Summary of complement activation from the Isis Clinical Safety Database
Bb data summary from clinical trials with 14 different 2′-MOE ASOs by subcutaneous administration. ULN is calculated as the mean + 3*S.D. [0.79411 + (3*0.2860) = 1.6521]. Values are the number of subjects (percentage) | total number of subjects.
| Bb Level | Placebo (N = 250) | ASO Treated (N = 767) | |
|---|---|---|---|
| μg/ml | |||
| Overall | Bb > 2× ULN | 11 (4.4) | 250 | 41 (5.3) | 767 |
| Dose <150 mg (2.1 mg/kg) | Bb > 2× ULN | N/A | 25 (7.6) | 327 |
| 150 mg (2.1 mg/kg) ≤ dose ≤ 300 mg (4.3 mg/kg) | Bb > 2× ULN | N/A | 15 (4.9) | 306 |
| Dose >300 mg (4.3 mg/kg) | Bb > 2× ULN | N/A | 1 (0.7) | 134 |
N/A, not applicable.