. Author manuscript; available in PMC: 2021 Sep 1.

Published in final edited form as: J Thorac Oncol. 2020 Apr 27;15(9):1425–1433. doi: 10.1016/j.jtho.2020.04.020

Table 3:

Threshold for reporting AE any grade (n=209)

Number of patients with AE	Number of trials with AE any grade by threshold	Association with trial size and phase (OR, 95% CI)^*
Number of patients with AE	Number of trials with AE any grade by threshold	Phase II vs I	Trial size ≥40 vs <40
1-2 patients	46 (22%)	-	-
5-10% incidence	66 (32%)	−.3 (−1.0-0.5)	1.6 (0.7-2.4)
15-20% incidence	30 (14%)	0.6 (−0.3-1.6)	2.0 (0.9-3.0)
>=25% incidence	5 (2%)	−15 (−1713-1684)	0.9 (−1.0-2.8)
Not reported	62 (30%)^*	0.3 (−0.5-1.0)	1.2 (0.4-2.1)
Total	209

Bold indiates p<0.05