Table 2.
Treatment |
Nexvax2 |
Nexvax2 |
Nexvax2 |
Nexvax2 |
Nexvax2 |
Placebo |
---|---|---|---|---|---|---|
Starting dose, μg |
30 |
30 |
3 |
3 |
3 |
|
Maintenance dose, μg |
300 |
300 |
300 |
300 |
900 |
|
Cohort | 1 | 2 | 1 | 2 | 3 | All |
Participants, n | 2 | 4 | 5 | 6 | 10 | 9 |
Participants with any adverse events | 2 (100%) | 4 (100%) | 3 (60%) | 6 (100%) | 9 (90%) | 9 (100%) |
Participants with any drug-related adverse events | 2 (100%) | 4 (100%) | 3 (60%) | 6 (100%) | 7 (70%) | 8 (89%) |
Participants with any adverse events graded at least moderate in severity | 2 (100%) | 3 (75%) | 2 (40%) | 5 (83%) | 6 (60%) | 4 (44%) |
Participants with any adverse events graded at least moderate in severity and drug-related | 1 (50%) | 2 (50%) | 1 (20%) | 4 (67%) | 2 (20%) | 2 (22%) |
Participants who withdrew due to adverse events | 1 (50%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (11%) |
Participants with any serious adverse events | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 2 (22%) |
Adverse events | 34 | 57 | 16 | 56 | 44 | 46 |
Adverse events drug-related | 21 | 45 | 9 | 41 | 20 | 25 |
Adverse events graded at least moderate in severity | 7 | 5 | 3 | 17 | 12 | 7 |
Adverse events graded at least moderate in severity and drug-related | 5 | 2 | 1 | 13 | 2 | 4 |
Adverse events leading to withdrawal | 1 | 0 | 0 | 0 | 0 | 1 |
Serious adverse events | 0 | 0 | 0 | 0 | 0 | 2 |
Data are n (%).