PFS was defined as the time from the date of randomization to the date of the event, defined as the first radiologically documented disease progression or death due to any cause. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

FAS per Expert Report: All pts randomized to study treatment. Per ITT principle, pts were analyzed according to treatment & strata. FAS was primary population for analysis of efficacy endpoints at interim. 338 pts were randomized (between 16-Aug-2012 & 07-Jun-2014) in 1:1 ratio to buparlisib + paclitaxel arm N=168 or placebo + paclitaxel arm N=170.

Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last contact.

Full analysis set (FAS) comprises all patients who were randomized to study treatment.

Percentage of patients with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST v1.1. According to this criteria, CR = at least two determinations of CR at least 4 weeks apart before progression; PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

FAS per Expert Report: All pts randomized to study treatment. Per ITT principle, pts were analyzed according to treatment & strata. FAS was primary population for analysis of efficacy endpoints at interim. 338 pts were randomized (between 16-Aug-2012 & 07-Jun-2014) in 1:1 ratio to buparlisib + paclitaxel arm N=168 or placebo + paclitaxel arm N=170.

time from the date of the first documented response (CR or PR, which had to be confirmed subsequently) to the date of the first radiologically documented disease progression or death due to disease

PFS, ORR and CBR were analyzed and reported at the interim analysis. Given the study met the futility analysis per protocol, the duration of response was removed as a secondary endpoint in the final analysis and consequently not analyzed.

time from date of randomization until first documented response (CR or PR, which has to be confirmed subsequently).

PFS, ORR and CBR were analyzed and reported at the interim analysis. Given the study met the futility analysis per protocol, time to response was removed as a secondary endpoint in the final analysis and consequently not analyzed.

CBR was defined as the percentage of patients with an overall response of CR or PR or SD or non-CR/non-PD lasting more than 24 weeks based on local Investigator's assessment according to RECIST v1.1.

FAS per Expert Report: All pts randomized to study treatment. Per ITT principle, pts were analyzed according to treatment & strata. FAS was primary population for analysis of efficacy endpoints at interim. 338 pts were randomized (between 16-Aug-2012 & 07-Jun-2014) in 1:1 ratio to buparlisib + paclitaxel arm N=168 or placebo + paclitaxel arm N=170.

Summary statistics for PK: plasma concentration-time profiles of BKM120 and appropriate individual PK parameters based on population PK model , if deemed appropriate; each cycle = 28 days

PFS, ORR and CBR were analyzed and reported at the interim analysis. Given the study met the futility analysis per protocol, the plasma concentration-time profiles was removed as a secondary endpoint in the final analysis and consequently not analyzed.

Time to definitive deterioration of the ECOG performance status from baseline

PFS, ORR and CBR were analyzed and reported at the interim analysis. Given the study met the futility analysis per protocol, the time to definitive deterioration of ECOG performance status was removed as a secondary endpoint in the final analysis and consequently not analyzed.