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Table 3 Systemic and local adverse events in 20 patients who received at least one vaccination

From: HPV16 synthetic long peptide (HPV16-SLP) vaccination therapy of patients with advanced or recurrent HPV16-induced gynecological carcinoma, a phase II trial

  Patients (N = 20) Vaccinations (N = 67)
  CTCAE grade 1 CTCAE grade 2 CTCAE grade 3 CTCAE grade 1 CTCAE grade 2 CTCAE grade 3
  <24 h >24 h total <24 h >24 h total <24 h >24 h total <24 h >24 h total <24 h >24 h total <24 h >24 h total
Systemic adverse events
Fever 6 (30%) 1 (5%) 5 (25%) 2 (10%) 1 (5%) 3 (15%) - - - 7 (10.5%) 1 (1.5%) 7 (10.5%) 3 (4.5%) 1 (1.5%) 4 (6%) - - -
Chills/rigors 6 (30%) 1 (5%) 6 (30%) - - - - - - 10 (15%) 1 (1.5%) 11 (16.5%) - - - - - -
Myalgia (yes/no) 0 (0%) 1 (5%) 1 (5%) - - - - - - 0 (0%) 1 (1.5%) 1 (1.5%) - - - - - -
Fatigue 0 (0%) 1 (5%) 1 (5%) 2 (10%) 3 (15%) 3 (15%) - - - 1 (1.5%) 4 (6%) 3 (4.5%) 4 (6%) 4 (6%) 6 (9%) - - -
Nausea 6 (30%) 2 (10%) 6 (30%) - - - - - - 7 (10.5%) 3 (4.5%) 9 (13.5%) - - - - - -
Vomiting 2 (10%) 1 (5%) 2 (10%) - - - - - - 2 (3%) 2 (3%) 3 (4.5%) - - - - - -
Headache - - - 1 (5%) 2 (10%) 2 (10%) - - - 1 (1.5%) 1 (1.5%) 1 (1.5%) 2 (3%) 3 (4.5%) 3 (4.5%) - - -
Rash/Generalised erythema 3 (15%) 1 (5%) 3 (15%) 1 (5%) - 1 (4%) - - - 5 (7.5%) 1 (1.5) 5 (7.5%) 1 (1.5%) - 1 (1.5%) - - -
Inability to concentrate (Y/N) - - - - - - - - - 0 (0%) 0 (0%) 0 (0%) - - - - - -
Tingling extremities 1 (5%) 2 (10%) 2 (10%) - - - - - - 1 (1.5%) 0 (0%) 1 (1.5%) - - - - - -
Swelling extremities 2 (10%) 2 (10%) 4 (20%) - - - - - - 3 (4.5%) 2 (3%) 5 (7.5%) - - - - - -
Flu-like symptoms/Malaise 4 (20%) 3 (15%) 7 (35%) - - - - - - 5 (7.5%) 5 (7.5%) 10 (15%) - - - - - -
Local adverse events
Injection site reaction    0 (0%)    20 (100%)    0 (0%)    0 (0%)    67 (100%)    0(0%)
  1. The number of patients (and percentage) are depicted per catagory (systemically or locally) and grade of toxicity according to CTCAE version 3.