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Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

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ClinicalTrials.gov Identifier: NCT00600886
Recruitment Status : Completed
First Posted : January 25, 2008
Results First Posted : January 30, 2015
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Acromegaly
Interventions Drug: Pasireotide
Drug: Octreotide
Enrollment 358
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pasireotide LAR Octreotide LAR
Hide Arm/Group Description Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension. Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension.
Period Title: Core Phase - Full Analysis Set (FAS)
Started 176 182
Did Not Enter Extension 29 29
Entered Extension, Crossed Over 38 81
Entered Ext Continued Same Treatment 74 46
Completed 141 [1] 156 [1]
Not Completed 35 26
Reason Not Completed
Adverse Event             14             6
Protocol Violation             7             8
Lack of Efficacy             5             8
Withdrawal by Subject             5             3
Administrative Problems             2             0
Abnormal laboratory value(s)             1             0
Lost to Follow-up             1             0
Death             0             1
[1]
Completed = anyone who did not discontinue prior to month 12.
Period Title: Extension - Same Treatment (FAS)
Started 74 [1] 46 [2]
Completed Study at Month 26 0 [3] 31 [4]
Completed Study After Month 26 28 [5] 4 [6]
Discontinued After Month 26 23 1 [7]
Discontinued Between M12 and M26 23 10
Completed 28 [8] 35 [9]
Not Completed 46 11
Reason Not Completed
Withdrawal by Subject             16             2
Lack of Efficacy             3             3
Administrative Problems             9             3
Lost to Follow-up             3             1
Adverse Event             4             1
Abnormal Lab Value (s)             4             0
Death             1             1
Condition no longer requires study drug             6             0
[1]
Started = anyone who entered the extension and continued the same treatment of Pasireotide LAR
[2]
Started = anyone who entered the extension and continued the same treatment of Octreotide LAR
[3]
Pas. LAR pts in Ext. were not considered completers at M26 as treatment could continue after M26.
[4]
Per protocol, pts who received Octreotide LAR in ext. phase were not followed in the study after M26
[5]
Completed = Pts who transferred to a roll-over protocol or commercial supply of Pasireotide LAR
[6]
Received treatment and completed after M26: Recorded as protocol deviation
[7]
Received treatment and discontinued after M26: Recorded as protocol deviation
[8]
Completed= completed after M26, switched to commercial pasireotide LAR or entered roll-over protocol
[9]
Completed = completed the study
Period Title: Extension - After Crossover (CAS)
Started 81 [1] 38 [2]
Completed Study at Month 26 0 [3] 25 [4]
Completed After Month 26 19 [5] 0 [4]
Discontinued Between M12 and M26 31 13
Discontinued After M26 31 0 [4]
Completed 19 [6] 25 [7]
Not Completed 62 13
Reason Not Completed
Adverse Event             19             1
Withdrawal by Subject             19             4
Lack of Efficacy             13             4
Administrative Problems             4             4
Subject no longer requires study drug             3             0
Abnormal Lab Value (s)             3             0
Death             1             0
[1]
Started = anyone who entered the extension and crossed over to Pasireotide LAR
[2]
Started = anyone who entered the extension and crossed over to Octreotide LAR
[3]
Pas. LAR pts in Ext. were not considered completers at M26 as treatment could continue after M26.
[4]
Per protocol, Pts who received Octreotide LAR in Ext. phase were not followed in study after M26
[5]
Completed = Pts who transferred to a roll-over protocol or commercial supply of Pasireotide LAR
[6]
Completed after month 26: transferred to a roll-over protocol or commercial supply of Pas.LAR
[7]
Completed the study
Arm/Group Title Pasireotide LAR Octreotide LAR Total
Hide Arm/Group Description Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension. Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension. Total of all reporting groups
Overall Number of Baseline Participants 176 182 358
Hide Baseline Analysis Population Description
Full Analysis Set: All patients who were randomized into the study. Patients were analyzed according to the treatment they were assigned to at randomization.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 176 participants 182 participants 358 participants
45.1  (12.37) 45.6  (12.97) 45.4  (12.67)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 176 participants 182 participants 358 participants
<65 Years 168 167 335
>=65 years 8 15 23
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 182 participants 358 participants
Female
91
  51.7%
95
  52.2%
186
  52.0%
Male
85
  48.3%
87
  47.8%
172
  48.0%
1.Primary Outcome
Title Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1
Hide Description

Percentage of participants with a reduction of mean GH levels to <2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1.

Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.

Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing mean GH and/or IGF-1 levels at M12 were imputed using data obtained at or after M6 by the last observation carried forward method; otherwise, Pts were considered as non-responders.
Arm/Group Title Pasireotide LAR (Core) Octreotide LAR (Core)
Hide Arm/Group Description:
Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
Overall Number of Participants Analyzed 176 182
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Overall Number Analyzed 176 participants 182 participants
31.3
(24.5 to 38.7)
19.2
(13.8 to 25.7)
Post Surgery Number Analyzed 71 participants 78 participants
39.4
(28.0 to 51.7)
21.8
(13.2 to 32.6)
De novo Number Analyzed 105 participants 104 participants
25.7
(17.7 to 35.2)
17.3
(10.6 to 26.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pasireotide LAR (Core), Octreotide LAR (Core)
Comments Overall - All patients
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel adjusting for randomization stratification factor
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.942
Confidence Interval (2-Sided) 95%
1.190 to 3.168
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pasireotide LAR (Core), Octreotide LAR (Core)
Comments Post surgery - patients with prior surgery but no previous medical treatment for acromegaly
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.337
Confidence Interval (2-Sided) 95%
1.140 to 4.790
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pasireotide LAR (Core), Octreotide LAR (Core)
Comments De novo - patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.654
Confidence Interval (2-Sided) 95%
0.846 to 3.234
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L
Hide Description

Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile).

Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.

Time Frame 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing mean GH levels at Month 12 were imputed using data obtained at or after Month 6 by the LOCF (last observation carried forward) method; otherwise, Pts were considered as non-responders.
Arm/Group Title Pasireotide LAR (Core) Octreotide LAR (Core)
Hide Arm/Group Description:
Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
Overall Number of Participants Analyzed 176 182
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Overall Number Analyzed 176 participants 182 participants
48.3
(40.7 to 55.9)
51.6
(44.1 to 59.1)
Post surgery Number Analyzed 71 participants 78 participants
52.1
(39.9 to 64.1)
51.3
(39.7 to 62.8)
De novo Number Analyzed 105 participants 104 participants
45.7
(36.0 to 55.7)
51.9
(41.9 to 61.8)
3.Secondary Outcome
Title Change From Baseline in Tumor Volume at 12 Months
Hide Description Absolute and percentage change from baseline in tumor volume (assessed by pituitary MRI) Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.
Time Frame Baseline, 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All patients who were randomized into the study. Patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Pasireotide LAR (Core) Octreotide LAR (Core)
Hide Arm/Group Description:
Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
Overall Number of Participants Analyzed 176 182
Mean (Standard Deviation)
Unit of Measure: mm^3
Overall at baseline Number Analyzed 166 participants 169 participants
2420.7  (4159.21) 2259.2  (3390.20)
Overall % change at month 12 Number Analyzed 120 participants 124 participants
-39.7  (21.83) -38.0  (24.47)
Post surgery at baseline Number Analyzed 70 participants 74 participants
2185.2  (2861.09) 2196.5  (3922.08)
Post surgery % change at month 12 Number Analyzed 44 participants 52 participants
-39.5  (20.60) -39.0  (23.81)
De novo at baseline Number Analyzed 96 participants 95 participants
2592.4  (4901.99) 2308.1  (2930.84)
De novo % change at month 12 Number Analyzed 76 participants 72 participants
-39.9  (22.65) -37.2  (25.07)
Overall absolute change at month 12 Number Analyzed 121 participants 128 participants
-987.1  (2448.14) -801.2  (1676.62)
Post surgery abs. change at month 12 Number Analyzed 44 participants 55 participants
-873.7  (1282.06) -713.8  (1708.20)
De novo absolute change at month 12 Number Analyzed 77 participants 73 participants
-1051.9  (2919.18) -867.1  (1661.24)
4.Secondary Outcome
Title Percentage of Participants With Normalization of IGF-1
Hide Description Percentage of participants with normalization of sex- and age-adjusted IGF-1. Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.
Time Frame 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing IGF-1 levels at Month 12 were imputed using data obtained at or after Month 6 by the LOCF (last observation carried forward) method; otherwise, Pts were considered as nonresponders.
Arm/Group Title Pasireotide LAR (Core) Octreotide LAR (Core)
Hide Arm/Group Description:
Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
Overall Number of Participants Analyzed 176 182
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Overall Number Analyzed 176 participants 182 participants
38.6
(31.4 to 46.3)
23.6
(17.7 to 30.5)
Post surgery Number Analyzed 71 participants 78 participants
50.7
(38.6 to 62.8)
26.9
(17.5 to 38.2)
De novo Number Analyzed 105 participants 104 participants
30.5
(21.9 to 40.2)
21.2
(13.8 to 30.3)
5.Secondary Outcome
Title Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1
Hide Description

Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1.

