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    Clinical Trial Results:
    A phase IIIb multicenter, open-label, single arm study to evaluate the efficacy and safety of pasireotide in patients with acromegaly inadequately controlled with first generation somatostatin analogues

    Summary
    EudraCT number
    		 2014-002630-31
    Trial protocol
    		 HU   BE   PT   IT   FR   BG  
    Global end of trial date
    27 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Oct 2019
    First version publication date
    12 Oct 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CSOM230C2413
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02354508
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma, AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Study Director, Novartis Pharma, AG, +41 613241111, novartis.email@novartis.com
    Scientific contact
    Study Director, Novartis Pharma, AG, +41 613241111, novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Sep 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of pasireotide LAR in patients with acromegaly who are inadequately controlled with maximal approved doses of currently available somatostatin analogues, as measured by the proportion of patients with GH <1μg/L and IGF-1 <ULN at week 36
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Mar 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 1
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Brazil: 10
    Country: Number of subjects enrolled
    Bulgaria: 4
    Country: Number of subjects enrolled
    China: 7
    Country: Number of subjects enrolled
    Colombia: 2
    Country: Number of subjects enrolled
    France: 14
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Hungary: 5
    Country: Number of subjects enrolled
    Italy: 14
    Country: Number of subjects enrolled
    Malaysia: 4
    Country: Number of subjects enrolled
    Mexico: 22
    Country: Number of subjects enrolled
    Portugal: 7
    Country: Number of subjects enrolled
    Romania: 9
    Country: Number of subjects enrolled
    Turkey: 12
    Worldwide total number of subjects
    123
    EEA total number of subjects
    65
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    115
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Planned 112 subjects and analyzed 123 subjects. For Disposition/Baseline Characteristics Tables, TOTAL = subjects in the Pasireotide LAR arm.

    Pre-assignment
    Screening details
    		 Subjects were allocated to Group 1 or Group 2 based on previously received first generation Somatostatin analog (SSA).

    Period 1
    Period 1 title
    Period 1 - Core Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lanreotide 120 mg
    Arm description
    		 Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pasireotide LAR
    Investigational medicinal product code
    SOM230
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    microparticles powder in vials containing nominally 40 and 60 mg of pasireotide (as free base) along with solvent for suspension for injection in ampules for the reconstitution of the LAR microparticles.

    Arm title
    		 Octreotide 30 mg
    Arm description
    		 Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pasireotide LAR
    Investigational medicinal product code
    SOM230
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    microparticles powder in vials containing nominally 40 and 60 mg of pasireotide (as free base) along with solvent for suspension for injection in ampules for the reconstitution of the LAR microparticles.

    Investigational medicinal product name
    Octreotide 40 mg
    Investigational medicinal product code
    SMS995
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    40 mg Octreotide LAR used during the run-in phase for patients in Group 1 (Octreotide LAR 30 mg group)

    Arm title
    		 Octreotide 40 mg
    Arm description
    		 Participants were treated with octreotide 40 mg and assigned to either Group 1 (if 40mg octreotide was approved in the country) or Group 2 if 40mg octreotide was not approved in the country (before starting on Pasireotide in the Core phase).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pasireotide LAR
    Investigational medicinal product code
    SOM230
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    microparticles powder in vials containing nominally 40 and 60 mg of pasireotide (as free base) along with solvent for suspension for injection in ampules for the reconstitution of the LAR microparticles.

    Number of subjects in period 1
    		Lanreotide 120 mg Octreotide 30 mg Octreotide 40 mg
    Started
    41
    29
    53
    Completed
    39
    27
    47
    Not completed
    2
    2
    6
         Consent withdrawn by subject
    -
    1
    2
         Adverse event, non-fatal
    1
    1
    2
         Unsatisfactory therapeutic effect
    1
    -
    2
    Period 2
    Period 2 title
    Period 2 - Extension Phase
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lanreotide 120 mg
    Arm description
    		 Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pasireotide LAR
    Investigational medicinal product code
    SOM230
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    microparticles powder in vials containing nominally 40 and 60 mg of pasireotide (as free base) along with solvent for suspension for injection in ampules for the reconstitution of the LAR microparticles.

    Arm title
    		 Octreotide 30 mg
    Arm description
    		 Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pasireotide LAR
    Investigational medicinal product code
    SOM230
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    microparticles powder in vials containing nominally 40 and 60 mg of pasireotide (as free base) along with solvent for suspension for injection in ampules for the reconstitution of the LAR microparticles.

    Investigational medicinal product name
    Octreotide 40 mg
    Investigational medicinal product code
    SMS995
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    40 mg Octreotide LAR used during the run-in phase for patients in Group 1 (Octreotide LAR 30 mg group)

    Arm title
    		 Octreotide 40 mg
    Arm description
    		 Participants were treated with octreotide 40 mg and assigned to either Group 1 (if 40mg octreotide was approved in the country) or Group 2 if 40mg octreotide was not approved in the country (before starting on Pasireotide in the Core phase).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pasireotide LAR
    Investigational medicinal product code
    SOM230
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    microparticles powder in vials containing nominally 40 and 60 mg of pasireotide (as free base) along with solvent for suspension for injection in ampules for the reconstitution of the LAR microparticles.

    Number of subjects in period 2 [1]
    		Lanreotide 120 mg Octreotide 30 mg Octreotide 40 mg
    Started
    26
    23
    39
    Completed
    20
    19
    36
    Not completed
    6
    4
    3
         Physician decision
    5
    -
    1
         Consent withdrawn by subject
    -
    1
    -
         Unsatisfactory therapeutic effect
    1
    3
    2
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: No statistical analysis was planned for this endpoint.
    Period 3
    Period 3 title
    Period 3 - Post-treatment follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lanreotide 120 mg
    Arm description
    		 Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pasireotide LAR
    Investigational medicinal product code
    SOM230
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    microparticles powder in vials containing nominally 40 and 60 mg of pasireotide (as free base) along with solvent for suspension for injection in ampules for the reconstitution of the LAR microparticles.

    Arm title
    		 Octreotide 30 mg
    Arm description
    		 Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pasireotide LAR
    Investigational medicinal product code
    SOM230
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    microparticles powder in vials containing nominally 40 and 60 mg of pasireotide (as free base) along with solvent for suspension for injection in ampules for the reconstitution of the LAR microparticles.

