A Study to Evaluate the Safety and Efficacy of Zoledronic Acid in the Prevention or Delaying of Bone Metastasis in Patients With Stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC)

Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.

Time frame: Months 6, 12, 18, and 24

Population: Intent-to-Treat Population consisting of all randomized participants.

Percentage of Participants with the Progression-free survival events: disease progression and death. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.

Time frame: Up to 24 months

Population: Intent-to-Treat Population consisting of all randomized participants.

Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.

Time frame: Up to 24 months

Population: Intent-to-Treat Population consisting of all randomized participants.

Time to occurrence of bone metastases was defined as the time from randomization to the date of the first documented bone metastases which could be asymptomatic or symptomatic at the time of detection. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).

Time frame: Months 6, 12, 18, and 24

Population: Intent-to-Treat Population consisting of all randomized participants. Any participant without documented bone metastases at the date of analysis was to be censored at the date of the last bone scan.

Time frame: Months 6, 12, 18, and 24

Population: Intent-to-Treat Population consisting of all randomized participants.

Time to the first skeletal related event defined as the time from randomization to the date of occurrence of the first SRE. Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event

Time frame: Months 6,12, 18, and 24

Population: Intent-to-Treat Population consisting of all randomized participants. Any participant in whom no SRE had been observed during the study was to be censored at the date of the last visit or the date of death whichever was the earlier.

Percentage of participants developing at least 1 bone metastasis, whether or not symptomatic. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).

Time frame: Months 6, 12, 18 and 24

Population: Intent-to-Treat Population consisting of all randomized participants.

Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event.

Time frame: Months 12 and 24

Population: Intent-to-Treat Population consisting of all randomized participants.