3.5 | Pain intensity
There was recorded a significant reduction in pain overall for the study cohort of 12% (p=0.02) by the end of the treatment phase (Figure 5). In addition, all patients diagnosed with bone metastasis reported a significant reduction in pain scores at the end of the treatment phase. A significantly decreased pain score on the NPRS scale was recorded for participants diagnosed with breast or prostate cancer with bone metastatic disease. In the group of patients with breast and prostate cancers with bone metastasis the median score from baseline to 15 days was 7.5 to 3.5, an unadjusted pain improvement from baseline of approximately 40%. The adjusted improvement (re rescue medications) in pain from baseline to day 15 was 33% (p<0.01). From the end of the treatment phase (day 15) following discontinuation of NanaBisTM to the end of the monitoring phase on day 30, there was a change in mean pain scores which corresponded to an overall worsening of pain scores of approximately 13% from baseline values (Figure 5).