    Investigational medicinal product name
    Octreotide 40 mg
    Investigational medicinal product code
    SMS995
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    40 mg Octreotide LAR used during the run-in phase for patients in Group 1 (Octreotide LAR 30 mg group)

    Arm title
    		 Octreotide 40 mg
    Arm description
    		 Participants were treated with octreotide 40 mg and assigned to either Group 1 (if 40mg octreotide was approved in the country) or Group 2 if 40mg octreotide was not approved in the country (before starting on Pasireotide in the Core phase).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pasireotide LAR
    Investigational medicinal product code
    SOM230
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    microparticles powder in vials containing nominally 40 and 60 mg of pasireotide (as free base) along with solvent for suspension for injection in ampules for the reconstitution of the LAR microparticles.

    Number of subjects in period 3
    		Lanreotide 120 mg Octreotide 30 mg Octreotide 40 mg
    Started
    20
    19
    36
    Completed
    18
    17
    33
    Not completed
    4
    3
    3
         Physician decision
    3
    -
    1
         Consent withdrawn by subject
    -
    1
    -
         Unsatisfactory therapeutic effect
    1
    2
    2
    Joined
    2
    1
    0
         followed for safety
    2
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Lanreotide 120 mg
    Reporting group description
    		 Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).

    Reporting group title
    Octreotide 30 mg
    Reporting group description
    		 Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .

    Reporting group title
    Octreotide 40 mg
    Reporting group description
    		 Participants were treated with octreotide 40 mg and assigned to either Group 1 (if 40mg octreotide was approved in the country) or Group 2 if 40mg octreotide was not approved in the country (before starting on Pasireotide in the Core phase).

    Reporting group values
    		 Lanreotide 120 mg Octreotide 30 mg Octreotide 40 mg Total
    Number of subjects
    		 41 29 53 123
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 40 28 47 115
        From 65-84 years
    		 1 1 6 8
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.8 ( 10.02 ) 41.6 ( 12.89 ) 46.6 ( 11.63 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 19 18 25 62
        Male
    		 22 11 28 61
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 34 14 30 78
        Black
    		 0 1 0 1
        Asian
    		 1 7 3 11
        Native American
    		 2 0 1 3
        Other
    		 4 7 19 30
    Subject analysis sets

    Subject analysis set title
    Pasireotide LAR overall
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

    Subject analysis set title
    Up-titrated to Pasireotide LAR 60 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the subset of participants in the FAS who started treatment with 40 mg pasireotide LAR in the core phase and were up-titrated to pasireotide LAR 60 mg.

    Subject analysis set title
    Pasireotide LAR overall
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

    Subject analysis set title
    Pasireotide LAR monotherapy
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received pasireotide LAR only

    Subject analysis set title
    Pasireotide with concomitant medication
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received pasireotide along with other concomitant medications.or octreotide 40 mg.

    Subject analysis set title
    Pasireotide LAR overall
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

    Subject analysis set title
    Up-titrated to Pasireotide LAR 60 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the subset of participants in the Extension FAS who started treatment with 40 mg pasireotide LAR in the extension phase and were up-titrated to pasireotide LAR 60 mg.

    Subject analysis set title
    Pasireotide LAR (run-in phase)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were part of the run-in phase, i.e. group 1)

    Subject analysis set title
    GH: ≥ 1 - ≤ 2.5 μg/L at screening
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    These Participants had this GH level at screening

    Subject analysis set title
    GH: > 2.5 μg/L at screening
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    These Participants had this GH level at screening

    Subject analysis set title
    GH: Missing
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    These Participants were missing GH levels at screening

    Subject analysis set title
    Pasireotide LAR overall
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the total sum of participants with at screening with various or missing GH levels

    Subject analysis set title
    Diabetic
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were diabetic in the Pasireotide LAR overall group

    Subject analysis set title
    Pasireotide LAR overall - AcroQOL total scores
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

    Subject analysis set title
    Pasireotide LAR overall - AcroQOL physical sub-scores
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg

    Subject analysis set title
    Pasireotide LAR overall - AcroQOL psychological sub-scores
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

    Subject analysis set title
    Pasireotide LAR overall - AcroQOL psycho/appearance sub-scores
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg

    Subject analysis set title
    Pasireotide LAR overall-AcroQOL psycho/pers relatns sub-scores
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Headache
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Fatigue
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Perspiration
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Osteoarthralgia
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Paresthesiae
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Paresthsiae
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg

    Subject analysis set title
    Up-titrated to Pasireotide LAR 60 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the subset of participants in the FAS who started treatment with 40 mg pasireotide LAR in the core phase and were up-titrated to pasireotide LAR 60 mg.

    Subject analysis set title
    Pasireotide LAR overall
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    These are the participants in the extension phase who received Pasireotide LAR

    Subject analysis set title
    Pasireotide LAR monotherapy
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    These Participants were treated with pasireotide LAR only in the extension phase

    Subject analysis set title
    Pasireotide with concomitant mediaction
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    These Participants were treated with pasireotide LAR as well as other concomitant medications in the extension phase

    Subject analysis set title
    Pasireotide LAR overall
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall - AcroQOL total scores
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall - AcroQOL physical sub-scores
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall - AcroQOL psychological sub-scores
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall - AcroQOL psycho/appearance sub-scores
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall-AcroQOL psycho/pers relatns sub-scores
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Headache
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Fatigue
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Perspiration
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Osteoarthralgia
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Paresthesiae
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Paresthsiae
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pre-diabetic
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were pre-diabetic in the Pasireotide LAR overall group

    Subject analysis set title
    Non-diabetic
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were non-diabetic in the Pasireotide LAR overall group

