Table 5.

Central radiology assessment by combined X rays and CT scans on radiologic lung changes suggestive of pneumonitis

	Japanese subgroup, n (%)		Overall population, n (%)
	Everolimus (n = 23)	Placebo (n = 17)	Everolimus (n = 204)	Placebo (n = 203)
Patients with radiologic lung changes suggestive of pneumonitis
Baseline	1 (4.3)	0	15 (7.4)	10 (4.9)
Post-baselinea	7 (30.4)	0	68 (33.3)	27 (13.3)
Newly occurring or worsenedb	7 (30.4)	0	62 (30.4)	23 (11.3)
Without review	0	0	1 (0.5)	2 (1.0)
Pulmonary adverse events in patients with newly occurring or worsened lung changes suggestive of pneumonitis
Total	7 (30.4)	0	27 (13.2)	0
Pneumonitis	5 (21.7)	0	19 (9.3)	0
Interstitial lung disease	2 (8.7)	0	4 (2.0)	0
Lung infiltration	0	0	5 (2.5)	0
Pulmonary fibrosis	0	0	1 (0.5)	0

CT, computed tomography.

^aNumber of patients with any evidence of pneumonitis at any post-baseline assessment regardless of the baseline status.

^bNumber of patients with newly occurring or worsened pneumonitis compared with baseline.