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Table 2 Overview of treatment-emergent adverse events (safety analysis set)

From: Phase Ib evaluation of a self-adjuvanted protamine formulated mRNA-based active cancer immunotherapy, BI1361849 (CV9202), combined with local radiation treatment in patients with stage IV non-small cell lung cancer

Patients with at least one event, n (%) Stratum 1
(n = 16)
Stratum 2
(n = 8)
Stratum 3
(n = 2)
Overall
(n = 26)
TEAE 16 (100.0) 8 (100.0) 2 (100.0) 26 (100.0)
BI1361849- and/or radiation-related AE 16 (100.0) 8 (100.0) 2 (100.0) 26 (100.0)
 TEAE related to BI1361849 15 (93.8) 8 (100.0) 2 (100.0) 25 (96.2)
 TEAE related to radiation 4 (25.0) 1 (12.5) 0 (50.0) 5 (19.2)
Serious TEAE 7 (43.8) 3 (37.5) 1 (50.0) 11 (42.3)
Serious BI1361849- and/or radiation-related AE 1 (6.3) 0 0 1 (3.8)
 Related to BI1361849 0 0 0 0
 Related to radiation 1 (6.3) 0 0 1 (3.8)
TEAE toxicity grade ≥ 3a 9 (56.3) 4 (50.0) 2 (100.0) 15 (57.7)
BI1361849- and/or radiation-related AE toxicity grade ≥ 3a 2 (12.5) 1 (12.5) 1 (50.0) 4 (15.4)
 Related to BI1361849 1 (6.3) 1 (12.5) 1 (50.0) 3 (11.5)
 Related related to radiation 1 (6.3) 0 0 1 (3.8)
Serious BI1361849- and/or radiation-related AE toxicity grade ≥ 3a 1 (6.3) 0 0 1 (3.8)
 Related to BI1361849 0 0 0 0
 Related to radiation 1 (6.3) 0 0 1 (3.8)
TEAE leading to discontinuation 4 (25.0) 0 0 4 (15.4)
TEAE toxicity grade ≥ 3 leading to discontinuation 2 (12.5) 0 0 2 (7.7)
TEAE leading to interruption/dose modification 4 (25.0) 0 0 4 (15.4)
TEAE leading to death 0 0 0 0
  1. Abbreviations: AE adverse event, TEAE treatment-emergent adverse event
  2. aNational Cancer Institute–Common Terminology Criteria for Adverse Events (NCI-CTCAE) toxicity grading