    Subject analysis sets values
    		 Pasireotide LAR overall Up-titrated to Pasireotide LAR 60 mg Pasireotide LAR overall Pasireotide LAR monotherapy Pasireotide with concomitant medication Pasireotide LAR overall Up-titrated to Pasireotide LAR 60 mg Pasireotide LAR (run-in phase) GH: ≥ 1 - ≤ 2.5 μg/L at screening GH: > 2.5 μg/L at screening GH: Missing Pasireotide LAR overall Diabetic Pasireotide LAR overall - AcroQOL total scores Pasireotide LAR overall - AcroQOL physical sub-scores Pasireotide LAR overall - AcroQOL psychological sub-scores Pasireotide LAR overall - AcroQOL psycho/appearance sub-scores Pasireotide LAR overall-AcroQOL psycho/pers relatns sub-scores Pasireotide LAR overall - Acromegaly symptom: Headache Pasireotide LAR overall - Acromegaly symptom: Fatigue Pasireotide LAR overall - Acromegaly symptom: Perspiration Pasireotide LAR overall - Acromegaly symptom: Osteoarthralgia Pasireotide LAR overall - Acromegaly symptom: Paresthesiae Pasireotide LAR overall - Acromegaly symptom: Paresthsiae Up-titrated to Pasireotide LAR 60 mg Pasireotide LAR overall Pasireotide LAR monotherapy Pasireotide with concomitant mediaction Pasireotide LAR overall Pasireotide LAR overall - AcroQOL total scores Pasireotide LAR overall - AcroQOL physical sub-scores Pasireotide LAR overall - AcroQOL psychological sub-scores Pasireotide LAR overall - AcroQOL psycho/appearance sub-scores Pasireotide LAR overall-AcroQOL psycho/pers relatns sub-scores Pasireotide LAR overall - Acromegaly symptom: Headache Pasireotide LAR overall - Acromegaly symptom: Fatigue Pasireotide LAR overall - Acromegaly symptom: Perspiration Pasireotide LAR overall - Acromegaly symptom: Osteoarthralgia Pasireotide LAR overall - Acromegaly symptom: Paresthesiae Pasireotide LAR overall - Acromegaly symptom: Paresthsiae Pre-diabetic Non-diabetic
    Number of subjects
    123
    90
    102
    76
    12
    88
    70
    17
    28
    94
    1
    123
    52
    123
    123
    123
    123
    123
    123
    123
    123
    123
    123
    123
    70
    88
    76
    12
    88
    88
    88
    88
    88
    88
    88
    88
    88
    88
    88
    88
    60
    11
    Age categorical
    Units: Subjects
        Adults (18-64 years)
        From 65-84 years
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    14.6 ( )
    6.7 ( )
    15.7 ( )
    17.1 ( )
    0.0 ( )
    14.8 ( )
    5.9 ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Sex: Female, Male
    Units: Subjects
        Female
        Male
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
        Black
        Asian
        Native American
        Other

    End points

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    End points reporting groups
    Reporting group title
    Lanreotide 120 mg
    Reporting group description
    		 Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).

    Reporting group title
    Octreotide 30 mg
    Reporting group description
    		 Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .

    Reporting group title
    Octreotide 40 mg
    Reporting group description
    		 Participants were treated with octreotide 40 mg and assigned to either Group 1 (if 40mg octreotide was approved in the country) or Group 2 if 40mg octreotide was not approved in the country (before starting on Pasireotide in the Core phase).
    Reporting group title
    Lanreotide 120 mg
    Reporting group description
    		 Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).

    Reporting group title
    Octreotide 30 mg
    Reporting group description
    		 Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .

    Reporting group title
    Octreotide 40 mg
    Reporting group description
    		 Participants were treated with octreotide 40 mg and assigned to either Group 1 (if 40mg octreotide was approved in the country) or Group 2 if 40mg octreotide was not approved in the country (before starting on Pasireotide in the Core phase).
    Reporting group title
    Lanreotide 120 mg
    Reporting group description
    		 Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).

    Reporting group title
    Octreotide 30 mg
    Reporting group description
    		 Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .

    Reporting group title
    Octreotide 40 mg
    Reporting group description
    		 Participants were treated with octreotide 40 mg and assigned to either Group 1 (if 40mg octreotide was approved in the country) or Group 2 if 40mg octreotide was not approved in the country (before starting on Pasireotide in the Core phase).

    Subject analysis set title
    Pasireotide LAR overall
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

    Subject analysis set title
    Up-titrated to Pasireotide LAR 60 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the subset of participants in the FAS who started treatment with 40 mg pasireotide LAR in the core phase and were up-titrated to pasireotide LAR 60 mg.

    Subject analysis set title
    Pasireotide LAR overall
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

    Subject analysis set title
    Pasireotide LAR monotherapy
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received pasireotide LAR only

    Subject analysis set title
    Pasireotide with concomitant medication
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received pasireotide along with other concomitant medications.or octreotide 40 mg.

    Subject analysis set title
    Pasireotide LAR overall
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

    Subject analysis set title
    Up-titrated to Pasireotide LAR 60 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the subset of participants in the Extension FAS who started treatment with 40 mg pasireotide LAR in the extension phase and were up-titrated to pasireotide LAR 60 mg.

    Subject analysis set title
    Pasireotide LAR (run-in phase)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were part of the run-in phase, i.e. group 1)

    Subject analysis set title
    GH: ≥ 1 - ≤ 2.5 μg/L at screening
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    These Participants had this GH level at screening

    Subject analysis set title
    GH: > 2.5 μg/L at screening
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    These Participants had this GH level at screening

    Subject analysis set title
    GH: Missing
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    These Participants were missing GH levels at screening

    Subject analysis set title
    Pasireotide LAR overall
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the total sum of participants with at screening with various or missing GH levels

    Subject analysis set title
    Diabetic
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were diabetic in the Pasireotide LAR overall group

    Subject analysis set title
    Pasireotide LAR overall - AcroQOL total scores
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

    Subject analysis set title
    Pasireotide LAR overall - AcroQOL physical sub-scores
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg

    Subject analysis set title
    Pasireotide LAR overall - AcroQOL psychological sub-scores
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

    Subject analysis set title
    Pasireotide LAR overall - AcroQOL psycho/appearance sub-scores
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg

    Subject analysis set title
    Pasireotide LAR overall-AcroQOL psycho/pers relatns sub-scores
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Headache
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Fatigue
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Perspiration
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Osteoarthralgia
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Paresthesiae
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Paresthsiae
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg

    Subject analysis set title
    Up-titrated to Pasireotide LAR 60 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the subset of participants in the FAS who started treatment with 40 mg pasireotide LAR in the core phase and were up-titrated to pasireotide LAR 60 mg.

