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. 2017 Nov 22;26:78–90. doi: 10.1016/j.ebiom.2017.11.018

Table 2.

Overall adverse events summary for participants starting at 3 μg or 30 μg of Nexvax2.

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 (%).