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Table 2 Grade 1 or 2 adverse events occurring in at least 2 patients

From: Phase 1 studies of the safety and immunogenicity of electroporated HER2/CEA DNA vaccine followed by adenoviral boost immunization in patients with solid tumors

Adverse event, n (%) Study 1 Study 2a
  V930 DNA-EPb V930 DNA-EPb V932 Adc V932 Adc
  0.25 mg 2.5 mg 0.5 × 109 0.5 × 1011
    vg/injection vg/injection
  (n=6) (n=22) (n=6) (n=5)
Diarrhea 2 (33) 5 (23) 0 0
Fatigue 1 (17) 5 (23) 1 (17) 1 (20)
Arthralgias 1 (17) 3 (14) 2 (33) 0
Nausea 0 4 (18) 0 0
Skin & subcutaneous tissue disorders 1 (17) 3 (14) 1 (17) 1 (20)
Abdominal pain 0 3a (14) 0 0
Infections 0 3 (14) 1 (17) 0
Insomnia 1 (17) 2 (9) 0 0
Constipation 0 2 (9) 0 0
Dizziness 0 2 (9) 1 (17) 0
Dyspnea 0 4 (18) 1 (17) 0
Hot flushes 0 2 (9) 0 0
Musculoskeletal pain 0 2 (9) 4 (67) 4b (80)
Vomiting 0 2 (9) 0 0
Creatinine elevation (grade 1) 0 1 (5) 0 2 (40)
  1. aSix eligible patients from Study 1 were enrolled into Study 2. Therefore, only 5 patients that had not previously participated in Study 1 were enrolled into Study 2. Overall 33 patients (not 39) were enrolled in both studies.
  2. bAll adverse events with DNA vaccine alone (V930 DNA-EP) were Grade 1-2, with the exception of one case of grade 3 abdominal pain felt to be unrelated to study drug in the treatment phase and one case of grade 3 abdominal pain due to small bowel obstruction in the follow-up phase believed to be related to the tumor and not related to study drug.
  3. cAll averse events with V930 DNA-EP→V932Ad were grades 1 or 2, with the exception of one patient who experienced grade 3 muscle spasm in the low-dose V932 Ad group and one patient with ankle pain and unilateral leg pain in the high-dose V932Ad group. Both were not related to the study drug, as determined by the investigator.