Table 3. Distribution of subjects with at least 1 TEAE to dose steps.
| Dose group | Subjects treated | Overall | TEAE maximum intensity | ||
|---|---|---|---|---|---|
| Mild | Moderate | Severe | |||
| Subj. with TEAE % in group |
Affected subj. % of affected % of treated |
Affected subj. % of affected % of treated |
Affected subj. % of affected % of treated |
||
| Total | 496 | 293 59.1% |
269 91.8% 54.2% |
23 7.8% 4.6% |
1 0.3% 0.2% |
| Active drug | 370 | 231 62.4% |
213 92.2% 57.6% |
18 7.8% 4.9% |
0 |
| Placebo | 126 | 62 49.2% |
56 90.3% 44.4% |
5 8.1% 4.0% |
1 1.6% 0.8% |
| Dose step 1 | 101 | 54 53.5% |
48 88.9% 47.5% |
6 11.1% 5.9% |
0 |
| Dose step 2 | 101 | 65 64.4% |
63 96.9% 62.4% |
2 3.1% 2.0% |
0 |
| Dose step 3 | 100 | 65 65.0% |
56 86.2% 56.0% |
9 13.8% 9.0% |
0 |
| Dose step 4 | 59 | 44 74.6% |
43 97.7% 72.9% |
1 2.3% 1.7% |
0 |
| Dose step 5 | 9 | 3 33.3% |
3 100% 33.3% |
0 | 0 |
TEAE = treatment-emergent adverse events.