Denominator for time points up to Month 12 is the Full Analysis Set (FAS). Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover. Analysis was based on data up to crossover (i.e., included data from both blinded core & ext. phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included.)

Time Frame Months 3, 6, 9, 12, 16, 19, 22, 25
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All patients who were randomized into the study.
Arm/Group Title Pasireotide LAR (Core & Extension) Octreotide LAR (Core & Extension)
Hide Arm/Group Description:
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Overall Number of Participants Analyzed 176 182
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Month 3 Number Analyzed 176 participants 182 participants
30.1
(23.4 to 37.5)
21.4
(15.7 to 28.1)
Month 6 Number Analyzed 176 participants 182 participants
30.1
(23.4 to 37.5)
19.8
(14.3 to 26.3)
Month 9 Number Analyzed 176 participants 182 participants
27.8
(21.4 to 35.1)
23.1
(17.2 to 29.9)
Month 12 Number Analyzed 176 participants 182 participants
29.0
(22.4 to 36.3)
17.6
(12.3 to 23.9)
Month 16 Number Analyzed 147 participants 153 participants
25.2
(18.4 to 33.0)
12.4
(7.6 to 18.7)
Month 19 Number Analyzed 147 participants 153 participants
23.1
(16.6 to 30.8)
13.7
(8.7 to 20.2)
Month 22 Number Analyzed 147 participants 153 participants
25.2
(18.4 to 33.0)
16.3
(10.9 to 23.2)
Month 25 Number Analyzed 147 participants 153 participants
24.5
(17.8 to 32.3)
13.7
(8.7 to 20.2)
6.Secondary Outcome
Title Summary of Mean GH Values
Hide Description Mean GH levels (based on a 5-point profile over 2 hours). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Time Frame Baseline, Months 3, 6, 9, 12, 16, 19, 22, 25
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All patients who were randomized into the study.
Arm/Group Title Pasireotide LAR (Core & Extension) Octreotide LAR (Core & Extension)
Hide Arm/Group Description:
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Overall Number of Participants Analyzed 176 182
Mean (Standard Deviation)
Unit of Measure: μg/L
Baseline Number Analyzed 167 participants 178 participants
21.9  (32.14) 18.8  (25.95)
Month 3 Number Analyzed 164 participants 173 participants
6.3  (12.54) 5.8  (12.87)
Month 6 Number Analyzed 151 participants 165 participants
5.6  (11.47) 5.2  (10.99)
Month 9 Number Analyzed 136 participants 157 participants
4.9  (9.62) 4.3  (9.70)
Month 12 Number Analyzed 136 participants 151 participants
4.6  (9.51) 4.5  (11.34)
Month 16 Number Analyzed 64 participants 38 participants
2.3  (5.64) 1.4  (1.49)
Month 19 Number Analyzed 62 participants 38 participants
2.1  (5.68) 1.5  (1.68)
Month 22 Number Analyzed 60 participants 39 participants
2.1  (6.15) 1.4  (1.43)
Month 25 Number Analyzed 62 participants 40 participants
2.0  (5.02) 1.2  (1.11)
7.Secondary Outcome
Title Time to First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 (No. of Responders: Pasireotite LAR = 81, Octreotide LAR = 63) )
Hide Description Time to first response for patients achieving a reduction of mean GH level to < 2.5 μg/L and normalization of IGF-1. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Time Frame Up to 26 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All patients who were randomized into the study.
Arm/Group Title Pasireotide LAR (Core & Extension) Octreotide LAR (Core & Extension)
Hide Arm/Group Description:
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Overall Number of Participants Analyzed 176 182
Median (95% Confidence Interval)
Unit of Measure: Weeks
12.6
(12.3 to 13.0)
12.4
(12.3 to 13.7)
8.Secondary Outcome
Title Severity Scores of Acromegaly Symptoms
Hide Description Severity scores of acromegaly symptoms (Headache, Fatigue, Perspiration, Paresthesias, Osteoarthralgia). Symptoms were scored from 0 (no symptom) to 4 (very severe). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Time Frame Baseline, Months 12, 25
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All patients who were randomized into the study.
Arm/Group Title Pasireotide LAR (Core & Extension) Octreotide LAR (Core & Extension)
Hide Arm/Group Description:
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Overall Number of Participants Analyzed 176 182
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Headache - Baseline Number Analyzed 175 participants 181 participants
0.9  (1.05) 1.0  (1.14)
Fatigue - Baseline Number Analyzed 175 participants 181 participants
1.2  (1.13) 1.4  (1.23)
Perspiration - Baseline Number Analyzed 175 participants 181 participants
1.1  (1.21) 1.3  (1.31)
Paresthesia - Baseline Number Analyzed 175 participants 180 participants
0.7  (1.00) 0.8  (1.15)
Osteoarthraliga - Baseline Number Analyzed 174 participants 178 participants
1.0  (1.05) 1.3  (1.26)
Headache - M12 Number Analyzed 138 participants 149 participants
0.5  (0.77) 0.6  (0.79)
Fatigue - M12 Number Analyzed 138 participants 149 participants
0.8  (0.95) 0.7  (0.99)
Perspiration - M12 Number Analyzed 138 participants 149 participants
0.4  (0.81) 0.5  (0.91)
Paresthesia - M12 Number Analyzed 138 participants 149 participants
0.3  (0.63) 0.4  (0.72)
Osteoarthraliga - M12 Number Analyzed 137 participants 149 participants
0.5  (0.80) 0.7  (1.00)
Headache - M25 Number Analyzed 64 participants 40 participants
0.4  (0.61) 0.6  (0.77)
Fatigue - M25 Number Analyzed 64 participants 40 participants
0.5  (0.71) 0.7  (0.89)
Perspiration - M25 Number Analyzed 64 participants 40 participants
0.4  (0.72) 0.4  (0.67)
Paresthesia - M25 Number Analyzed 64 participants 40 participants
0.2  (0.49) 0.4  (0.67)
Osteoarthraliga - M25 Number Analyzed 64 participants 40 participants
0.4  (0.79) 0.8  (1.07)
9.Secondary Outcome
Title Ring Size
Hide Description Ring size (based on jeweler’s finger gauge). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Time Frame Baseline, Months 12, 25
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All patients who were randomized into the study.
Arm/Group Title Pasireotide LAR (Core & Extension) Octreotide LAR (Core & Extension)
Hide Arm/Group Description:
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Overall Number of Participants Analyzed 176 182
Mean (Standard Deviation)
Unit of Measure: ring zize
Baseline left hand (LH) 4th digit Number Analyzed 112 participants 115 participants
11.6  (2.00) 11.8  (1.97)
Baseline left hand 5th digit Number Analyzed 21 participants 18 participants
11.7  (2.82) 12.4  (2.88)
Baseline right hand (RH) 4th digit Number Analyzed 23 participants 29 participants
12.5  (2.01) 11.4  (2.54)
Baseline right hand 5th digit Number Analyzed 5 participants 8 participants
11.2  (3.35) 11.3  (2.95)
M12 LH 4th digit Number Analyzed 97 participants 102 participants
10.6  (2.05) 11.1  (1.95)
M12 LH 5th digit Number Analyzed 12 participants 10 participants
11.8  (1.81) 12.4  (1.78)
M12 RH 4th digit Number Analyzed 21 participants 25 participants
12.2  (2.12) 11.3  (2.18)
M12 RH 5th digit Number Analyzed 5 participants 6 participants
10.7  (3.96) 10.5  (2.14)
M25 LH 4th digit Number Analyzed 49 participants 33 participants
10.1  (2.12) 11.1  (1.95)
M25 LH 5th digit Number Analyzed 5 participants 2 participants
10.0  (2.45) 14.3  (0.35)
M25 RH 4th digit Number Analyzed 8 participants 4 participants
11.8  (1.98) 10.9  (1.65)
M25 RH 5th digit Number Analyzed 2 participants 1 participants
7.8  (4.60) 7.5 [1]   (NA)
[1]
N/A = Not applicable for Std. Dev.
10.Secondary Outcome
Title Health-related Quality-of-life as Measured by the AcroQoL Questionnaire
Hide Description Acromegalyy quality of life (AcroQoL) total scores. The AcroQoL questionnaire is unidimensional and contains 22 items divided in two scales: one that evaluates physical aspects (eight items) and another one that evaluates psychological aspects (14 items). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Time Frame Baseline, Months 12, 25
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All patients who were randomized into the study.
Arm/Group Title Pasireotide LAR (Core & Extension) Octreotide LAR (Core & Extension)
Hide Arm/Group Description:
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Overall Number of Participants Analyzed 176 182
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline Number Analyzed 173 participants 178 participants
58.4  (19.97) 55.6  (19.79)
M12 Number Analyzed 136 participants 148 participants
65.7  (21.64) 61.6  (21.01)
M25 Number Analyzed 58 participants 38 participants
69.3  (18.76) 62.9  (18.86)
11.Secondary Outcome
Title Summary of Prolactin Levels
Hide Description Prolactin Levels. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Time Frame Baseline, Months 12, 25
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All patients who were randomized into the study.
Arm/Group Title Pasireotide LAR (Core & Extension) Octreotide LAR (Core & Extension)
Hide Arm/Group Description:
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Overall Number of Participants Analyzed 176 182
Mean (Standard Deviation)
Unit of Measure: μg/L
Baseline Number Analyzed 176 participants 182 participants
20.6  (53.00) 15.8  (22.05)
M12 Number Analyzed 135 participants 146 participants
8.9  (19.24) 11.7  (19.09)
M25 Number Analyzed 63 participants 40 participants
5.4  (4.37) 6.7  (4.63)
12.Secondary Outcome
Title Duration of Response for Patients Achieving a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 at Month 12 (No. of Responders: Pasireotide LAR = 51, Octreotide LAR = 32)
Hide Description