    Subject analysis set title
    Pasireotide LAR overall
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    These are the participants in the extension phase who received Pasireotide LAR

    Subject analysis set title
    Pasireotide LAR monotherapy
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    These Participants were treated with pasireotide LAR only in the extension phase

    Subject analysis set title
    Pasireotide with concomitant mediaction
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    These Participants were treated with pasireotide LAR as well as other concomitant medications in the extension phase

    Subject analysis set title
    Pasireotide LAR overall
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall - AcroQOL total scores
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall - AcroQOL physical sub-scores
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall - AcroQOL psychological sub-scores
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall - AcroQOL psycho/appearance sub-scores
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall-AcroQOL psycho/pers relatns sub-scores
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Headache
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Fatigue
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Perspiration
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Osteoarthralgia
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Paresthesiae
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pasireotide LAR overall - Acromegaly symptom: Paresthsiae
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

    Subject analysis set title
    Pre-diabetic
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were pre-diabetic in the Pasireotide LAR overall group

    Subject analysis set title
    Non-diabetic
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were non-diabetic in the Pasireotide LAR overall group

    Primary: Core phase: Proportion of participants with mean GH < 1 g/L and IGF-1 < ULN at Week 36 by previous treatment and overall

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    End point title
    		 Core phase: Proportion of participants with mean GH < 1 g/L and IGF-1 < ULN at Week 36 by previous treatment and overall [1]
    End point description
    Proportion of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 <ULN at week 36.
    End point type
    Primary
    End point timeframe
    Week 36
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint.
    End point values
    		 Lanreotide 120 mg Octreotide 30 mg Octreotide 40 mg Pasireotide LAR overall
    Number of subjects analysed
    41
    29
    53
    123
    Units: Percentage of participants
        number (confidence interval 95%)
    14.6 (5.57 to 29.17)
    13.8 (3.89 to 31.66)
    15.1 (6.75 to 27.59)
    14.6 (8.91 to 22.14)
    No statistical analyses for this end point

    Primary: Core phase: Proportion of participants with mean GH < 1 g/L and IGF-1 < ULN at Week 36 for participants up-titrated to pasireotide LAR 60 mg

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    End point title
    		 Core phase: Proportion of participants with mean GH < 1 g/L and IGF-1 < ULN at Week 36 for participants up-titrated to pasireotide LAR 60 mg [2]
    End point description
    Proportion of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 <ULN at week 36, for participants who had been up-titrated with pasireotide LAR 60 mg.
    End point type
    Primary
    End point timeframe
    Week 36
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint.
    End point values
    		 Up-titrated to Pasireotide LAR 60 mg
    Number of subjects analysed
    90
    Units: Percentage of participants
        number (confidence interval 95%)
    6.7 (2.49 to 13.95)
    No statistical analyses for this end point

    Primary: Core phase: Proportion of participants with mean GH < 1 g/L and IGF-1 < ULN at Week 36

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    End point title
    		 Core phase: Proportion of participants with mean GH < 1 g/L and IGF-1 < ULN at Week 36 [3]
    End point description
    Proportion of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 <ULN at week 36.
    End point type
    Primary
    End point timeframe
    Wek 36
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint.
    End point values
    		 Pasireotide LAR overall
    Number of subjects analysed
    102
    Units: Percentage of participants
        number (confidence interval 95%)
    15.7 (9.24 to 24.22)
    No statistical analyses for this end point

    Primary: Core phase: Proportion of participants with mean GH < 1 g/L and IGF-1 < ULN at Week 36

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    End point title
    		 Core phase: Proportion of participants with mean GH < 1 g/L and IGF-1 < ULN at Week 36 [4]
    End point description
    Proportion of patients who achieved biochemical control defined as GH <1μg/L and IGF-1 <ULN at week 36, by previous treatment, type of therapy and overall.
    End point type
    Primary
    End point timeframe
    Week 36
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint.
    End point values
    		 Lanreotide 120 mg Octreotide 30 mg Octreotide 40 mg Pasireotide LAR monotherapy Pasireotide with concomitant medication Pasireotide LAR overall
    Number of subjects analysed
    26
    23
    39
    76
    12
    88
    Units: Percentage of participants
        number (confidence interval 95%)
    7.7 (0.95 to 25.13)
    13.0 (2.78 to 33.59)
    20.5 (9.30 to 36.46)
    17.1 (9.43 to 27.47)
    0.0 (0.00 to 26.46)
    14.8 (8.11 to 23.94)
    No statistical analyses for this end point

    Primary: Core phase: Proportion of participants with mean GH < 1 g/L and IGF-1 < ULN at Week 36 for participants up-titrated to pasireotide LAR 60 mg

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    End point title
    		 Core phase: Proportion of participants with mean GH < 1 g/L and IGF-1 < ULN at Week 36 for participants up-titrated to pasireotide LAR 60 mg [5]
    End point description
    Proportion of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 <ULN at week 36, for participants who had been up-titrated with pasireotide LAR 60 mg.
    End point type
    Primary
    End point timeframe
    Week 36
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint.
    End point values
    		 Up-titrated to Pasireotide LAR 60 mg
    Number of subjects analysed
    70
    Units: Percentage of participants
        number (confidence interval 95%)
    5.9 (1.63 to 14.38)
    No statistical analyses for this end point

    Primary: Core phase: Proportion of participants with mean GH < 1 g/L and IGF-1 < ULN at Week 36 overall by baseline diabetic status

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    End point title
    		 Core phase: Proportion of participants with mean GH < 1 g/L and IGF-1 < ULN at Week 36 overall by baseline diabetic status [6]
    End point description
    Proportion of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 <ULN at week 36, overall by baseline diabetic status.
    End point type
    Primary
    End point timeframe
    Week 36
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint.
    End point values
    		 Pasireotide LAR overall
    Number of subjects analysed
    88
    Units: Percentage of participants
    number (confidence interval 95%)
        Diabetic
    14.0 (5.30 to 27.93)
        Pre-diabetic
    19.4 (8.19 to 36.02)
        Non-diabetic
    0.0 (0.00 to 33.63)
    No statistical analyses for this end point

    Primary: Core phase: Proportion of participants with mean GH < 1 g/L and IGF-1 < ULN at Week 36 by previous treatment and overall - LOCF

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    End point title
    		 Core phase: Proportion of participants with mean GH < 1 g/L and IGF-1 < ULN at Week 36 by previous treatment and overall - LOCF [7]
    End point description
    Proportion of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 <ULN at week 36, by previous treatment and overall - last observation carried forward (LOCF)
    End point type
    Primary
    End point timeframe
    Week 36
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint.
    End point values
    		 Lanreotide 120 mg Octreotide 30 mg Octreotide 40 mg Pasireotide LAR overall
    Number of subjects analysed
    41
    29
    53
    123
    Units: Percentage of participants
        number (confidence interval 95%)
    14.6 (5.57 to 29.17)
    13.8 (3.89 to 31.66)
    17.0 (8.07 to 29.80)
    15.4 (9.56 to 23.07)
    No statistical analyses for this end point

