Trial Outcomes & Findings for An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease. (NCT NCT01582061)

NCT ID: NCT01582061

Last Updated: 2018-06-19

Results Overview

Only AEs occurring on or after the start of study treatment and no more than 28 days after the discontinuation of study treatment. A patient with multiple occurrences of an AE under one treatment is counted only once in the AE category for that treatment. A patient with multiple severity grades for an AE while on a treatment, is only counted under the maximum grade.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

104 participants

Primary outcome timeframe

Baseline up to approximately 256 weeks

Results posted on

2018-06-19

Participant Flow

After a 21-day screening period, patients who met the inclusion/exclusion criteria received pasireotide subcutaneous twice a day (BID)

Participant milestones

Participant milestones
Measure	Pasireotide 600 μg Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.	Pasireotide 900 μg Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
Overall Study STARTED	49	55
Overall Study COMPLETED	21	19
Overall Study NOT COMPLETED	28	36

Reasons for withdrawal

Reasons for withdrawal
Measure	Pasireotide 600 μg Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.	Pasireotide 900 μg Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
Overall Study Lack of Efficacy	3	23
Overall Study Adverse Event	12	8
Overall Study Withdrawal by Subject	10	4
Overall Study Abnormal laboratory value(s)	1	0
Overall Study Death	0	1
Overall Study condition no longer requires study drug	1	0
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pasireotide 600 μg n=49 Participants Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.	Pasireotide 900 μg n=55 Participants Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day	Total n=104 Participants Total of all reporting groups
Age, Continuous	45.5 years STANDARD_DEVIATION 13.14 • n=5 Participants	39.9 years STANDARD_DEVIATION 12.55 • n=7 Participants	42.5 years STANDARD_DEVIATION 13.07 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	47 Participants n=7 Participants	84 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	15 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants	36 Participants n=7 Participants	75 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to approximately 256 weeks

Population: Three additional arms were created to display subset of subjects with specific criteria.

Outcome measures

Outcome measures
Measure	600 µg Bid - All Grades n=49 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.	600 μg - Grades 3/4 n=49 Participants Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients	900 μg - All Grades n=55 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day	900 μg - Grades 3/4 n=55 Participants Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg	All Patients - All Grades n=104 Participants All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.	All Patients - Grades 3/4 n=104 Participants All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) Any primary system organ class	53.1 percentage of participants	53.1 percentage of participants	29.1 percentage of participants	27.3 percentage of participants	40.4 percentage of participants	39.4 percentage of participants
Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) Metabolism and nutrition disorders	26.5 percentage of participants	26.5 percentage of participants	12.7 percentage of participants	10.9 percentage of participants	19.2 percentage of participants	18.3 percentage of participants
Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) Gastrointestinal disorders	18.4 percentage of participants	18.4 percentage of participants	7.3 percentage of participants	7.3 percentage of participants	12.5 percentage of participants	12.5 percentage of participants
Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) Investigations	8.2 percentage of participants	8.2 percentage of participants	3.6 percentage of participants	3.6 percentage of participants	5.8 percentage of participants	5.8 percentage of participants
Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) Hepatobiliary disorders	2.0 percentage of participants	2.0 percentage of participants	5.5 percentage of participants	5.5 percentage of participants	3.8 percentage of participants	3.8 percentage of participants
Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) Endocrine disorders	6.1 percentage of participants	6.1 percentage of participants	0 percentage of participants	0 percentage of participants	2.9 percentage of participants	2.9 percentage of participants
Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) Gen disorders,admin site conditions	4.1 percentage of participants	4.1 percentage of participants	0 percentage of participants	0 percentage of participants	1.9 percentage of participants	1.9 percentage of participants
Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) Ear and labyrinth disorders	2.0 percentage of participants	2.0 percentage of participants	0 percentage of participants	0 percentage of participants	1.0 percentage of participants	1.0 percentage of participants
Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) Infections and infestations	2.0 percentage of participants	2.0 percentage of participants	0 percentage of participants	0 percentage of participants	1.0 percentage of participants	1.0 percentage of participants
Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) Musculoskeletal and connective tissue disorders	2.0 percentage of participants	2.0 percentage of participants	0 percentage of participants	0 percentage of participants	1.0 percentage of participants	1.0 percentage of participants
Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) Neoplasms benign, malignant and unspecified	2.0 percentage of participants	2.0 percentage of participants	0 percentage of participants	0 percentage of participants	1.0 percentage of participants	1.0 percentage of participants
Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) Nervous system disorders	2.0 percentage of participants	2.0 percentage of participants	0 percentage of participants	0 percentage of participants	1.0 percentage of participants	1.0 percentage of participants
Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) Psychiatric disorders	0 percentage of participants	0 percentage of participants	1.8 percentage of participants	1.8 percentage of participants	1.0 percentage of participants	1.0 percentage of participants
Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) Respiratory, thoracic, mediastinal disorders	0 percentage of participants	0 percentage of participants	1.8 percentage of participants	0 percentage of participants	1.0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, week 12, 24 and 48