The duration of response is defined as the time from the date that patient first met and maintained the response criteria based on primary efficacy variable to the date that patient lost response status.

Median and corresponding 95% CI are derived based on Kaplan-Meier method. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).

Time Frame Up to 26 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All patients who were randomized into the study.
Arm/Group Title Pasireotide LAR (Core & Extension) Octreotide LAR (Core & Extension)
Hide Arm/Group Description:
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Overall Number of Participants Analyzed 176 182
Median (95% Confidence Interval)
Unit of Measure: Weeks
64.4
(52.1 to 100.4)
64.6
(40.0 to 92.0)
13.Secondary Outcome
Title Pasireotide Trough Concentrations by Incident Dose
Hide Description

Pasireotide LAR trough concentrations by incident dose (last dose administered prior to PK sample collection). PK observations with missing concentrations, missing dose, missing elapsed time or an elapsed time from previous injection outside of 28±2 days window were excluded.

5 patients with evaluable PK data in the pasireotide arm received erroneously 20 mg pasireotide LAR at baseline.

Time Frame Months 1 - 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK analysis set: All patients with at least one LAR injection and one post-dose trough concentration data in core phase (up to month 12). No participants took the 60 mg dose in Months 1, 2 and 3, hence no data.
Arm/Group Title Pasireotide LAR 20 mg Pasireotide LAR 40 mg Pasireotide LAR 60mg
Hide Arm/Group Description:
Patients in this arm received Pasireotide LAR 20 mg injection prior to PK sample collection.
Patients in this arm received Pasireotide LAR 40 mg injection prior to PK sample collection.
Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Overall Number of Participants Analyzed 172 172 172
Mean (Standard Deviation)
Unit of Measure: ng/mL
M1 Number Analyzed 5 participants 146 participants 0 participants
4.65  (0.645) 6.65  (3.641)
M2 Number Analyzed 6 participants 135 participants 0 participants
2.88  (1.371) 7.81  (3.505)
M3 Number Analyzed 2 participants 135 participants 0 participants
3.39  (2.659) 8.70  (5.402)
M4 Number Analyzed 3 participants 88 participants 49 participants
3.93  (1.858) 9.51  (5.487) 13.48  (7.750)
M5 Number Analyzed 4 participants 77 participants 56 participants
5.22  (4.077) 10.92  (6.017) 13.42  (6.902)
M6 Number Analyzed 3 participants 71 participants 57 participants
2.87  (1.101) 10.59  (6.216) 13.08  (6.967)
M7 Number Analyzed 3 participants 69 participants 60 participants
2.29  (0.857) 11.85  (7.781) 14.76  (6.868)
M8 Number Analyzed 3 participants 63 participants 70 participants
3.65  (1.865) 12.33  (7.619) 15.88  (9.073)
M9 Number Analyzed 4 participants 59 participants 65 participants
4.80  (1.957) 12.75  (8.604) 16.03  (10.852)
M10 Number Analyzed 5 participants 61 participants 59 participants
5.66  (3.606) 12.42  (7.252) 16.01  (11.497)
M11 Number Analyzed 5 participants 53 participants 65 participants
5.10  (2.375) 12.62  (6.920) 16.31  (10.596)
M12 Number Analyzed 4 participants 45 participants 58 participants
4.54  (1.634) 11.11  (6.489) 16.16  (9.323)
14.Secondary Outcome
Title Octreotide Trough Concentrations by Incident Dose
Hide Description Octreotide LAR trough concentrations by incident dose (last dose administered prior to PK sample collection). PK observations with missing concentrations, missing dose, missing elapsed time or an elapsed time from previous injection outside of 28±2 days window were excluded.
Time Frame Months 1 - 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK analysis set: All patients with at least one LAR injection and one post-dose trough concentration data in core phase (up to month 12). No participants took the 30 mg dose in Months 1, 2 and 3, hence no data.
Arm/Group Title Octreotide LAR 10mg Octreotide LAR 20 mg Octreotide LAR 30 mg
Hide Arm/Group Description:
Patients in this arm received Octreotide LAR 10 mg injection prior to PK sample collection.
Patients in this arm received Octreotide LAR 20 mg injection prior to PK sample collection.
Patients in this arm received Octreotide LAR 30 mg injection prior to PK sample collection.
Overall Number of Participants Analyzed 178 178 178
Mean (Standard Deviation)
Unit of Measure: ng/mL
M1 Number Analyzed 0 participants 153 participants 0 participants
0.86  (0.493)
M2 Number Analyzed 2 participants 139 participants 0 participants
0.61  (0.280) 1.21  (0.663)
M3 Number Analyzed 2 participants 134 participants 0 participants
0.62  (0.107) 1.29  (0.654)
M4 Number Analyzed 1 participants 79 participants 64 participants
0.19 [1]   (NA) 1.45  (0.653) 1.55  (0.658)
M5 Number Analyzed 0 participants 63 participants 82 participants
1.65  (0.876) 2.14  (1.156)
M6 Number Analyzed 2 participants 62 participants 88 participants
1.33  (0.754) 1.58  (0.811) 2.12  (0.990)
M7 Number Analyzed 1 participants 61 participants 82 participants
0.70 [1]   (NA) 1.46  (0.704) 2.14  (1.009)
M8 Number Analyzed 0 participants 50 participants 88 participants
1.55  (0.727) 2.16  (1.127)
M9 Number Analyzed 0 participants 47 participants 93 participants
1.74  (1.013) 2.20  (0.992)
M10 Number Analyzed 0 participants 49 participants 82 participants
1.66  (0.995) 2.50  (1.194)
M11 Number Analyzed 0 participants 43 participants 87 participants
1.74  (0.890) 2.39  (1.103)
M12 Number Analyzed 1 participants 37 participants 76 participants
0.30 [1]   (NA) 1.58  (0.695) 2.55  (1.252)
[1]
N/A = Insufficient number of participants to calculate standard deviation.
15.Secondary Outcome
Title Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 After Crossover
Hide Description Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).
Time Frame Months 3, 6, 9, 12 after crossover
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Crossover Analysis Set (CAS): All patients whose first dose in the extension is different from the first dose in the core.

