Table 1.

Summary of prespecified exploratory bone endpoints

Exploratory endpoint	Description
Time to first bone metastasis	Determined by the time from randomization to the first observation of bone metastasis as site of first or subsequent disease recurrence, excluding death
Time to bone metastasis as site of first recurrence	Determined by the time from randomization to the first observation of bone metastasis as site of first disease recurrence, excluding death
Time to first symptomatic bone metastasis	Determined by the time from randomization to the first observation of bone metastasis, which is accompanied by symptom at the time of detection
Time to first on-study fracture (before bone metastasis)	Determined by the time from randomization to the first observation of on-study vertebral or nonvertebral fracture prior to the development of bone metastasis
Time to first on-study SRE (following bone metastasis)	Determined by the time from randomization to the first on-study SRE, defined as any fracture (vertebral or nonvertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression, following the development of bone metastasis

SRE skeletal-related event