Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced Breast Cancer

This outcome describes the number of participants experiencing any type, any grade, any cause adverse events (assessed both subjectively and objectively)

This outcome describes the number of participants experiencing laboratory test abnormalities. The following laboratory test categories were analyzed:

• Enzyme investigations
• Hematology investigations
• Hepatobiliary investigations
• Lipid investigations
• Protein and chemistry analyses
• Renal and urinary tract investigations
• Water, electrolytes and mineral investigation. Laboratory test abnormalities were graded according to the NCI Common Toxicity Criteria version 2 (JCOG Version), resulting in a score from Grade 0 (Normal) to Grade 5 (Death due to toxicity).

Only laboratory test abnormalities with a Grade 3 or higher are reported

ORR is defined as the number (percentage) of participants achieving either a Complete Response (CR) or Partial Response (PR) to therapy. CR is defined as disappearance of all target lesions, while PR is defined as at least a 30% decrease in the sum of longest diameter (LD) of all target lesions (taking as reference the baseline sum LD).

Target Lesions were evaluated according to "Evaluation Criteria on the Therapeutic Effects in Patients with Advanced or Recurrent Breast Cancer."

DOR is defined as the median time from the first date of Partial Response (assessed as per the "Evaluation Criteria on the Therapeutic Effects in Patients with Advanced or Recurrent Breast Cancer") to the first date of Progressive Disease. Participants were evaluated for DOR in 2 separate studies (NCT01023204 and NCT00971945). Results are representative of the cumulative DOR assessed in both studies.