Table 2.

Incidence of RT-Related Adverse Events (grade ≥ 1 and ≥ 3)

Adverse Event	% of Patients			P*†	AC-T v AC-T-H*		AC-T v AC-TH-H*
	AC-T (n = 521)	AC-T-H (n = 543)	AC-TH-H (n = 439)		OR	95% CI	OR	95% CI
Grade ≥ 1
Radiation dermatitis	84	84	85	.79	0.97	0.69 to 1.34	1.09	0.76 to 1.55
Pneumonitis or pulmonary infiltrates	0.6	1.1	1.1	.59	1.93	0.48 to 7.75	1.97	0.47 to 8.31
Dyspnea	1.9	2.4	2.3	.86	1.25	0.55 to 2.88	1.18	0.49 to 2.87
Cough	2.9	2.4	2.3	.81	0.83	0.39 to 1.76	0.78	0.35 to 1.75
Radiation dysphagia (esophageal)	1.6	1.5	2.7	.30	0.96	0.36 to 2.58	1.79	0.72 to 4.42
Leukocytes	7.2	12.8	10.3	.01	1.89	1.25 to 2.88	1.47	0.93 to 2.32
Neutrophils or granulocytes	3.7	6.5	5.0	.12	1.81	1.02 to 3.21	1.37	0.73 to 2.57
Grade ≥ 3
Radiation dermatitis	5.6	5.9	4.3	.51	1.06	0.63 to 1.78	0.76	0.42 to 1.38
Pneumonitis or pulmonary infiltrates	—	0.2	—	—	—	—	—	—
Dyspnea	0.6	—	—	—	—	—	—	—
Cough	—	—	—	—	—	—	—	—
Radiation dysphagia (esophageal)	—	—	—	—	—	—	—	—
Leukocytes	0.2	0.6	1.1	.23	2.87	0.30 to 27.69	5.91	0.69 to 50.78
Neutrophils or granulocytes	0.2	—	0.5	.78	—	—	2.35	0.21 to 25.98

Abbreviations: RT, radiotherapy; AC, doxorubicin and cyclophosphamide; H, trastuzumab; T, paclitaxel; OR, odds ratio.

^*Based on a logistic regression model of the given adverse event containing a single predictor variable (arm: AC-T v AC-T-H v AC-TH-H).

^†Wald χ² P value for overall arm effect.