PFS per RECIST 1.0. (Response Evaluation Criteria in Solid Tumors). PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.

The FAS consisted of all randomized patients. Following the intention to treat principle patients were analyzed according to the treatment (and stratum) they were assigned to at randomization.

One patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems.

Consisted of monitoring and recording the rate, type, severity, and causal relationship of adverse events (AEs) and serious AEs (SAEs) to treatment. The safety analysis was based mainly on the frequency of AEs or SAEs and on the number of laboratory values that fell outside of pre-determined range.

Safety analysis population included all patients who received any study medication (i.e. at least 1 dose of the study drug in case of monotherapy or at least 1 dose of any 1 compound of the study treatment in case of a combination therapy) with a post-Baseline safety assessment.

See Adverse Events (AE) section for all AEs collected.

Objective response was determined by the local radiologist according to the RECIST Version 1.0. ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR). This is also referred to as Overall response rate.

CR: Disappearance of all nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameter of all target lesions recorded at or after baseline.

The FAS consisted of all randomized patients.1 patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems. The study was terminated because the study did not meet its primary objective so minimal efficacy data was obtained.

80 PFS are expected after approximately 24 months. Kaplan Meier was initially planned to be used to depict duration of response by treatment group and by stratum. Later based on the mode of action of everolimus and pasireotide and based on study experience, only a low number of objective responses per RECIST were expected. Therefore, protocol was amended to only list duration of response, and confirmed responses were flagged in the listing. Hence, statistical analyses were not planned and such data are not available for the following table.

The FAS consisted of all randomized patients. Only a low number of objective responses per RECIST was expected. Therefore, protocol was amended to only list duration of response, and confirmed responses were flagged in the listing. Hence, statistical analyses were not planned and such data are not available for the following table.

Overall survival was defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival was to be censored at the date of last contact.

The FAS consisted of all randomized patients.1 patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems. The study was terminated because the study did not meet its primary objective so minimal efficacy data was obtained.

105 PFS events expected after approximately 36 months

Since the study was terminated because the study did not meet its primary objective which was based on PFS as per local radiology assessment, minimal efficacy data was obtained. Only 80 PFS events occurred before study was terminated so 105 PFS events was not reached to analyze this data.

Disease control rate is the percentage of patients with a best overall response of CR or PR or stable disease (SD) determined by the local radiologist according to the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) Version 1.0. CR: Disappearance of all nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameter of all target lesions recorded at or after baseline. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD). PD: Any progression ≤ 18 weeks after randomization (and not qualifying for CR, PR or stable disease SD.

The FAS consisted of all randomized patients.1 patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems. The study was terminated because the study did not meet its primary objective so minimal efficacy data was obtained.

PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.

PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.

PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.

PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.

PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.