Patients were analyzed according to the crossover treatment received.

Arm/Group Title Crossed Over to Pasireotide LAR (Extension) Crossed Over to Octreotide LAR (Extension)
Hide Arm/Group Description:
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
Overall Number of Participants Analyzed 81 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
M3 after crossover
17.3
(9.8 to 27.3)
2.6
(0.1 to 13.8)
M6 after crossover
21.0
(12.7 to 31.5)
2.6
(0.1 to 13.8)
M9 after crossover
22.2
(13.7 to 32.8)
5.3
(0.6 to 17.7)
M12 after crossover
17.3
(9.8 to 27.3)
0.0 [1] 
(NA to NA)
[1]
N/A = For zero proportions, confidence intervals were not calculated
16.Secondary Outcome
Title Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L
Hide Description

Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile).

Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). Denominator for time points up to Month 12 is the Full Analysis Set. Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover.

Time Frame Months 3, 6, 9, 12, 16, 19, 22, 25
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All patients who were randomized into the study.
Arm/Group Title Pasireotide LAR (Core & Extension) Octreotide LAR (Core & Extension)
Hide Arm/Group Description:
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Overall Number of Participants Analyzed 176 182
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
M3 Number Analyzed 176 participants 182 participants
49.4
(41.8 to 57.1)
43.4
(36.1 to 50.9)
M6 Number Analyzed 176 participants 182 participants
45.5
(37.9 to 53.1)
47.8
(40.4 to 55.3)
M9 Number Analyzed 176 participants 182 participants
42.6
(35.2 to 50.3)
46.2
(38.8 to 53.7)
M12 Number Analyzed 176 participants 182 participants
43.2
(35.8 to 50.8)
47.3
(39.8 to 54.8)
M16 Number Analyzed 147 participants 153 participants
33.3
(25.8 to 41.6)
22.2
(15.9 to 29.6)
M19 Number Analyzed 147 participants 153 participants
36.7
(28.9 to 45.1)
21.6
(15.3 to 28.9)
M22 Number Analyzed 147 participants 153 participants
35.4
(27.7 to 43.7)
22.2
(15.9 to 29.6)
M25 Number Analyzed 147 participants 153 participants
35.4
(27.7 to 43.7)
24.2
(17.6 to 31.8)
17.Secondary Outcome
Title Percentage of Participants With Normalization of IGF-1
Hide Description Percentage of participants with normalization of sex- and age-adjusted IGF-1. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). Denominator for time points up to Month 12 is the FAS. Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover.
Time Frame Months 3, 6, 9, 12, 16, 19, 22, 25
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All patients who were randomized into the study.
Arm/Group Title Pasireotide LAR (Core & Extension) Octreotide LAR (Core & Extension)
Hide Arm/Group Description:
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Overall Number of Participants Analyzed 176 182
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
M3 Number Analyzed 176 participants 182 participants
35.2
(28.2 to 42.8)
25.3
(19.1 to 32.2)
M6 Number Analyzed 176 participants 182 participants
35.8
(28.7 to 43.4)
24.2
(18.1 to 31.1)
M9 Number Analyzed 176 participants 182 participants
34.1
(27.1 to 41.6)
28.0
(21.6 to 35.1)
M12 Number Analyzed 176 participants 182 participants
35.8
(28.7 to 43.4)
22.0
(16.2 to 28.7)
M16 Number Analyzed 147 participants 153 participants
29.9
(22.7 to 38.0)
13.7
(8.7 to 20.2)
M19 Number Analyzed 147 participants 153 participants
25.2
(18.4 to 33.0)
15.7
(10.3 to 22.4)
M22 Number Analyzed 147 participants 153 participants
25.9
(19.0 to 33.7)
17.0
(11.4 to 23.9)
M25 Number Analyzed 147 participants 153 participants
25.9
(19.0 to 33.7)
14.4
(9.2 to 21.0)
18.Secondary Outcome
Title Change From Baseline in Tumor Volume
Hide Description Percentage change from baseline in tumor volume (assessed by pituitary MRI). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Time Frame Baseline, months 6, 12, 19, 25
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All patients who were randomized into the study.
Arm/Group Title Pasireotide LAR (Core & Extension) Octreotide LAR (Core & Extension)
Hide Arm/Group Description:
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Overall Number of Participants Analyzed 176 182
Mean (Standard Deviation)
Unit of Measure: mm^3
Baseline Number Analyzed 166 participants 169 participants
2420.7  (4159.21) 2259.2  (3390.20)
M6 Number Analyzed 148 participants 160 participants
1614.1  (2536.46) 1565.4  (2245.99)
M12 Number Analyzed 125 participants 138 participants
1482.4  (2387.88) 1390.4  (2179.93)
M19 Number Analyzed 59 participants 37 participants
956.6  (1806.72) 1009.9  (1578.75)
M25 Number Analyzed 59 participants 36 participants
840.4  (1706.07) 814.1  (1306.58)
% change at M6 Number Analyzed 142 participants 145 participants
-29.9  (21.73) -28.8  (20.22)
% change at M12 Number Analyzed 120 participants 124 participants
-39.7  (21.83) -38.0  (24.47)
% change at M19 Number Analyzed 56 participants 35 participants
-48.9  (22.81) -47.2  (24.08)
% change at M25 Number Analyzed 54 participants 34 participants
-51.8  (20.81) -55.0  (21.27)
19.Secondary Outcome
Title Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L After Crossover
Hide Description Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile). Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).
Time Frame Months 3, 6, 9, 12 after crossover
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.
Arm/Group Title Crossed Over to Pasireotide LAR (Extension) Crossed Over to Octreotide LAR (Extension)
Hide Arm/Group Description:
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
Overall Number of Participants Analyzed 81 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
M3 after crossover
49.4
(38.1 to 60.7)
28.9
(15.4 to 45.9)
M6 after crossover
43.2
(32.2 to 54.7)
31.6
(17.5 to 48.7)
M9 after crossover
54.3
(42.9 to 65.4)
31.6
(17.5 to 48.7)
M12 after crossover
44.4
(33.4 to 55.9)
23.7
(11.4 to 40.2)
20.Secondary Outcome
Title Percentage of Participants With Normalization of IGF-1 After Crossover
Hide Description Percentage of participants with normalization of sex- and age-adjusted IGF-1. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).
Time Frame Months 3, 6, 9, 12 after crossover
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.
Arm/Group Title Crossed Over to Pasireotide LAR (Extension) Crossed Over to Octreotide LAR (Extension)
Hide Arm/Group Description:
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
Overall Number of Participants Analyzed 81 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
M3 after crossover
19.8
(11.7 to 30.1)
7.9
(1.7 to 21.4)
M6 after crossover
30.9
(21.1 to 42.1)
7.9
(1.7 to 21.4)
M9 after crossover
29.6
(20.0 to 40.8)
10.5
(2.9 to 24.8)
M12 after crossover
27.2
(17.9 to 38.2)
5.3
(0.6 to 17.7)
21.Secondary Outcome
Title Summary of Mean GH Values After Crossover
Hide Description Mean GH levels (based on a 5-point profile over 2 hours). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over).
Time Frame Extension baseline, months 3, 6, 9, 12 after crossover
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.
Arm/Group Title Crossed Over to Pasireotide LAR (Extension) Crossed Over to Octreotide LAR (Extension)
Hide Arm/Group Description:
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
Overall Number of Participants Analyzed 81 38
Mean (Standard Deviation)
Unit of Measure: μg/L
Ext. Baseline Number Analyzed 78 participants 33 participants
5.9  (15.02) 7.1  (9.80)
M3 after crossover Number Analyzed 72 participants 36 participants
5.9  (19.70) 9.8  (17.09)
M6 after crossover Number Analyzed 68 participants 32 participants
4.8  (14.51) 9.8  (20.49)
M9 after crossover Number Analyzed 61 participants 32 participants
2.6  (3.03) 8.7  (19.26)
M12 after crossover Number Analyzed 57 participants 29 participants
2.5  (2.47) 10.4  (26.00)
22.Secondary Outcome
Title Change From Extension Baseline in Tumor Volume After Crossover
Hide Description

Percentage change from extension baseline in tumor volume (assessed by pituitary MRI).

