group B only)
| Day 2 | Day 4 | Day 6 | Day 8 | |
|---|---|---|---|---|
| n (%) | 320 mg(n =12) | 480 mg(n =12) | 640 mg(n =11) | 640 mg(n =11) |
| Subjects with at least one AE* | 5 (42) | 6 (50) | 4 (36) | 11 (100) |
| Constitutional AEs | ||||
| Myalgia | 4 (33) | 4 (33) | 0 | 0 |
| Chills | 2 (17) | 2 (17) | 0 | 0 |
| Fatigue | 1 (8) | 0 | 0 | 0 |
| Pyrexia | 1 (8) | 2 (17) | 0 | 0 |
| Dizziness | 1 (8) | 0 | 0 | 0 |
| Headache | 1 (8) | 3 (25) | 1 (9) | 0 |
| Flushing | 0 | 1 (8) | 0 | 0 |
| Other AEs | ||||
| Activated partial thromboplastin time prolonged | 0 | 0 | 0 | 11 (100) |
| Alanine aminotransferase increased | 0 | 0 | 3 (27) | 0 |
| Aspartate aminotransferase increased | 0 | 0 | 1 (9) | 0 |
| Gamma glutamyl transferase increased | 0 | 0 | 1 (9) | 0 |
| Muscle spasms | 0 | 1 (8) | 0 | 0 |
| Eye pain | 0 | 1 (8) | 0 | 0 |
| Blurred vision | 1 (8) | 0 | 0 | 0 |
Events with onset on or after first dose of study drug (on-study events). All events listed according to MedDRA Version 15.0 preferred term.