Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease

Percentage Participants That Attained a mUFC ≤ 1.0 x ULN at Month 7 Regardless of Dose Titration

Time frame · Month 7

Percentage of participants that attained a mean urinary free cortisol (mUFC) \<= 1.0 x upper limit of normal (ULN) at Month 7 regardless of dose up-titration at Month 4. Patients who discontinued before month 4 evaluations classed as non-responders. For patients missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value.

Percentage of Participants That Attained a mUFC ≤ 1.0 x ULN at Month 7 and Had Not Had a Dose Increase at Month 4

Time frame · Month 7

Percentage of participants that attain a mUFC ≤ 1.0×ULN at Month 7 and had not had a dose increase at Month 4. Patients who had a dose increase prior to Month 7 were counted as non-responders in this analysis. Patients who discontinued before month 4 evaluations classed as non-responders. For patients missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value. A responder was defined as a patient who attains mUFC ≤1.0 X ULN and had not had a dose increase at Month 4.

Actual Change in Mean Urinary Free Cortisol (mUFC) From Baseline

Time frame · baseline, Month 7 (M7), Month 12 (M12), Month 24 (M24) , Month 36 (M36)

Actual change in mUFC (nmol/24h) from baseline by randomized groups.

Percentage Change in Mean Urinary Free Cortisol (mUFC) From Baseline

Time frame · M7, M12, M24, M36

Percentage change in mUFC (nmol/24h) from baseline by randomized groups.

Percentage of Patients Who Attain mUFC ≤ 1.0 x ULN

Time frame · M7, M12, M24, M36

Controlled responder: mUFC ≤ 1.0×ULN by randomized groups.

Percentage of Patients Who Attain mUFC ≤1.0 x ULN or Have at Least 50 % Reduction From Baseline in mUFC

Time frame · M7, M12, M24, M36

Controlled responder: mUFC ≤ 1.0×ULN. Partially controlled responder: at least 50% reduction in mUFC from Baseline, and mUFC \>1.0×ULN.

Percentage of Patients Who Are Controlled Responders (mUFC ≤ 1.0 xULN) on at Least 4 of the 7 mUFC Assessments by Month 7 & on at Least 7 of the 12 mUFC Assessments by Month 12.

Time frame · Month 7, Month 12

Percentage of patients with mUFC ≤ 1.0 x ULN at a minimum of 4 months up to and including Month 7, and at a minimum of 7 months up to and including Month 12 by randomized groups.

Percentage of Patients With Uncontrolled Response at Month 7 & Month 12 Within the Subset of Patients Who Had Uncontrolled Response at a) Months 1 and 2; b) Months 1, 2, and 3

Time frame · Month 7, Month12

Percentage of patients with mUFC \> 1.0 xULN at Month 7 and Month 12 within the subset of patients who were uncontrolled at a) Months 1 \& 2, b) Months 1, 2, \& 3 by randomized groups.

Percent of Participants Attaining a mUFC ≤ 1.0 x ULN or at Least a 50% Reduction in mUFC From Baseline at Indicated Time Points

Time frame · Momth 7, Month 12

Time to first achievement of attaining a mUFC ≤ 1.0 x ULN or at least a 50% reduction in mUFC from baseline by randomized groups.

Percent of Participants Attaining a Duration of Controlled or Partially Controlled Response at Indicated Time Points

Time frame · Month 6, 12, 18

Duration of controlled or partially controlled response is defined as the period starting from the date of patient's first normalization (mUFC≤ 1.0 x ULN) or at least 50% reduction from baseline up to the date when the patient's mUFC \>1.0 x ULN and the reduction from baseline falls to less than 50% for the first time.

Percentage Change From Baseline on Plasma Adrenocorticotropic Hormone (ACTH) Over Time

Time frame · Months 7, 12, 24 & 36

Percentage change in ACTH (pmol/L) from Baseline by randomized groups.