Extension baseline was defined as last assessment prior to the administration of the new treatment after crossover. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over).

Time Frame Extension baseline, months 6, 12 after crossover
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.
Arm/Group Title Crossed Over to Pasireotide LAR (Extension) Crossed Over to Octreotide LAR (Extension)
Hide Arm/Group Description:
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
Overall Number of Participants Analyzed 81 38
Mean (Standard Deviation)
Unit of Measure: mm^3
Ext. Baseline Number Analyzed 73 participants 32 participants
1420.9  (1914.58) 1809.6  (2579.25)
Value at M6 after crossover Number Analyzed 65 participants 31 participants
1027.5  (1282.42) 1794.9  (2823.08)
% change - M6 after crossover Number Analyzed 59 participants 27 participants
-18.1  (17.68) -12.3  (24.11)
Value at M12 after crossover Number Analyzed 51 participants 30 participants
949.0  (1169.49) 1610.4  (2666.66)
% change - M12 after crossover Number Analyzed 46 participants 26 participants
-24.7  (25.20) -17.9  (27.80)
23.Secondary Outcome
Title Severity Scores of Acromegaly Symptoms After Crossover
Hide Description

Severity scores of acromegaly symptoms (Headache, Fatigue, Perspiration, Paresthesias, Osteoarthralgia).

Symptoms were scored from 0 (no symptom) to 4 (very severe). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over).

Time Frame Extension baseline, month 12 after crossover
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.
Arm/Group Title Crossed Over to Pasireotide LAR (Extension) Crossed Over to Octreotide LAR (Extension)
Hide Arm/Group Description:
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
Overall Number of Participants Analyzed 81 38
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Headache: Ext. BL Number Analyzed 81 participants 38 participants
0.6  (0.89) 0.4  (0.60)
Headache: M12 after crossover Number Analyzed 60 participants 32 participants
0.5  (0.83) 0.7  (0.79)
Fatigue: Ext. BL Number Analyzed 81 participants 38 participants
0.8  (1.07) 0.7  (0.76)
Fatigue: M12 after crossover Number Analyzed 60 participants 32 participants
0.8  (0.91) 0.7  (0.68)
Perspiration: Ext. BL Number Analyzed 81 participants 38 participants
0.5  (0.85) 0.6  (0.86)
Perspiration: M12 after crossover Number Analyzed 60 participants 32 participants
0.6  (0.98) 0.5  (0.80)
Paresthesia: Ext. BL Number Analyzed 81 participants 38 participants
0.4  (0.75) 0.4  (.054)
Paresthesia: M12 after crossover Number Analyzed 60 participants 32 participants
0.3  (0.56) 0.4  (0.76)
Osteoarthralgia: Ext. BL Number Analyzed 81 participants 38 participants
0.6  (0.91) 0.6  (0.79)
Osteoarthralgia: M12 after crossover Number Analyzed 60 participants 32 participants
0.5  (0.89) 0.7  (0.86)
24.Secondary Outcome
Title Ring Size After Crossover
Hide Description Ring size (based on jeweler’s finger gauge). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). BL = baseline, LH = left hand, RH = right hand, CO = crossover
Time Frame Extension baseline, month 12 after crossover
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Hide Analysis Population Description
CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received. In the extension baseline, no participant had ring size on their right hand measured at the 5th digit, hence no data.
Arm/Group Title Crossed Over to Pasireotide LAR (Extension) Crossed Over to Octreotide LAR (Extension)
Hide Arm/Group Description:
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
Overall Number of Participants Analyzed 81 38
Mean (Standard Deviation)
Unit of Measure: ring size
Ext. BL LH 4th digit Number Analyzed 55 participants 26 participants
11.2  (2.10) 11.0  (1.87)
Ext. BL LH 5th digit Number Analyzed 6 participants 5 participants
11.6  (1.88) 12.3  (2.46)
Ext. BL RH 4th digit Number Analyzed 15 participants 7 participants
11.4  (2.42) 12.4  (2.11)
Ext. BL RH 5th digit Number Analyzed 3 participants 0 participants
10.7  (2.31)
M12 after CO LH 4th digit Number Analyzed 42 participants 24 participants
10.9  (2.27) 11.2  (2.01)
M12 after CO LH 5th digit CO Number Analyzed 4 participants 4 participants
11.9  (2.14) 12.5  (1.35)
M12 after CO RH 4th digit Number Analyzed 11 participants 4 participants
11.6  (2.95) 11.4  (2.56)
M12 after CO RH 5th digit Number Analyzed 2 participants 0 participants
11.5  (0.00)
25.Secondary Outcome
Title Health-related Quality-of-life as Measured by the AcroQoL Questionnaire After Crossover
Hide Description AcroQoL total scores. The AcroQoL questionnaire is unidimensional and contains 22 items divided in two scales: one that evaluates physical aspects (eight items) and another one that evaluates psychological aspects (14 items). The scoring of the questionnaire was performed as specified by the instrument developers. Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Total scores range from 0 to 100. Higher scores represent better quality of life.
Time Frame Extension baseline, months 12 after crossover
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Hide Analysis Population Description
CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.
Arm/Group Title Crossed Over to Pasireotide LAR (Extension) Crossed Over to Octreotide LAR (Extension)
Hide Arm/Group Description:
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
Overall Number of Participants Analyzed 81 38
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Ext. Baseline Number Analyzed 79 participants 34 participants
58.9  (23.11) 59.8  (22.40)
M12 after crossover Number Analyzed 57 participants 30 participants
60.3  (24.34) 61.2  (21.62)
26.Secondary Outcome
Title Summary of Prolactin Levels After Crossover
Hide Description Prolactin (PRL) levels. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Extension baseline was defined as last measurement prior to the start of crossover treatment.
Time Frame Extension baseline, month 12 after crossover
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Hide Analysis Population Description
CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.
Arm/Group Title Crossed Over to Pasireotide LAR (Extension) Crossed Over to Octreotide LAR (Extension)
Hide Arm/Group Description:
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
Overall Number of Participants Analyzed 81 38
Mean (Standard Deviation)
Unit of Measure: μg/L
Ext. Baseline Number Analyzed 78 participants 34 participants
11.9  (18.42) 15.7  (36.76)
M12 after crossover Number Analyzed 60 participants 31 participants
7.5  (8.95) 16.1  (25.37)
Time Frame [Not Specified]
Adverse Event Reporting Description

Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp.

Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.

 
Arm/Group Title Pasireotide LAR - up to 26 Months Octreotide LAR - up to 26 Months Crossed Over to Pasireotide LAR - up to 26 Months Crossed Over to Octreotide LAR - up to 26 Months Pasireotide LAR - up to EOS Crossed Over to Pasireotide LAR - up to EOS
Hide Arm/Group Description Includes data from both blinded core and extension phase (up to Month 26 cutoff date of 29-Dec-2011) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment, only data collected before crossover is included. Includes data from both blinded core and extension phase (up to Month 26 cutoff date of 29-Dec-2011) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment, only data collected before crossover is included. Includes all data in the extension phase (up to 26-Month cutoff date of 29-Dec-2011) collected after the crossover time point for patients who crossed over from Octreotide LAR in the core to Pasireotide LAR treatment in the extension phase. Includes all data in the extension phase (up to 26-Month cutoff date of 29-Dec-2011) collected after the crossover time point for patients who crossed over from Pasireotide LAR in the core to Octreotide LAR treatment in the extension phase.