Population: LOCF Week 24: last available mean 24h-UFC of at least two samples between and including week 12 and week 24; LOCF Week 48: last available mean 24h-UFC of at least two samples between and including week 12 and week 48. Two-sided 95% confidence intervals for proportions are calculated using the exact method

The 24h-UFC concentration results from three samples during screening were averaged to obtain baseline. After baseline, mean 24h UFC was determined at week 24. At Week 4, 8, 16 and 20, mean 24h UFC was determined from two 24 hour urine collections collected on two consecutive days occurring before the visit. At Week 12, 24 and 48, the mean 24h-UFC from three 24 hour urine collections, collected over the week before the visit, was determined. After Week 24, the mean 24h UFC was determined at 12-week intervals until end of study visit, from two 24 hour collections during two consecutive days prior to each respective visit (except at Week 48). UFC was determined by liquid chromatography tandem mass spectroscopy (LC/MS/MS). The normal ranges were determined by the central laboratory's own reference range. All samples, including screening samples, were analyzed by a central laboratory.

Outcome measures

Outcome measures
Measure	600 µg Bid - All Grades n=49 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.	600 μg - Grades 3/4 n=55 Participants Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients	900 μg - All Grades n=104 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day	900 μg - Grades 3/4 Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg	All Patients - All Grades All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.	All Patients - Grades 3/4 All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
Percentage of Patients With Mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN) Week 12	77.8 percentage of participants Interval 57.74 to 91.38	38.5 percentage of participants Interval 23.36 to 55.38	54.5 percentage of participants Interval 41.81 to 66.86	—	—	—
Percentage of Patients With Mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN) Week 24	68.2 percentage of participants Interval 45.13 to 86.14	29.2 percentage of participants Interval 12.62 to 51.09	47.8 percentage of participants Interval 32.89 to 63.05	—	—	—
Percentage of Patients With Mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN) Week 48	70.0 percentage of participants Interval 34.75 to 93.33	18.2 percentage of participants Interval 2.28 to 51.78	42.9 percentage of participants Interval 21.82 to 65.98	—	—	—
Percentage of Patients With Mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN) Week 24 (LOCF)	54.1 percentage of participants Interval 36.92 to 70.51	28.6 percentage of participants Interval 16.59 to 43.26	39.5 percentage of participants Interval 29.15 to 50.66	—	—	—
Percentage of Patients With Mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN) Week 48 (LOCF)	51.4 percentage of participants Interval 34.4 to 68.08	22.4 percentage of participants Interval 11.78 to 36.62	34.9 percentage of participants Interval 24.92 to 45.92	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 12, 24 and 48

Outcome measures

Outcome measures
Measure	600 µg Bid - All Grades n=49 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.	600 μg - Grades 3/4 n=55 Participants Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients	900 μg - All Grades n=104 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day	900 μg - Grades 3/4 Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg	All Patients - All Grades All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.	All Patients - Grades 3/4 All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
Percentage of Patients Achieving a Reduction of Mean UFC ≥ 50% From Baseline Week 12	74.1 percentage of participants Interval 53.72 to 88.89	48.7 percentage of participants Interval 32.42 to 65.22	59.1 percentage of participants Interval 46.29 to 71.05	—	—	—
Percentage of Patients Achieving a Reduction of Mean UFC ≥ 50% From Baseline Week 24	68.2 percentage of participants Interval 45.13 to 86.14	33.3 percentage of participants Interval 15.63 to 55.32	50.00 percentage of participants Interval 34.9 to 65.1	—	—	—
Percentage of Patients Achieving a Reduction of Mean UFC ≥ 50% From Baseline Week 48	60.0 percentage of participants Interval 26.24 to 87.84	54.5 percentage of participants Interval 23.38 to 83.25	57.1 percentage of participants Interval 34.02 to 78.18	—	—	—
Percentage of Patients Achieving a Reduction of Mean UFC ≥ 50% From Baseline Week 24 (LOCF)	56.8 percentage of participants Interval 39.49 to 72.9	38.8 percentage of participants Interval 25.2 to 53.76	46.5 percentage of participants Interval 35.68 to 57.59	—	—	—
Percentage of Patients Achieving a Reduction of Mean UFC ≥ 50% From Baseline Week 48 (LOCF)	51.4 percentage of participants Interval 34.4 to 68.08	42.9 percentage of participants Interval 28.82 to 57.79	46.5 percentage of participants Interval 35.68 to 57.59	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 12, 24 and 48

