Effects of topical timolol for the prevention of radiation-induced dermatitis in breast cancer: a pilot triple-blind, placebo-controlled trial

Table 3 Primary and Secondary Outcomes over time during weeks 1 to 7 for Timolol and 4 Placebo groups

Outcome	Week	Groups		Betwee n groups P-value	Effect of time P-Value	Effect of Time × group P-Value	Overall P-value
		Timolol	Placebo
		Median (IQR)
ARD using RTOG/E ORTC	1	0.0 (0.0)	0.0 (0.0)	1.00	< 0.001	0.341	0.182
	2	0.0 (0.0)	0.0 (0.0)	1.00
	3	0.0 (0.0)	0.0 (0.0)	0.166
	4	1.0 (1.0)	1.0 (1.0)	< 0.001
	5	1.0 (0.0)	1.0 (0.0)	0.001
	6	1.0 (1.0)	2.0 (1.0)	0.013
	¹Follow up	0.0 (1.0)	1.0 (0.0)	0.105
ARD using CTCAE	1	0.0 (0.0)	0.0 (0.0)	1.00	< 0.001	0.341	0.182
	2	0.0 (0.0)	0.0 (0.0)	1.00
	3	0.0 (0.0)	0.0 (0.0)	0.166
	4	1.0 (1.0)	1.0 (1.0)	0.001
	5	1.0 (0.0)	1.0 (0.0)	0.001
	6	1.0 (1.0)	2.0 (1.0)	0.031
	¹Follow up	0.0 (1.0)	1.0 (0.0)	0.105
QOL using Skindex16	1	0.0 (0.0)	0.0 (0.0)	1.00	< 0.001	0.007	0.148
	2	0.0 (0.0)	0.0 (0.0)	1.00
	3	1.0 (2.0)	1.0 (2.0)	0.453
	4	6.0 (7.0)	6.0 (4.0)	0.008
	5	17.0 (3)	17.5 (0.0)	0.001
	6	25.0 (14.0)	40.0 (5.0)	0.014
	¹Follow up	2.0 (13.0)	10.5 (7.0)	0.284

IQR Interquartile range, RTOG/EORTC European organization for research and treatment of cancer, CTCAE Common terminology criteria for adverse events, QOL Quality of life, ¹Follow up is referred to “within 2 weeks after the completion of radiation therapy”; General Linear Model and Mann–Whitney U test was used to compare these values
^*Statistically significant (P-value < 0.05)

ISSN: 1471-2407