Includes data from both core and extension phase (up to End-of-study date of 11-Mar-2016) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment, only data collected before crossover is included.

Per protocol, patients on Pasireotide LAR could continue to receive open-label Pasireotide LAR after treatment unblinding at Month 26, whereas those on Octreotide LAR were not followed after Month 26.

Includes all data in the extension phase (up to End-of-study date of 11-Mar-2016) collected after the crossover time point for patients who crossed over from Octreotide LAR in the core to Pasireotide LAR treatment in the extension phase.

Per protocol, patients on Pasireotide LAR could continue to receive open-label Pasireotide LAR after treatment unblinding at Month 26, whereas those on Octreotide LAR were not followed after Month 26.

All-Cause Mortality
Pasireotide LAR - up to 26 Months Octreotide LAR - up to 26 Months Crossed Over to Pasireotide LAR - up to 26 Months Crossed Over to Octreotide LAR - up to 26 Months Pasireotide LAR - up to EOS Crossed Over to Pasireotide LAR - up to EOS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pasireotide LAR - up to 26 Months Octreotide LAR - up to 26 Months Crossed Over to Pasireotide LAR - up to 26 Months Crossed Over to Octreotide LAR - up to 26 Months Pasireotide LAR - up to EOS Crossed Over to Pasireotide LAR - up to EOS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   35/178 (19.66%)   28/180 (15.56%)   8/81 (9.88%)   6/38 (15.79%)   37/178 (20.79%)   12/81 (14.81%) 
Blood and lymphatic system disorders             
Neutropenia  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Cardiac disorders             
Acute myocardial infarction  1  0/178 (0.00%)  0/180 (0.00%)  0/81 (0.00%)  1/38 (2.63%)  0/178 (0.00%)  0/81 (0.00%) 
Angina unstable  1  0/178 (0.00%)  0/180 (0.00%)  0/81 (0.00%)  1/38 (2.63%)  0/178 (0.00%)  0/81 (0.00%) 
Atrial fibrillation  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Cardiac arrest  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Cardiovascular disorder  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Myocardial infarction  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Myocardial ischaemia  1  0/178 (0.00%)  0/180 (0.00%)  0/81 (0.00%)  1/38 (2.63%)  0/178 (0.00%)  0/81 (0.00%) 
Ear and labyrinth disorders             
Hypoacusis  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Endocrine disorders             
Acromegaly  1  2/178 (1.12%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  2/178 (1.12%)  0/81 (0.00%) 
Adrenal insufficiency  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Toxic nodular goitre  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Gastrointestinal disorders             
Abdominal pain  1  0/178 (0.00%)  1/180 (0.56%)  1/81 (1.23%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Abdominal pain upper  1  0/178 (0.00%)  2/180 (1.11%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Anal fissure  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Colitis  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Constipation  1  0/178 (0.00%)  0/180 (0.00%)  1/81 (1.23%)  0/38 (0.00%)  0/178 (0.00%)  2/81 (2.47%) 
Diarrhoea  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Gastritis  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Haemorrhoids  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Intestinal obstruction  1  0/178 (0.00%)  1/180 (0.56%)  1/81 (1.23%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Irritable bowel syndrome  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Large intestine polyp  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Nausea  1  0/178 (0.00%)  0/180 (0.00%)  1/81 (1.23%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Oesophageal obstruction  1  0/178 (0.00%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Pancreatic cyst  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Pancreatitis acute  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Vomiting  1  0/178 (0.00%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
General disorders             
Chills  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Concomitant disease progression  1  2/178 (1.12%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  2/178 (1.12%)  0/81 (0.00%) 
Fatigue  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Hernia  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Multi-organ failure  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Oedema peripheral  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Pyrexia  1  0/178 (0.00%)  1/180 (0.56%)  1/81 (1.23%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Hepatobiliary disorders             
Cholecystitis  1  2/178 (1.12%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  2/178 (1.12%)  0/81 (0.00%) 
Cholecystitis acute  1  2/178 (1.12%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  3/178 (1.69%)  0/81 (0.00%) 
Cholelithiasis  1  5/178 (2.81%)  4/180 (2.22%)  2/81 (2.47%)  1/38 (2.63%)  5/178 (2.81%)  3/81 (3.70%) 
Hydrocholecystis  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Infections and infestations             
Appendicitis  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Febrile infection  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Gastroenteritis  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Influenza  1  0/178 (0.00%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Pneumonia bacterial  1  0/178 (0.00%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Pyelonephritis  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Rectal abscess  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Renal abscess  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Septic shock  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Tonsillitis  1  0/178 (0.00%)  0/180 (0.00%)  1/81 (1.23%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Urinary tract infection  1  1/178 (0.56%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Injury, poisoning and procedural complications             
Back injury  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Brain contusion  1  0/178 (0.00%)  0/180 (0.00%)  1/81 (1.23%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Contusion  1  0/178 (0.00%)  0/180 (0.00%)  1/81 (1.23%)  0/38 (0.00%)  1/178 (0.56%)  1/81 (1.23%) 
Facial bones fracture  1  0/178 (0.00%)  0/180 (0.00%)  1/81 (1.23%)  0/38 (0.00%)  1/178 (0.56%)  1/81 (1.23%) 
Fibula fracture  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Head injury  1  0/178 (0.00%)  0/180 (0.00%)  1/81 (1.23%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Jaw fracture  1  0/178 (0.00%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Kidney rupture  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Ligament sprain  1  0/178 (0.00%)  0/180 (0.00%)  0/81 (0.00%)  1/38 (2.63%)  0/178 (0.00%)  0/81 (0.00%) 
Post-traumatic neck syndrome  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Rib fracture  1  0/178 (0.00%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Road traffic accident  1  1/178 (0.56%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Spinal column injury  1  0/178 (0.00%)  0/180 (0.00%)  1/81 (1.23%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Subdural haematoma  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Thoracic vertebral fracture  1  0/178 (0.00%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Tibia fracture  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Investigations             