    Secondary: Core phase: Change in mean Growth Hormone (GH) values from baseline to week 36

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    End point title
    		 Core phase: Change in mean Growth Hormone (GH) values from baseline to week 36
    End point description
    Core phase - Changes in mean GH from study baseline to week 36.
    End point type
    Secondary
    End point timeframe
    baseline, week 36
    End point values
    		 Lanreotide 120 mg Octreotide 30 mg Octreotide 40 mg Pasireotide LAR overall
    Number of subjects analysed
    41
    29
    53
    123
    Units: percentage
        arithmetic mean (standard error)
    -7.7 ( 19.51 )
    -8.5 ( 24.41 )
    -39.8 ( 54.87 )
    -6.0 ( 17.10 )
    No statistical analyses for this end point

    Secondary: Core phase: Change in standardized IGF-1 values from baseline to Week 36

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    End point title
    		 Core phase: Change in standardized IGF-1 values from baseline to Week 36
    End point description
    Core phase - Changes in standardized IGF-1 from study baseline to week 36.
    End point type
    Secondary
    End point timeframe
    baseline, week 36
    End point values
    		 Lanreotide 120 mg Octreotide 30 mg Octreotide 40 mg Pasireotide LAR overall
    Number of subjects analysed
    41
    29
    53
    123
    Units: percentage
        arithmetic mean (standard deviation)
    -1.1 ( 1.8 )
    -0.8 ( 0.78 )
    -1.1 ( 1.39 )
    -1.0 ( 1.18 )
    No statistical analyses for this end point

    Secondary: Core phase: Proportion of participants with mean GH <1 μg/L and IGF-1 <ULN

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    End point title
    		 Core phase: Proportion of participants with mean GH <1 μg/L and IGF-1 <ULN
    End point description
    Proportion of participants achieving GH <1 μg/L and IGF-1 <ULN at weeks 12 and 24 overall and by GH level at screening.
    End point type
    Secondary
    End point timeframe
    Week 12, Week 24
    End point values
    		 Pasireotide LAR overall Pasireotide LAR (run-in phase)
    Number of subjects analysed
    123
    17
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 12: GH: ≥ 1 - ≤ 2.5 μg/L at screening
    28.6 (13.22 to 48.67)
    25.0 (0.63 to 80.59)
        Week 24: GH: ≥ 1 - ≤ 2.5 μg/L at screening
    39.3 (21.50 to 59.42)
    25.0 (0.63 to 80.59)
        Week 12: GH: > 2.5 μg/L at screening
    5.3 (1.75 to 11.98)
    7.7 (0.19 to 36.03)
        Week 24: GH: > 2.5 μg/L at screening
    5.3 (1.75 to 11.98)
    7.7 (0.19 to 36.03)
        Week 12: GH: Missing
    0.0 (0.00 to 97.50)
    0.0 (0.00 to 0.00)
        Week 24: GH: Missing
    0.0 (0.00 to 97.50)
    0.0 (0.00 to 0.00)
    No statistical analyses for this end point

    Secondary: Core phase: Proportion of participants with IGF-1 <ULN overall by GH level at screening

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    End point title
    		 Core phase: Proportion of participants with IGF-1 <ULN overall by GH level at screening
    End point description
    Proportion of participants achieving IGF-1 <ULN at weeks 12, 24 & 36.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24 & 36
    End point values
    		 Pasireotide LAR overall GH: ≥ 1 - ≤ 2.5 μg/L at screening GH: > 2.5 μg/L at screening GH: Missing
    Number of subjects analysed
    123
    28
    94
    1
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 12
    20.3 (13.61 to 28.52)
    35.7 (18.64 to 55.93)
    16.0 (9.22 to 24.95)
    0.0 (0.00 to 97.50)
        Week 24
    27.6 (19.96 to 36.43)
    42.9 (24.46 to 62.82)
    23.4 (15.29 to 33.26)
    0.0 (0.00 to 97.50)
        Week 36
    30.9 (22.88 to 39.86)
    50.0 (30.65 to 69.35)
    25.5 (17.09 to 35.57)
    0.0 (0.00 to 97.50)
    No statistical analyses for this end point

    Secondary: Core phase: Proportion of participants with mean GH <1 μg/L and IGF-1 <ULN overall by baseline diabetic status

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    End point title
    		 Core phase: Proportion of participants with mean GH <1 μg/L and IGF-1 <ULN overall by baseline diabetic status
    End point description
    Core phase - Proportion of patients achieving GH <1μg/L at week 12, 24, 36 overall and by GH level at screening.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24 & 36
    End point values
    		 Diabetic Pre-diabetic Non-diabetic
    Number of subjects analysed
    52
    60
    11
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 12
    13.5 (5.59 to 25.79)
    10.0 (3.76 to 20.51)
    0.0 (0.00 to 28.49)
        Week 24
    13.5 (5.59 to 25.79)
    13.3 (5.94 to 24.59)
    9.1 (0.23 to 41.28)
        Week 36
    15.4 (6.88 to 28.08)
    16.7 (8.29 to 28.52)
    0.0 (0.00 to 28.49)
    No statistical analyses for this end point

    Secondary: Core phase: Change from baseline in scores as measured by Acromegaly Quality of Life (AcroQoL)

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    End point title
    		 Core phase: Change from baseline in scores as measured by Acromegaly Quality of Life (AcroQoL)
    End point description
    Evaluation of effect of pasireotide LAR on Health Related Quality of Life (HRQoL) was assessed using AcroQoL, an acromegaly-specific quality of life instrument. The AcroQol instrument is comprised of 22 questions divided into two scales: one evaluating physical aspects (8 items) and the other that addresses psychological aspects (14 items). The psychological scale can also be further divided into subscale that evaluates physical appearance and the other subscale focused on the impact of the disease on personal relationships of the patient (7 items each). Each of the questions has a 5-item Likert scale. The instrument was developed with input from both physicians and patients to assess those dimensions of health-related quality of life most relevant and bothersome to patients with this disease.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24 & 36
    End point values
    		 Pasireotide LAR overall - AcroQOL total scores Pasireotide LAR overall - AcroQOL physical sub-scores Pasireotide LAR overall - AcroQOL psychological sub-scores Pasireotide LAR overall - AcroQOL psycho/appearance sub-scores Pasireotide LAR overall-AcroQOL psycho/pers relatns sub-scores
    Number of subjects analysed
    123
    123
    123
    123
    123
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=120, 120, 120, 120, 118)
    4.5 ( 9.52 )
    5.3 ( 12.93 )
    4.1 ( 10.05 )
    6.5 ( 12.43 )
    1.9 ( 12.04 )
        Week 24 (n=118, 118, 118, 118, 117)
    4.7 ( 9.88 )
    5.8 ( 12.26 )
    4.0 ( 10.72 )
    7.2 ( 14.44 )
    0.9 ( 10.70 )
        Week 36 (n=110, 110, 109, 110, 108)
    4.6 ( 10.14 )
    5.4 ( 13.00 )
    4.3 ( 11.02 )
    7.0 ( 15.33 )
    1.8 ( 10.69 )
    No statistical analyses for this end point

