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Randomized, Double-Blind, Placebo-Controlled Trial of MUC1 Vaccine in Patients with Newly Diagnosed Advanced Adenomas

Enrollment Statistics

Target Enrollment: 120

Actual Enrollment: 130

Actual Registration: 130

  • 110 people randomized
    • 54 in Arm I (54 out of 110 randomized): MUC1 Vaccine
      • 48 completed the study.
      • 2 withdrew from study.
      • 3 lost to follow-up.
      • 1 dropped due to other reasons.
    • 56 in Arm II (56 out of 110 randomized): Placebo
      • 46 completed the study
      • 5 withdrew from study.
      • 1 dropped due to adverse event.
      • 2 lost to follow-up.
      • 2 dropped due to other reasons.
  • 20 people were not randomized (20 of 130 registered)

Statistical Analysis and Total Study Population Demographics:

  • Age (years):
    • Mean: 59.3
    • Range: 40-70
    • Median: 59
  • Height (cm):
    • Mean: 172
    • IQR: 165-180
    • Range: 149-191
    • Median: 173
  • Weight (kg):
    • Mean: 90
    • IQR: 77-101
    • Range: 53-150
    • Median: 173
  • Gender:
    • Male: 71 (64.6%)
    • Female: 39 (35.4%)