Blood creatine phosphokinase increased  1  1/178 (0.56%)  2/180 (1.11%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Blood creatinine increased  1  0/178 (0.00%)  0/180 (0.00%)  1/81 (1.23%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Blood sodium decreased  1  0/178 (0.00%)  0/180 (0.00%)  1/81 (1.23%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Weight decreased  1  0/178 (0.00%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Metabolism and nutrition disorders             
Decreased appetite  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Diabetes mellitus  1  3/178 (1.69%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  3/178 (1.69%)  0/81 (0.00%) 
Diabetic ketoacidosis  1  0/178 (0.00%)  0/180 (0.00%)  1/81 (1.23%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Hyperglycaemia  1  1/178 (0.56%)  0/180 (0.00%)  1/81 (1.23%)  0/38 (0.00%)  1/178 (0.56%)  1/81 (1.23%) 
Hyperlipidaemia  1  0/178 (0.00%)  0/180 (0.00%)  1/81 (1.23%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Hypoglycaemia  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Hyponatraemia  1  0/178 (0.00%)  0/180 (0.00%)  0/81 (0.00%)  1/38 (2.63%)  0/178 (0.00%)  0/81 (0.00%) 
Type 2 diabetes mellitus  1  0/178 (0.00%)  0/180 (0.00%)  1/81 (1.23%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Back pain  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Chondritis  1  0/178 (0.00%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Intervertebral disc protrusion  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Musculoskeletal pain  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Osteoarthritis  1  1/178 (0.56%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  2/178 (1.12%)  0/81 (0.00%) 
Pain in extremity  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Pathological fracture  1  0/178 (0.00%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Tendonitis  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Acute myeloid leukaemia  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Benign breast neoplasm  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Cervix carcinoma  1  0/178 (0.00%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Hypopharyngeal neoplasm  1  0/178 (0.00%)  0/180 (0.00%)  1/81 (1.23%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Invasive ductal breast carcinoma  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Lipoma  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Mixed hepatocellular cholangiocarcinoma  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Papillary thyroid cancer  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Pituitary tumour benign  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Plasma cell myeloma  1  0/178 (0.00%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Renal oncocytoma  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Respiratory papilloma  1  0/178 (0.00%)  0/180 (0.00%)  1/81 (1.23%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Nervous system disorders             
Diabetic hyperglycaemic coma  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Dizziness  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Migraine  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Multiple sclerosis  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Seizure  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Pregnancy, puerperium and perinatal conditions             
Abortion spontaneous  1  0/178 (0.00%)  0/180 (0.00%)  0/81 (0.00%)  1/38 (2.63%)  0/178 (0.00%)  0/81 (0.00%) 
Psychiatric disorders             
Catatonia  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Completed suicide  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Major depression  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Renal and urinary disorders             
Acute kidney injury  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Hydronephrosis  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Nephrolithiasis  1  2/178 (1.12%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  2/178 (1.12%)  0/81 (0.00%) 
Urinary incontinence  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Reproductive system and breast disorders             
Breast mass  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Uterine prolapse  1  1/178 (0.56%)  0/180 (0.00%)  0/81 (0.00%)  0/38 (0.00%)  1/178 (0.56%)  0/81 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Lung infiltration  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Nasal polyps  1  0/178 (0.00%)  0/180 (0.00%)  1/81 (1.23%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Pulmonary mass  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Skin and subcutaneous tissue disorders             
Chronic pigmented purpura  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Vascular disorders             
Aortic aneurysm rupture  1  0/178 (0.00%)  0/180 (0.00%)  1/81 (1.23%)  0/38 (0.00%)  0/178 (0.00%)  1/81 (1.23%) 
Arteriovenous fistula  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Hypertension  1  0/178 (0.00%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  0/178 (0.00%)  0/81 (0.00%) 
Peripheral venous disease  1  0/178 (0.00%)  0/180 (0.00%)  0/81 (0.00%)  1/38 (2.63%)  0/178 (0.00%)  0/81 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pasireotide LAR - up to 26 Months Octreotide LAR - up to 26 Months Crossed Over to Pasireotide LAR - up to 26 Months Crossed Over to Octreotide LAR - up to 26 Months Pasireotide LAR - up to EOS Crossed Over to Pasireotide LAR - up to EOS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   169/178 (94.94%)   161/180 (89.44%)   74/81 (91.36%)   33/38 (86.84%)   170/178 (95.51%)   76/81 (93.83%) 
Blood and lymphatic system disorders             
Anaemia  1  14/178 (7.87%)  10/180 (5.56%)  6/81 (7.41%)  1/38 (2.63%)  19/178 (10.67%)  8/81 (9.88%) 
Cardiac disorders             
Sinus bradycardia  1  13/178 (7.30%)  10/180 (5.56%)  2/81 (2.47%)  1/38 (2.63%)  15/178 (8.43%)  3/81 (3.70%) 
Eye disorders             
Cataract  1  0/178 (0.00%)  1/180 (0.56%)  1/81 (1.23%)  2/38 (5.26%)  0/178 (0.00%)  1/81 (1.23%) 
Gastrointestinal disorders             
Abdominal discomfort  1  8/178 (4.49%)  1/180 (0.56%)  0/81 (0.00%)  0/38 (0.00%)  10/178 (5.62%)  0/81 (0.00%) 
Abdominal distension  1  21/178 (11.80%)  22/180 (12.22%)  0/81 (0.00%)  2/38 (5.26%)  21/178 (11.80%)  0/81 (0.00%) 
Abdominal pain  1  33/178 (18.54%)  43/180 (23.89%)  3/81 (3.70%)  1/38 (2.63%)  36/178 (20.22%)  4/81 (4.94%) 
Abdominal pain upper  1  12/178 (6.74%)  17/180 (9.44%)  3/81 (3.70%)  0/38 (0.00%)  14/178 (7.87%)  4/81 (4.94%) 
Constipation  1  10/178 (5.62%)  19/180 (10.56%)  4/81 (4.94%)  1/38 (2.63%)  13/178 (7.30%)  5/81 (6.17%) 
Diarrhoea  1  70/178 (39.33%)  79/180 (43.89%)  20/81 (24.69%)  6/38 (15.79%)  72/178 (40.45%)  26/81 (32.10%) 
Dyspepsia  1  8/178 (4.49%)  7/180 (3.89%)  3/81 (3.70%)  1/38 (2.63%)  9/178 (5.06%)  4/81 (4.94%) 