    Secondary: Core phase: Percentage of participants reporting levels 1 - 5 by dimensions of acromegaly symptoms

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    End point title
    		 Core phase: Percentage of participants reporting levels 1 - 5 by dimensions of acromegaly symptoms
    End point description
    Symptoms of acromegaly were collected at various visits. Ring size was measured with a gauge using the fourth digit of the non-dominant hand. In the case a patient had a fourth digit size exceeding the highest size; the fifth digit of that hand was used for initial and follow-up investigation. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators also asked the participants to score the following symptoms of acromegaly: headache, fatigue, perspiration, paresthesias, osteoarthralgia according to a five-point score scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe).
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24 & 36
    End point values
    		 Pasireotide LAR overall - Acromegaly symptom: Headache Pasireotide LAR overall - Acromegaly symptom: Fatigue Pasireotide LAR overall - Acromegaly symptom: Perspiration Pasireotide LAR overall - Acromegaly symptom: Osteoarthralgia Pasireotide LAR overall - Acromegaly symptom: Paresthesiae
    Number of subjects analysed
    123
    123
    123
    123
    123
    Units: Percentage of participants
    number (not applicable)
        Week 12: Non/absent (n=119, 119, 119, 119, 119)
    56.9
    37.4
    56.9
    43.1
    69.1
        Week 12: Mild (n=119, 119, 119, 119, 119)
    24.4
    26.8
    26.8
    27.6
    15.4
        Week 12: Moderate (n=119, 119, 119, 119, 119)
    14.6
    18.7
    8.1
    14.6
    5.7
        Week 12: Severe (n=119, 119, 119, 119, 119)
    0.8
    8.9
    3.3
    8.9
    4.9
        Week 12: Very severe (n=119, 119, 119, 119, 119)
    0.0
    4.9
    1.6
    2.4
    1.6
        Week 12: Not done (n=119, 119, 119, 119, 119)
    0.0
    0.0
    0.0
    0.0
    0.0
        Week 24: Non/absent (n=119, 119, 119, 119, 119)
    59.3
    46.3
    64.2
    47.2
    72.4
        Week 24: Mild (n=119, 119, 119, 119, 119)
    27.6
    20.3
    21.1
    26.8
    13.8
        Week 24: Moderate (n=119, 119, 119, 119, 119)
    8.1
    17.9
    8.9
    14.6
    7.3
        Week 24: Severe (n=119, 119, 119, 119, 119)
    1.6
    7.3
    1.6
    3.3
    0.8
        Week 24: Very severe (n=119, 119, 119, 119, 119)
    0.0
    4.9
    0.8
    4.9
    2.4
        Week 24: Not done (n=119, 119, 119, 119, 119)
    0.0
    0.0
    0.0
    0.0
    0.0
        Week 36: Non/absent (n=113, 113, 113, 113, 113)
    63.4
    47.2
    61.8
    47.2
    69.1
        Week 36: Mild (n=113, 113, 113, 113, 113)
    17.1
    23.6
    18.7
    26.8
    14.6
        Week 36: Moderate (n=113, 113, 113, 113, 113)
    9.8
    13.0
    7.3
    12.2
    5.7
        Week 36: Severe (n=113, 113, 113, 113, 113)
    1.6
    4.9
    4.1
    3.3
    1.6
        Week 36: Very severe (n=113, 113, 113, 113, 113)
    0.0
    3.3
    0.0
    2.4
    0.8
        Week 36: Not done (n=113, 113, 113, 113, 113)
    0.0
    0.0
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Core phase: Percentage of participants with Acromegaly shift symptoms from baseline to most extreme post-baseline

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    End point title
    		 Core phase: Percentage of participants with Acromegaly shift symptoms from baseline to most extreme post-baseline
    End point description
    Symptoms of acromegaly were collected at various visits. Ring size was measured with a gauge using the fourth digit of the non-dominant hand. In the case a patient had a fourth digit size exceeding the highest size; the fifth digit of that hand was used for initial and follow-up investigation. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators also asked the participants to score the following symptoms of acromegaly: headache, fatigue, perspiration, paresthesias, osteoarthralgia according to a five-point score scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe).
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24 & 36
    End point values
    		 Pasireotide LAR overall - Acromegaly symptom: Headache Pasireotide LAR overall - Acromegaly symptom: Fatigue Pasireotide LAR overall - Acromegaly symptom: Perspiration Pasireotide LAR overall - Acromegaly symptom: Osteoarthralgia Pasireotide LAR overall - Acromegaly symptom: Paresthsiae
    Number of subjects analysed
    123
    123
    123
    123
    123
    Units: Percentage of participants
    number (not applicable)
        Baseline (BL): Non/absent
    41.5
    36.6
    43.1
    33.3
    54.5
        BL: Mild
    25.2
    17.8
    25.2
    21.1
    25.2
        BL: Moderate
    18.7
    26.0
    18.7
    26.0
    10.6
        BL: Severe
    8.9
    13.8
    8.9
    16.3
    8.9
        BL: Very severe
    5.7
    4.9
    4.1
    3.3
    0.8
        BL: Not done
    0.0
    0.0
    0.0
    0.0
    0.0
        BL: Total
    100.0
    100.0
    100.0
    100.0
    100.0
        Most extreme post-BL: total Non/absent
    36.6
    26.0
    37.4
    26.8
    47.2
        Most extreme post-BL: total Mild
    30.9
    22.8
    29.3
    26.0
    27.6
        Most extreme post-BL: total Moderate
    20.3
    22.8
    20.3
    24.4
    13.0
        Most extreme post-BL: total Severe
    9.8
    15.4
    7.3
    14.6
    9.8
        Most extreme post-BL: total Very severe
    2.4
    13.0
    5.7
    8.1
    2.4
        Most extreme post-BL: total Not done
    0.0
    0.0
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Core phase: Change from baseline in EQ-5D-5L index scores