Population: Only patients who completed at least 9 questions on questionnaire were included for that visit.

A 12-item Cushing's syndrome HRQoL questionnaire (CushingQoL, cf. Webb et al 2008) was implemented and patients who completed 9 or more items at a visit were considered evaluable for that visit. The standardized scores were calculated as follows: 1) Obtain raw scores, denoted by X, as the sum of all the ratings on all the HRQoL questions for a single patient and the score can range from 12 (worst HRQoL) to 60 points (best HRQoL). Therefore, the lower the score, greater the negative impact on HRQoL and 2) obtain standardized score, Y, for a single patient • Y = 100 (X-12) / (60-12) = 100 (X-12)/48. For example, if a patient answers all 12 items with 'Sometimes' or 'Somewhat', X = 36 and Y = 100 ∙ 24/48 = 50 The WPAI-GH questionnaire was used to assess work productivity and activity impairment. However, there was very limited baseline data and therefore the results and outcomes of the objective, 'change from baseline in WPAI-GH scores' are not included.

Outcome measures

Outcome measures
Measure	600 µg Bid - All Grades n=47 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.	600 μg - Grades 3/4 n=54 Participants Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients	900 μg - All Grades n=101 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day	900 μg - Grades 3/4 Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg	All Patients - All Grades All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.	All Patients - Grades 3/4 All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
Percent Change in Cushing Quality of Life and Work Productivity and Activity Impairment-General Health (WPAI-GH) Scores Week 12	21.3 percent change in score Standard Deviation 47.03	100.8 percent change in score Standard Deviation 252.25	67.1 percent change in score Standard Deviation 197.09	—	—	—
Percent Change in Cushing Quality of Life and Work Productivity and Activity Impairment-General Health (WPAI-GH) Scores Week 24	36.7 percent change in score Standard Deviation 59.25	119.7 percent change in score Standard Deviation 321.61	82.3 percent change in score Standard Deviation 243.19	—	—	—
Percent Change in Cushing Quality of Life and Work Productivity and Activity Impairment-General Health (WPAI-GH) Scores Week 48	24.0 percent change in score Standard Deviation 37.76	42.3 percent change in score Standard Deviation 60.75	34.4 percent change in score Standard Deviation 52.29	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 12, 24 and 48

Population: Number of patients with available data differed at visits

Standing systolic and diastolic BP based on 1 assessment and sitting systolic and diastolic BP was mean of 3 assessments.

