Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease

Number of mUFC (Urinary Free Cortisol) Responders by Randomized Dose Group

Time frame · 6 months

A responder in the primary efficacy analysis was a patient with a mUFC≤ULN at Month 6 and whose dose was not increased prior to Month 6.

Change From Baseline in mUFC

Time frame · baseline, 3 months, 12 months

Twenty four hour urine samples were collected to obtain mUFC measurements. A negative change from baseline indicates improvement.

Time to First UFC Response

Time frame · 12 months

Time to first UFC response is defined as the number of months from baseline to first attainment of UFC response.

Percent Change From Baseline in Serum Cortisol

Time frame · baseline, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78 months

Blood samlpes were drawn to obtain serum cortisol levels. A negative change from baseline indicates improvement.

Percent Change From Baseline in Mean Adrenocorticotropic Hormone (ACTH)

Time frame · baseline, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78 months

Blood samples were drawn to obtain ACTH levels. A negative change from baseline indicates improvement.

Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Sitting Sytolic Blood Pressure (SBP) and Sitting Diastolic Blood Pressure (DBP)

Time frame · baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60

Sitting blood pressure assessments were performed at every study visit. A negative change from baseline indicates improvement.

Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Mass Index (BMI)

Time frame · baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60

BMI was determined by using height and weight measurements. A negative change from baseline indicates improvement.

Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Waist Circumference

Time frame · baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60

Waist circumference was measured with a measuring tape correctly positioned. A negative change from baseline indicates improvement.

Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Total Cholesterol and Triglycerides

Time frame · baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60

Blood samples were drawn to obtain total cholesterol and triglycerides' levels. A negative change from baseline indicates improvement.

Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Beck Depression Inventory (BDI-II) Score

Time frame · baseline, month 3, month 6, month 12, month 18, month 24

The BDI-II is a 21 item self-report rating inventory measuring characteristic attitudes and symptoms of depression. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The scores range as follows: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. A negative change from baseline indicates imrpovement.

Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Ferriman-Galway Hirsutism Score

Time frame · baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60

The Ferriman Gallwey scoring system is used to score the degree of excess male pattern body hair. The scorecard of every body location under survey begins from 0 (no excessive terminal hair growth) to 4 (extensive terminal hair growth) and the numbers are added up to a maximum count of 36. A score \>= 6 indicates the hirsutism. A negative change from baseline indicates imrpovement.