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    End point title
    		 Core phase: Change from baseline in EQ-5D-5L index scores
    End point description
    Evaluation of effect of pasireotide LAR on health status, measured by EQ-5D-5L, a valid and reliable instrument for measuring general health status. The EQ-5D-5L consists of 2 pages – the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent’s self-rated health on a 20-cm vertical, visual analogue scale with endpoints labeled ‘the best health you can imagine’ and ‘the worst health you can imagine’.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24 & 36
    End point values
    		 Pasireotide LAR overall
    Number of subjects analysed
    123
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Week 12 (n= 119)
    0.0 ( 0.15 )
        Week 24 (n = 118)
    0.0 ( 0.15 )
        Week 36 (n = 111)
    0.0 ( 0.15 )
    No statistical analyses for this end point

    Secondary: Core phase: Change from baseline in EQ-5D-5L VAS assessment

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    End point title
    		 Core phase: Change from baseline in EQ-5D-5L VAS assessment
    End point description
    Evaluation of effect of pasireotide LAR on health status, measured by EQ-5D-5L, a valid and reliable instrument for measuring general health status. The EQ-5D-5L consists of 2 pages – the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent’s self-rated health on a 20-cm vertical, visual analogue scale with endpoints labeled ‘the best health you can imagine’ and ‘the worst health you can imagine’.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24 & 36
    End point values
    		 Pasireotide LAR overall
    Number of subjects analysed
    123
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Week 12 (n= 119)
    4.1 ( 14.91 )
        Week 24 (n = 118)
    3.4 ( 13.49 )
        Week 36 (n = 111)
    4.9 ( 15.24 )
    No statistical analyses for this end point

    Secondary: Extension phase: Proportion of participants with mean GH < 1 μg/L and IGF-1 < ULN at Weeks 48, 60 & 72

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    End point title
    		 Extension phase: Proportion of participants with mean GH < 1 μg/L and IGF-1 < ULN at Weeks 48, 60 & 72
    End point description
    Proportion of patients achieving IGF-1 <ULN at weeks 48, 60 & 72 for participants with up-titrated to Pasireotide LAR 60 mg mg
    End point type
    Secondary
    End point timeframe
    Weeks 48, 60 & 72
    End point values
    		 Up-titrated to Pasireotide LAR 60 mg
    Number of subjects analysed
    70
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 48
    5.8 (1.60 to 14.18)
        Week 60
    7.1 (2.36 to 15.89)
        Week 72
    5.7 (1.58 to 13.99)
    No statistical analyses for this end point

    Secondary: Extension phase: Proportion of participants with mean GH < 1 μg/L and IGF-1 < ULN at Weeks 48, 60 and 72

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    End point title
    		 Extension phase: Proportion of participants with mean GH < 1 μg/L and IGF-1 < ULN at Weeks 48, 60 and 72
    End point description
    Proportion of participants achieving IGF-1 <ULN at week 46, 60 and 72 overall by baseline diabetic status
    End point type
    Secondary
    End point timeframe
    Weeks 48, 60, 72
    End point values
    		 Pasireotide LAR overall
    Number of subjects analysed
    88
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 48: Diabetic
    11.6 (3.89 to 25.08)
        Week 60: Diabetic
    11.6 (3.89 to 25.08)
        Week 72: Diabetic
    11.6 (3.89 to 25.08)
        Week 48: Pre-diabetic
    11.1 (3.11 to 26.06)
        Week 60: Pre-diabetic
    16.7 (6.37 to 32.81)
        Week 72: Pre-diabetic
    8.3 (1.75 to 22.47)
        Week 48: Non-diabetic
    22.2 (2.81 to 60.01)
        Week 60: Non-diabetic
    22.2 (2.81 to 60.01)
        Week 72: Non-diabetic
    22.2 (2.81 to 60.01)
    No statistical analyses for this end point

    Secondary: Extension phase: Proportion of participants with mean GH < 1 μg/L at Weeks 48, 60 and 72, overall, Pasireotide montherapy and Pasireotide with concomittant medication and by GH level at screening

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    End point title
    		 Extension phase: Proportion of participants with mean GH < 1 μg/L at Weeks 48, 60 and 72, overall, Pasireotide montherapy and Pasireotide with concomittant medication and by GH level at screening
    End point description
    Proportion of patients achieving GH <1 μg/L and IGF-1 <ULN at week 48 by treatment with pasireotide LAR alone or with concomitant medications used to treat acromegaly
    End point type
    Secondary
    End point timeframe
    Weeks 48, 60, 72
    End point values
    		 Pasireotide LAR monotherapy Pasireotide LAR overall Pasireotide with concomitant mediaction
    Number of subjects analysed
    76
    88
    12
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 48: GH: >= 1 - <= 2.5 μg/L at screening
    76.5 (50.10 to 93.19)
    65.0 (40.78 to 84.61)
    0.0 (0.00 to 70.76)
        Week 60: GH: >= 1 - <= 2.5 μg/L at screening
    70.6 (44.04 to 89.69)
    60.0 (36.05 to 80.88)
    0.0 (0.00 to 70.76)
        Week 72: GH: >= 1 - <= 2.5 μg/L at screening
    64.7 (38.33 to 85.79)
    55.0 (31.53 to 76.94)
    0.0 (0.00 to 70.76)
        Week 48: GH: > 2.5 μg/L at screening
    11.9 (4.91 to 22.93)
    11.8 (5.22 to 21.87)
    11.1 (0.28 to 48.25)
        Week 60: GH: > 2.5 μg/L at screening
    11.9 (4.91 to 22.93)
    10.3 (4.24 to 20.07)
    0.0 (0.00 to 33.63)
        Week 72: GH: > 2.5 μg/L at screening
    11.9 (4.91 to 22.93)
    10.3 (4.24 to 20.07)
    0.0 (0.00 to 33.63)
        Week 48: Pasireotide LAR overall
    26.3 (16.87 to 37.68)
    23.9 (15.42 to 34.14)
    8.3 (0.21 to 38.48)
        Week 60: Pasireotide LAR overall
    25.0 (15.77 to 36.26)
    21.6 (13.53 to 31.65)
    0.0 (0.00 to 26.46)
        Week 72: Pasireotide LAR overall
    23.7 (14.68 to 34.82)
    20.5 (12.60 to 30.39)
    0.0 (0.00 to 26.46)
    No statistical analyses for this end point