Outcome measures

Outcome measures
Measure	600 µg Bid - All Grades n=49 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.	600 μg - Grades 3/4 n=55 Participants Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients	900 μg - All Grades n=104 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day	900 μg - Grades 3/4 Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg	All Patients - All Grades All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.	All Patients - Grades 3/4 All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP) Sitting systolic Week 12	-6.8 percent change of mmhg Standard Deviation 12.04	-1.4 percent change of mmhg Standard Deviation 14.40	-3.8 percent change of mmhg Standard Deviation 13.61	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP) Sitting systolic Week 24	-7.4 percent change of mmhg Standard Deviation 8.97	-5.7 percent change of mmhg Standard Deviation 11.09	-6.5 percent change of mmhg Standard Deviation 10.13	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP) Sitting systolic Week 48	-5.1 percent change of mmhg Standard Deviation 8.57	-4.7 percent change of mmhg Standard Deviation 12.55	-4.9 percent change of mmhg Standard Deviation 10.87	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP) Standing systolic Week 12	-7.9 percent change of mmhg Standard Deviation 12.49	-3.6 percent change of mmhg Standard Deviation 15.38	-5.5 percent change of mmhg Standard Deviation 14.27	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP) Standing systolic Week 24	-10.9 percent change of mmhg Standard Deviation 10.30	-6.7 percent change of mmhg Standard Deviation 14.09	-8.6 percent change of mmhg Standard Deviation 12.62	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP) Standing systolic Week 48	-6.5 percent change of mmhg Standard Deviation 9.45	-4.4 percent change of mmhg Standard Deviation 13.86	-5.3 percent change of mmhg Standard Deviation 12.10	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP) Sitting diastolic Week 12	-4.6 percent change of mmhg Standard Deviation 15.13	-0.2 percent change of mmhg Standard Deviation 14.40	-2.1 percent change of mmhg Standard Deviation 14.79	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP) Sitting diastolic Week 24	-6.2 percent change of mmhg Standard Deviation 7.29	-3.8 percent change of mmhg Standard Deviation 15.83	-4.9 percent change of mmhg Standard Deviation 12.65	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP) Sitting diastolic Week 48	-3.3 percent change of mmhg Standard Deviation 10.38	-4.3 percent change of mmhg Standard Deviation 13.93	-3.8 percent change of mmhg Standard Deviation 12.37	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP) Standing diastolic Week 12	-5.5 percent change of mmhg Standard Deviation 16.02	-1.9 percent change of mmhg Standard Deviation 17.63	-3.5 percent change of mmhg Standard Deviation 16.93	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP) Standing diastolic Week 24	-7.6 percent change of mmhg Standard Deviation 10.30	-5.3 percent change of mmhg Standard Deviation 16.74	-6.3 percent change of mmhg Standard Deviation 14.18	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP) Standing diastolic Week 48	-2.1 percent change of mmhg Standard Deviation 13.78	-4.4 percent change of mmhg Standard Deviation 14.13	-3.4 percent change of mmhg Standard Deviation 13.83	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 12, 24 and 48

Population: Number of patients with available data differed at visits

Change from baseline is shown as: Percent change from baseline (BL) =((Post BL value - BL value)/ BL value)\*100

Outcome measures

Outcome measures
Measure	600 µg Bid - All Grades n=49 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.	600 μg - Grades 3/4 n=55 Participants Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients	900 μg - All Grades n=104 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day	900 μg - Grades 3/4 Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg	All Patients - All Grades All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.	All Patients - Grades 3/4 All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Pulse Sitting pulse Week 12	2.3 percent change in bpm Standard Deviation 18.93	-7.5 percent change in bpm Standard Deviation 11.50	-3.2 percent change in bpm Standard Deviation 15.87	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Pulse Sitting pulse Week 24	-1.8 percent change in bpm Standard Deviation 17.05	-2.6 percent change in bpm Standard Deviation 18.07	-2.2 percent change in bpm Standard Deviation 17.46	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Pulse Sitting pulse Week 48	2.9 percent change in bpm Standard Deviation 16.39	3.7 percent change in bpm Standard Deviation 15.46	3.3 percent change in bpm Standard Deviation 15.65	—	—	—

SECONDARY outcome

Timeframe: Baseline week 12, 24 and 48

Population: Number of patients with available data differed at visits

degrees celius

Outcome measures

Outcome measures
Measure	600 µg Bid - All Grades n=49 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.	600 μg - Grades 3/4 n=55 Participants Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients	900 μg - All Grades n=104 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day	900 μg - Grades 3/4 Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg	All Patients - All Grades All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.	All Patients - Grades 3/4 All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Temperature Week 48	0.03 percent change in celius Standard Deviation 1.47	-0.1 percent change in celius Standard Deviation 1.19	0.1 percent change in celius Standard Deviation 1.31	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Temperature Week 12	0.1 percent change in celius Standard Deviation 1.26	-0.3 percent change in celius Standard Deviation 1.06	-0.1 percent change in celius Standard Deviation 1.17	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Temperature Week 24	-0.1 percent change in celius Standard Deviation 1.15	-0.1 percent change in celius Standard Deviation 1.26	-0.1 percent change in celius Standard Deviation 1.20	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 12, 24 and 48

Population: Number of patients with available data differed at visits

Percent change in patients reducing by at least one class level. Class levels: \<25.0, 25.0 to \<30.0, ≥ 30.0. Percent change from baseline (BL) =((Post BL value - BL value)/ BL value)\*100