Flatulence  1  10/178 (5.62%)  11/180 (6.11%)  0/81 (0.00%)  0/38 (0.00%)  11/178 (6.18%)  0/81 (0.00%) 
Gastrooesophageal reflux disease  1  2/178 (1.12%)  2/180 (1.11%)  2/81 (2.47%)  2/38 (5.26%)  2/178 (1.12%)  2/81 (2.47%) 
Large intestine polyp  1  1/178 (0.56%)  0/180 (0.00%)  2/81 (2.47%)  2/38 (5.26%)  1/178 (0.56%)  2/81 (2.47%) 
Nausea  1  27/178 (15.17%)  41/180 (22.78%)  8/81 (9.88%)  2/38 (5.26%)  29/178 (16.29%)  10/81 (12.35%) 
Vomiting  1  19/178 (10.67%)  15/180 (8.33%)  3/81 (3.70%)  1/38 (2.63%)  22/178 (12.36%)  4/81 (4.94%) 
General disorders             
Fatigue  1  20/178 (11.24%)  21/180 (11.67%)  6/81 (7.41%)  3/38 (7.89%)  21/178 (11.80%)  7/81 (8.64%) 
Injection site pain  1  13/178 (7.30%)  9/180 (5.00%)  0/81 (0.00%)  1/38 (2.63%)  14/178 (7.87%)  0/81 (0.00%) 
Pyrexia  1  8/178 (4.49%)  10/180 (5.56%)  1/81 (1.23%)  0/38 (0.00%)  11/178 (6.18%)  2/81 (2.47%) 
Hepatobiliary disorders             
Biliary dilatation  1  5/178 (2.81%)  8/180 (4.44%)  4/81 (4.94%)  1/38 (2.63%)  5/178 (2.81%)  5/81 (6.17%) 
Cholelithiasis  1  56/178 (31.46%)  69/180 (38.33%)  18/81 (22.22%)  6/38 (15.79%)  59/178 (33.15%)  23/81 (28.40%) 
Gallbladder polyp  1  5/178 (2.81%)  3/180 (1.67%)  4/81 (4.94%)  2/38 (5.26%)  8/178 (4.49%)  5/81 (6.17%) 
Hepatic steatosis  1  10/178 (5.62%)  11/180 (6.11%)  6/81 (7.41%)  3/38 (7.89%)  11/178 (6.18%)  6/81 (7.41%) 
Infections and infestations             
Bronchitis  1  10/178 (5.62%)  4/180 (2.22%)  0/81 (0.00%)  0/38 (0.00%)  13/178 (7.30%)  2/81 (2.47%) 
Influenza  1  16/178 (8.99%)  11/180 (6.11%)  3/81 (3.70%)  3/38 (7.89%)  18/178 (10.11%)  4/81 (4.94%) 
Nasopharyngitis  1  32/178 (17.98%)  29/180 (16.11%)  13/81 (16.05%)  7/38 (18.42%)  34/178 (19.10%)  15/81 (18.52%) 
Sinusitis  1  6/178 (3.37%)  6/180 (3.33%)  2/81 (2.47%)  1/38 (2.63%)  9/178 (5.06%)  3/81 (3.70%) 
Upper respiratory tract infection  1  16/178 (8.99%)  7/180 (3.89%)  3/81 (3.70%)  2/38 (5.26%)  20/178 (11.24%)  5/81 (6.17%) 
Urinary tract infection  1  9/178 (5.06%)  12/180 (6.67%)  5/81 (6.17%)  0/38 (0.00%)  11/178 (6.18%)  10/81 (12.35%) 
Investigations             
Alanine aminotransferase increased  1  15/178 (8.43%)  10/180 (5.56%)  3/81 (3.70%)  0/38 (0.00%)  16/178 (8.99%)  5/81 (6.17%) 
Aspartate aminotransferase increased  1  12/178 (6.74%)  8/180 (4.44%)  3/81 (3.70%)  0/38 (0.00%)  13/178 (7.30%)  5/81 (6.17%) 
Blood bilirubin increased  1  9/178 (5.06%)  5/180 (2.78%)  1/81 (1.23%)  1/38 (2.63%)  11/178 (6.18%)  3/81 (3.70%) 
Blood creatine phosphokinase increased  1  25/178 (14.04%)  24/180 (13.33%)  7/81 (8.64%)  6/38 (15.79%)  27/178 (15.17%)  8/81 (9.88%) 
Blood glucose increased  1  17/178 (9.55%)  6/180 (3.33%)  8/81 (9.88%)  0/38 (0.00%)  18/178 (10.11%)  8/81 (9.88%) 
Blood thyroid stimulating hormone decreased  1  4/178 (2.25%)  2/180 (1.11%)  1/81 (1.23%)  2/38 (5.26%)  5/178 (2.81%)  1/81 (1.23%) 
Blood triglycerides increased  1  4/178 (2.25%)  4/180 (2.22%)  2/81 (2.47%)  4/38 (10.53%)  8/178 (4.49%)  2/81 (2.47%) 
Blood uric acid increased  1  6/178 (3.37%)  3/180 (1.67%)  1/81 (1.23%)  0/38 (0.00%)  10/178 (5.62%)  2/81 (2.47%) 
Electrocardiogram QT prolonged  1  9/178 (5.06%)  10/180 (5.56%)  3/81 (3.70%)  0/38 (0.00%)  10/178 (5.62%)  4/81 (4.94%) 
Gamma-glutamyltransferase increased  1  3/178 (1.69%)  11/180 (6.11%)  1/81 (1.23%)  0/38 (0.00%)  3/178 (1.69%)  2/81 (2.47%) 
Glycosylated haemoglobin increased  1  11/178 (6.18%)  5/180 (2.78%)  7/81 (8.64%)  0/38 (0.00%)  12/178 (6.74%)  9/81 (11.11%) 
Insulin-like growth factor decreased  1  1/178 (0.56%)  0/180 (0.00%)  1/81 (1.23%)  0/38 (0.00%)  2/178 (1.12%)  5/81 (6.17%) 
Lipase increased  1  10/178 (5.62%)  13/180 (7.22%)  3/81 (3.70%)  2/38 (5.26%)  11/178 (6.18%)  3/81 (3.70%) 
Weight decreased  1  9/178 (5.06%)  8/180 (4.44%)  2/81 (2.47%)  0/38 (0.00%)  9/178 (5.06%)  5/81 (6.17%) 
Metabolism and nutrition disorders             
Diabetes mellitus  1  38/178 (21.35%)  8/180 (4.44%)  18/81 (22.22%)  3/38 (7.89%)  40/178 (22.47%)  19/81 (23.46%) 
Glucose tolerance impaired  1  3/178 (1.69%)  1/180 (0.56%)  5/81 (6.17%)  0/38 (0.00%)  3/178 (1.69%)  5/81 (6.17%) 
Hypercholesterolaemia  1  7/178 (3.93%)  4/180 (2.22%)  2/81 (2.47%)  1/38 (2.63%)  10/178 (5.62%)  2/81 (2.47%) 
Hyperglycaemia  1  55/178 (30.90%)  18/180 (10.00%)  25/81 (30.86%)  5/38 (13.16%)  56/178 (31.46%)  29/81 (35.80%) 
Hyperlipidaemia  1  5/178 (2.81%)  4/180 (2.22%)  5/81 (6.17%)  2/38 (5.26%)  5/178 (2.81%)  5/81 (6.17%) 
Hyperuricaemia  1  5/178 (2.81%)  2/180 (1.11%)  1/81 (1.23%)  0/38 (0.00%)  9/178 (5.06%)  2/81 (2.47%) 
Hypoglycaemia  1  11/178 (6.18%)  14/180 (7.78%)  7/81 (8.64%)  2/38 (5.26%)  14/178 (7.87%)  8/81 (9.88%) 
Type 2 diabetes mellitus  1  12/178 (6.74%)  0/180 (0.00%)  3/81 (3.70%)  0/38 (0.00%)  12/178 (6.74%)  4/81 (4.94%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  21/178 (11.80%)  25/180 (13.89%)  10/81 (12.35%)  2/38 (5.26%)  24/178 (13.48%)  14/81 (17.28%) 
Back pain  1  22/178 (12.36%)  21/180 (11.67%)  6/81 (7.41%)  3/38 (7.89%)  24/178 (13.48%)  8/81 (9.88%) 
Muscle spasms  1  8/178 (4.49%)  10/180 (5.56%)  7/81 (8.64%)  1/38 (2.63%)  10/178 (5.62%)  8/81 (9.88%) 
Musculoskeletal pain  1  7/178 (3.93%)  3/180 (1.67%)  1/81 (1.23%)  1/38 (2.63%)  9/178 (5.06%)  2/81 (2.47%) 
Osteoarthritis  1  4/178 (2.25%)  4/180 (2.22%)  1/81 (1.23%)  2/38 (5.26%)  4/178 (2.25%)  2/81 (2.47%) 
Pain in extremity  1  14/178 (7.87%)  8/180 (4.44%)  6/81 (7.41%)  1/38 (2.63%)  16/178 (8.99%)  6/81 (7.41%) 
Nervous system disorders             
Dizziness  1  21/178 (11.80%)  20/180 (11.11%)  7/81 (8.64%)  4/38 (10.53%)  22/178 (12.36%)  9/81 (11.11%) 
Headache  1  41/178 (23.03%)  49/180 (27.22%)  17/81 (20.99%)  5/38 (13.16%)  42/178 (23.60%)  20/81 (24.69%) 
Paraesthesia  1  8/178 (4.49%)  4/180 (2.22%)  0/81 (0.00%)  1/38 (2.63%)  9/178 (5.06%)  0/81 (0.00%) 
Psychiatric disorders             
Anxiety  1  9/178 (5.06%)  7/180 (3.89%)  1/81 (1.23%)  0/38 (0.00%)  11/178 (6.18%)  2/81 (2.47%) 
Insomnia  1  8/178 (4.49%)  9/180 (5.00%)  2/81 (2.47%)  1/38 (2.63%)  12/178 (6.74%)  4/81 (4.94%) 
Renal and urinary disorders             
Haematuria  1  6/178 (3.37%)  2/180 (1.11%)  1/81 (1.23%)  2/38 (5.26%)  8/178 (4.49%)  2/81 (2.47%) 
Pyelocaliectasis  1  0/178 (0.00%)  0/180 (0.00%)  0/81 (0.00%)  2/38 (5.26%)  0/178 (0.00%)  0/81 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Cough  1  11/178 (6.18%)  17/180 (9.44%)  1/81 (1.23%)  1/38 (2.63%)  16/178 (8.99%)  3/81 (3.70%) 
Oropharyngeal pain  1  8/178 (4.49%)  15/180 (8.33%)  3/81 (3.70%)  1/38 (2.63%)  9/178 (5.06%)  4/81 (4.94%) 
Skin and subcutaneous tissue disorders             
Alopecia  1  34/178 (19.10%)  36/180 (20.00%)  3/81 (3.70%)  1/38 (2.63%)  34/178 (19.10%)  4/81 (4.94%) 
Vascular disorders             
Hypertension  1  18/178 (10.11%)  16/180 (8.89%)  5/81 (6.17%)  3/38 (7.89%)  21/178 (11.80%)  6/81 (7.41%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights 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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00600886     History of Changes
Other Study ID Numbers: CSOM230C2305
2007-001972-36 ( EudraCT Number )
First Submitted: January 14, 2008
First Posted: January 25, 2008
Results First Submitted: December 19, 2014
Results First Posted: January 30, 2015
Last Update Posted: July 2, 2017