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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