Outcome measures

Outcome measures
Measure	600 µg Bid - All Grades n=49 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.	600 μg - Grades 3/4 n=55 Participants Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients	900 μg - All Grades n=104 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day	900 μg - Grades 3/4 Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg	All Patients - All Grades All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.	All Patients - Grades 3/4 All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Body Mass Index (BMI) Week 12	-4.2 percent change in kg/m2 Standard Deviation 3.70	-4.8 percent change in kg/m2 Standard Deviation 5.38	-4.5 percent change in kg/m2 Standard Deviation 4.69	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Body Mass Index (BMI) Week 24	-7.3 percent change in kg/m2 Standard Deviation 5.46	-5.2 percent change in kg/m2 Standard Deviation 6.51	-6.1 percent change in kg/m2 Standard Deviation 6.10	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Body Mass Index (BMI) Week 48	-8.0 percent change in kg/m2 Standard Deviation 6.82	-6.3 percent change in kg/m2 Standard Deviation 7.88	-7.0 percent change in kg/m2 Standard Deviation 7.39	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 12, 24 and 48

Population: Number of patients with available data differed at visits

Clinically relevant threshold (at any time point) was reduction of ≥ 5%

Outcome measures

Outcome measures
Measure	600 µg Bid - All Grades n=49 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.	600 μg - Grades 3/4 n=55 Participants Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients	900 μg - All Grades n=104 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day	900 μg - Grades 3/4 Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg	All Patients - All Grades All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.	All Patients - Grades 3/4 All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Weight Week 12	-4.2 percent change in kg Standard Deviation 3.70	-4.8 percent change in kg Standard Deviation 5.38	-4.5 percent change in kg Standard Deviation 4.69	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Weight Week 24	-7.3 percent change in kg Standard Deviation 5.46	-5.2 percent change in kg Standard Deviation 6.51	-6.1 percent change in kg Standard Deviation 6.10	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Weight Week 48	-8.0 percent change in kg Standard Deviation 6.82	-6.3 percent change in kg Standard Deviation 7.88	-7.0 percent change in kg Standard Deviation 7.39	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 12, 24 and 48

Population: Number of patients with available data differed at visits

Direct observation of ability to stand unaided: 0=able to stand easily with arms extended, 1=able to stand after several efforts without using arms as assistance, 2=able to stand only by using arms as assistance 3=completely unable to stand

Outcome measures

Outcome measures
Measure	600 µg Bid - All Grades n=49 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.	600 μg - Grades 3/4 n=55 Participants Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients	900 μg - All Grades n=104 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day	900 μg - Grades 3/4 Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg	All Patients - All Grades All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.	All Patients - Grades 3/4 All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Muscle Strength Week 12	-34.6 percent change in scores Standard Deviation 62.53	-53.7 percent change in scores Standard Deviation 46.98	-42.4 percent change in scores Standard Deviation 56.28	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Muscle Strength Week 24	-28.6 percent change in scores Standard Deviation 48.80	-47.6 percent change in scores Standard Deviation 50.40	-38.1 percent change in scores Standard Deviation 48.67	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Muscle Strength Week 48	-30.0 percent change in scores Standard Deviation 44.72	-75.0 percent change in scores Standard Deviation 50.0	-50.0 percent change in scores Standard Deviation 50.00	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 12, 24 and 48

Population: Number of patients with available data differed at visits

Clinically relevant threshold (at any time point). Reduction of ≥ 5%, Reduction of ≥ 10%

Outcome measures

Outcome measures
Measure	600 µg Bid - All Grades n=49 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.	600 μg - Grades 3/4 n=55 Participants Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients	900 μg - All Grades n=104 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day	900 μg - Grades 3/4 Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg	All Patients - All Grades All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.	All Patients - Grades 3/4 All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Waist Circumference Week 48	-5.1 percent change of centimeters Standard Deviation 5.74	-4.1 percent change of centimeters Standard Deviation 5.64	-4.6 percent change of centimeters Standard Deviation 5.62	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Waist Circumference Week 12	-2.0 percent change of centimeters Standard Deviation 4.29	-2.9 percent change of centimeters Standard Deviation 6.70	-2.5 percent change of centimeters Standard Deviation 5.72	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Waist Circumference Week 24	-5.8 percent change of centimeters Standard Deviation 6.28	-3.1 percent change of centimeters Standard Deviation 5.48	-4.4 percent change of centimeters Standard Deviation 5.96	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 12, 24 and 48

Population: Number of patients with available data differed at visits

Change from baseline is shown as: Percent change from baseline (BL) =((Post BL value - BL value)/ BL value)\*100. Ferriman-Gallway scoring was used: 0=minimum and 36 was maximum in females only.

