Table 2 Adverse events
Patients in population | Two doses of V935 (low dose) | Three doses of V934 and two doses of V935 (low dose) | Two doses of V935 (high dose) | Three doses of V934 and two doses of V935 (high dose) | Five doses of V934 and two doses of V935 (high dose) | Total |
|---|---|---|---|---|---|---|
n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | |
With follow-up | 3 (100.0) | 3 (100.0) | 10 (100.0) | 11 (100.0) | 10 (100.0) | 37 (100.0) |
With one or more adverse events | 3 (100.0) | 3 (100.0) | 8 (80.0) | 11 (100.0) | 10 (100.0) | 35 (94.6) |
Injection-site | 1 (33.3) | 2 (66.7) | 3 (30.0) | 10 (90.9) | 10 (100.0) | 26 (70.3) |
Non-injection-site | 3 (100.0) | 2 (66.7) | 8 (80.0) | 10 (90.9) | 10 (100.0) | 33 (89.2) |
With no adverse event | 0 (0.0) | 0 (0.0) | 2 (20.0) | 0 (0.0) | 0 (0.0) | 2 (5.4) |
With vaccine-relateda adverse events | 2 (66.7) | 3 (100.0) | 4 (40.0) | 11 (100.0) | 10 (100.0) | 30 (81.1) |
Injection site | 1 (33.3) | 2 (66.7) | 3 (30.0) | 10 (90.9) | 10 (100.0) | 26 (70.3) |
Non-injection site | 1 (33.3) | 1 (33.3) | 1 (10.0) | 5 (45.5) | 5 (50.0) | 13 (35.1) |
With serious adverse events | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (18.2) | 1 (10.0) | 3 (8.1) |
With serious vaccine-related adverse events | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Who died | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Discontinuedb due to an adverse event | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Discontinued due to a vaccine-related adverse event | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Discontinued due to a serious adverse event | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Discontinued due to a serious vaccine-related adverse event | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |