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Table 3 Any-grade treatment-related AEs occurring in ≥10% of total population and all grade ≥ 3 treatment-related AEs

From: Anti-PD-1 monoclonal antibody MEDI0680 in a phase I study of patients with advanced solid malignancies

  Q3W (mg/kg) Q2W (mg/kg) QW × 2 (mg/kg) QW × 4 (mg/kg) Total
Cohort 1
0.1 (n = 5)
Cohort 2
0.5 (n = 5)
Cohort 3
2.5 (n = 3)
Cohort 4
10 (n = 6)
Cohort 5
20 (n = 9)
Cohort 6
10 (n = 4)
Cohort 7
20 (n = 18)
Cohort 8
20 (n = 3)
Cohort 9
20 (n = 5)
N = 58
Any-grade treatment-related AEa 5 (100) 4 (80) 3 (100) 5 (83) 5 (56) 4 (100) 15 (83) 3 (100) 4 (80) 48 (83)
 Fatigue 0 1 (20) 0 1 (17) 1 (11) 1 (25) 7 (39) 1 (33) 0 12 (21)
 Decreased appetite 2 (40) 1 (20) 2 (67) 1 (17) 0 0 3 (17) 0 0 9 (16)
 Nausea 1 (20) 2 (40) 0 1 (17) 1 (11) 1 (25) 2 (11) 1 (33) 0 9 (16)
 Vomiting 2 (40) 1 (20) 0 0 0 1 (25) 3 (17) 1 (33) 0 8 (14)
 Anemia 0 1 (20) 0 0 1 (11) 0 3 (17) 0 2 (40) 7 (12)
 Arthralgia 0 0 0 0 1 (11) 0 3 (17) 1 (33) 2 (40) 7 (12)
 Pyrexia 1 (20) 1 (20) 0 1 (17) 0 1 (25) 2 (11) 0 1 (20) 7 (12)
 Asthenia 0 1 (20) 0 0 1 (11) 0 4 (22) 0 0 6 (10)
 Pruritus 1 (20) 0 1 (33) 0 1 (11) 0 3 (17) 0 0 6 (10)
Grade ≥ 3 treatment-related AEsa 0 3 (60) 0 0 2 (22) 0 6 (33) 0 1 (20) 12 (20)
 Anemia 0 1 (20) 0 0 1 (11) 0 1 (6) 0 1 (20) 4 (7)
 Fatigue 0 1 (20) 0 0 1 (11) 0 0 0 0 2 (3)
 Aspartate aminotransferase increased 0 1 (20) 0 0 0 0 1 (6) 0 0 2 (3)
 Asthenia 0 0 0 0 1 (11) 0 0 0 0 1 (2)
 Abdominal pain 0 0 0 0 0 0 1 (6) 0 0 1 (2)
 Diarrhea 0 0 0 0 0 0 1 (6) 0 0 1 (2)
 Autoimmune hepatitis 0 1 (20) 0 0 0 0 0 0 0 1 (2)
 Urinary tract infection 0 0 0 0 0 0 1 (6) 0 0 1 (2)
 Alanine aminotransferase increased 0 1 (20) 0 0 0 0 0 0 0 1 (2)
 Blood alkaline phosphatase increased 0 1 (20) 0 0 0 0 0 0 0 1 (2)
 Blood creatine phosphokinase increased 0 0 0 0 0 0 1 (6) 0 0 1 (2)
 Lipase increased 0 0 0 0 1 (11) 0 0 0 0 1 (2)
 Dehydration 0 0 0 0 1 (11) 0 0 0 0 1 (2)
 Hypercalcemia 0 0 0 0 1 (11) 0 0 0 0 1 (2)
 Hyperkalemia 0 0 0 0 0 0 1 (6) 0 0 1 (2)
 Arthralgia 0 0 0 0 0 0 1 (6) 0 0 1 (2)
 Myositis 0 0 0 0 0 0 1 (6) 0 0 1 (2)
 Myasthenia gravis 0 0 0 0 0 0 1 (6) 0 0 1 (2)
 Hypertension 0 0 0 0 0 0 1 (6) 0 0 1 (2)
  1. All grade ≥ 3 events were grade 3, with the exception of two grade 4 events (one event of increased blood creatine phosphokinase and one event of myositis)
  2. Abbreviation: AE adverse event
  3. aPatients were counted once for each category regardless of the number of events