Outcome measures

Outcome measures
Measure	600 µg Bid - All Grades n=37 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.	600 μg - Grades 3/4 n=47 Participants Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients	900 μg - All Grades n=84 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day	900 μg - Grades 3/4 Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg	All Patients - All Grades All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.	All Patients - Grades 3/4 All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Hirsutism Week 12	-12.2 percent change in scores Standard Deviation 24.57	-8.2 percent change in scores Standard Deviation 35.30	-10.0 percent change in scores Standard Deviation 30.88	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Hirsutism Week 24	-21.2 percent change in scores Standard Deviation 32.72	-16.2 percent change in scores Standard Deviation 46.99	18.4 percent change in scores Standard Deviation 40.79	—	—	—
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Hirsutism Week 48	-18.2 percent change in scores Standard Deviation 30.12	9.6 percent change in scores Standard Deviation 143.83	-2.2 percent change in scores Standard Deviation 110.20	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 12, 24 and 48

Population: Number of patients with available data differed at visits

Descriptive summary of the effect of pasireotide on GH.

Outcome measures

Outcome measures
Measure	600 µg Bid - All Grades n=48 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.	600 μg - Grades 3/4 n=55 Participants Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients	900 μg - All Grades n=103 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day	900 μg - Grades 3/4 Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg	All Patients - All Grades All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.	All Patients - Grades 3/4 All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
Percent Change From Baseline in Growth Hormone (GH) Values Week 12	-17.3 percent change of µg/L Standard Deviation 109.89	-20.90 percent change of µg/L Standard Deviation 156.60	-19.3 percent change of µg/L Standard Deviation 137.33	—	—	—
Percent Change From Baseline in Growth Hormone (GH) Values Week 24	-22.2 percent change of µg/L Standard Deviation 62.43	-26.2 percent change of µg/L Standard Deviation 105.44	-24.4 percent change of µg/L Standard Deviation 88.70	—	—	—
Percent Change From Baseline in Growth Hormone (GH) Values Week 48	23.1 percent change of µg/L Standard Deviation 127.30	-1.0 percent change of µg/L Standard Deviation 134.97	9.7 percent change of µg/L Standard Deviation 130.32	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 12, 24 and 48

Population: Number of patients with available data differed at visits

Descriptive summary of the effect of pasireotide on IGF-1

Outcome measures

Outcome measures
Measure	600 µg Bid - All Grades n=48 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.	600 μg - Grades 3/4 n=53 Participants Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients	900 μg - All Grades n=101 Participants All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day	900 μg - Grades 3/4 Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg	All Patients - All Grades All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.	All Patients - Grades 3/4 All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
Percent Change From Baseline in Insulin Growth Factor - 1 (IGF - 1) Values Week 48	-41.8 percent change of ng/ml Standard Deviation 35.72	-52.1 percent change of ng/ml Standard Deviation 21.87	-47.6 percent change of ng/ml Standard Deviation 28.71	—	—	—
Percent Change From Baseline in Insulin Growth Factor - 1 (IGF - 1) Values Week 12	-53.4 percent change of ng/ml Standard Deviation 23.66	-57.8 percent change of ng/ml Standard Deviation 23.93	-55.9 percent change of ng/ml Standard Deviation 23.76	—	—	—
Percent Change From Baseline in Insulin Growth Factor - 1 (IGF - 1) Values Week 24	-49.2 percent change of ng/ml Standard Deviation 26.56	-56.2 percent change of ng/ml Standard Deviation 26.55	-53.1 percent change of ng/ml Standard Deviation 26.53	—	—	—

Adverse Events

600 µg Bid

Serious events: 13 serious events

Other events: 49 other events

Deaths: 0 deaths

900 µg Bid

Serious events: 17 serious events

Other events: 54 other events

Deaths: 1 deaths

All Patients

Serious events: 30 serious events

Other events: 103 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER