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Table 2 Adverse events

From: Safety, tolerability and immunogenicity of V934/V935 hTERT vaccination in cancer patients with selected solid tumors: a phase I study

Patients in populationTwo 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-up3 (100.0)3 (100.0)10 (100.0)11 (100.0)10 (100.0)37 (100.0)
With one or more adverse events3 (100.0)3 (100.0)8 (80.0)11 (100.0)10 (100.0)35 (94.6)
Injection-site1 (33.3)2 (66.7)3 (30.0)10 (90.9)10 (100.0)26 (70.3)
Non-injection-site3 (100.0)2 (66.7)8 (80.0)10 (90.9)10 (100.0)33 (89.2)
With no adverse event0 (0.0)0 (0.0)2 (20.0)0 (0.0)0 (0.0)2 (5.4)
With vaccine-relateda adverse events2 (66.7)3 (100.0)4 (40.0)11 (100.0)10 (100.0)30 (81.1)
Injection site1 (33.3)2 (66.7)3 (30.0)10 (90.9)10 (100.0)26 (70.3)
Non-injection site1 (33.3)1 (33.3)1 (10.0)5 (45.5)5 (50.0)13 (35.1)
With serious adverse events0 (0.0)0 (0.0)0 (0.0)2 (18.2)1 (10.0)3 (8.1)
With serious vaccine-related adverse events0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
Who died0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
Discontinuedb due to an adverse event0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
Discontinued due to a vaccine-related adverse event0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
Discontinued due to a serious adverse event0 (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 event0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
  1. aDetermined by the investigator to be related to the vaccine
  2. bStudy medication withdrawn