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Table 2 Safety summary in the as-treated population

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

Event, n (%)a 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 AE 5 (100) 5 (100) 3 (100) 6 (100) 9 (100) 4 (100) 18 (100) 3 (100) 5 (100) 58 (100)
Any grade ≥ 3 AE 2 (40) 5 (100) 1 (33) 5 (83) 6 (67) 2 (50) 11 (61) 1 (33) 1 (20) 34 (59)
Any death (grade 5 AE) 1 (20) 0 0 1 (17) 0 0 2 (11) 0 0 4 (7)
Serious AE 2 (40) 4 (80) 0 3 (50) 5 (56) 1 (25) 10 (56) 1 (33) 2 (40) 28 (48)
AE leading to discontinuation 1 (20) 2 (40) 0 1 (17) 2 (22) 0 2 (11) 0 0 8 (14)
Treatment-related AE 5 (100) 4 (80) 3 (100) 5 (83) 5 (56) 4 (100) 15 (83) 3 (100) 4 (80) 48 (83)
Treatment-related grade ≥ 3 AE 0 3 (60) 0 0 2 (22) 0 6 (33) 0 1 (20) 12 (21)
Treatment-related death 0 0 0 0 0 0 0 0 0 0
Treatment-related serious AE 0 1 (20) 0 1 (17) 1 (11) 1 (25) 3 (17) 0 1 (20) 8 (14)
Treatment-related AE leading to discontinuation 0 2 (40) 0 1 (17) 1 (11) 0 0 0 0 4 (7)
  1. Abbreviation: AE adverse event
  2. aPatients were counted once for each category regardless of the number of events