    Secondary: Extension phase: Change from baseline in scores as measured by Acromegaly Quality of Life (AcroQoL)

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    End point title
    		 Extension phase: Change from baseline in scores as measured by Acromegaly Quality of Life (AcroQoL)
    End point description
    Evaluation of effect of pasireotide LAR on Health Related Quality of Life (HRQoL) was assessed using AcroQoL, an acromegaly-specific quality of life instrument. The AcroQol instrument is comprised of 22 questions divided into two scales: one evaluating physical aspects (8 items) and the other that addresses psychological aspects (14 items). The psychological scale can also be further divided into subscale that evaluates physical appearance and the other subscale focused on the impact of the disease on personal relationships of the patient (7 items each). Each of the questions has a 5-item Likert scale. The instrument was developed with input from both physicians and patients to assess those dimensions of health-related quality of life most relevant and bothersome to patients with this disease.
    End point type
    Secondary
    End point timeframe
    Weeks 48, 60 & 72
    End point values
    		 Pasireotide LAR overall - AcroQOL total scores Pasireotide LAR overall - AcroQOL physical sub-scores Pasireotide LAR overall - AcroQOL psychological sub-scores Pasireotide LAR overall - AcroQOL psycho/appearance sub-scores Pasireotide LAR overall-AcroQOL psycho/pers relatns sub-scores
    Number of subjects analysed
    88
    88
    88
    88
    88
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Week 60 (n = 1, 1, 1, 1, 1)
    -4.5 ( 0.0 )
    0.0 ( 0.00 )
    -7.1 ( 0.00 )
    -3.6 ( 0.00 )
    -10.7 ( 0.00 )
        Week 72 (n = 74, 74, 73, 74, 72)
    1.6 ( 9.72 )
    0.9 ( 10.61 )
    1.8 ( 10.60 )
    0.8 ( 12.82 )
    2.9 ( 11.82 )
    No statistical analyses for this end point

    Secondary: Extension phase: Percentage of participants reporting levels 1 - 5 by dimensions of acromegaly symptoms

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    End point title
    		 Extension phase: Percentage of participants reporting levels 1 - 5 by dimensions of acromegaly symptoms
    End point description
    Symptoms of acromegaly were collected at various visits. Ring size was measured with a gauge using the fourth digit of the non-dominant hand. In the case a patient had a fourth digit size exceeding the highest size; the fifth digit of that hand was used for initial and follow-up investigation. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators also asked the participants to score the following symptoms of acromegaly: headache, fatigue, perspiration, paresthesias, osteoarthralgia according to a five-point score scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe).
    End point type
    Secondary
    End point timeframe
    Weeks 48, 60 & 72
    End point values
    		 Pasireotide LAR overall - Acromegaly symptom: Headache Pasireotide LAR overall - Acromegaly symptom: Fatigue Pasireotide LAR overall - Acromegaly symptom: Perspiration Pasireotide LAR overall - Acromegaly symptom: Osteoarthralgia Pasireotide LAR overall - Acromegaly symptom: Paresthesiae
    Number of subjects analysed
    88
    88
    88
    88
    88
    Units: Percentage of participants
    number (not applicable)
        Week 48: None/absent (n= 81, 81, 81, 81, 81)
    63.6
    59.1
    69.3
    53.4
    71.6
        Week 48: Mild (n= 81, 81, 81, 81, 81)
    19.3
    17.0
    13.6
    25.0
    14.8
        Week 48: Moderate (n= 81, 81, 81, 81, 81)
    8.0
    12.5
    9.1
    9.1
    4.5
        Week 48: Severe (n= 81, 81, 81, 81, 81)
    1.1
    3.4
    0.0
    3.4
    0.0
        Week 48: Very severe (n= 81, 81, 81, 81, 81)
    0.0
    0.0
    0.0
    1.1
    1.1
        Week 48: Not done (n= 81, 81, 81, 81, 81)
    0.0
    0.0
    0.0
    0.0
    0.0
        Week 60: None/absent (n = 77, 77, 77, 77, 77)
    60.2
    48.9
    60.2
    56.8
    70.5
        Week 60: Mild (n = 77, 77, 77, 77, 77)
    17.0
    20.5
    20.5
    14.8
    10.2
        Week 60: Moderate (n = 77, 77, 77, 77, 77)
    6.8
    13.6
    6.8
    11.4
    4.5
        Week 60: Severe (n = 77, 77, 77, 77, 77)
    3.4
    4.5
    0.0
    3.4
    1.1
        Week 60: Very severe (n = 77, 77, 77, 77, 77)
    0.0
    0.0
    0.0
    1.1
    1.1
        Week 60: Not done (n = 77, 77, 77, 77, 77)
    0.0
    0.0
    0.0
    0.0
    0.0
        Week 72: None/absent (n = 74, 74, 74, 74, 74)
    56.8
    44.3
    61.4
    51.1
    67.0
        Week 72: Mild (n = 74, 74, 74, 74, 74)
    17.0
    23.9
    15.9
    20.5
    11.4
        Week 72: Moderate (n = 74, 74, 74, 74, 74)
    8.0
    10.2
    6.8
    10.2
    5.7
        Week 72: Severe (n = 74, 74, 74, 74, 74)
    2.3
    4.5
    0.0
    1.1
    0.0
        Week 72: Very severe (n = 74, 74, 74, 74, 74)
    0.0
    1.1
    0.0
    1.1
    0.0
        Week 72: Not done (n = 74, 74, 74, 74, 74)
    0.0
    0.0
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Extension phase: Percentage of participants with Acromegaly shift symptoms from extension baseline to most extreme post-extension baseline

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    End point title
    		 Extension phase: Percentage of participants with Acromegaly shift symptoms from extension baseline to most extreme post-extension baseline
    End point description
    Symptoms of acromegaly were collected at various visits. Ring size was measured with a gauge using the fourth digit of the non-dominant hand. In the case a patient had a fourth digit size exceeding the highest size; the fifth digit of that hand was used for initial and follow-up investigation. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators also asked the participants to score the following symptoms of acromegaly: headache, fatigue, perspiration, paresthesias, osteoarthralgia according to a five-point score scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe).
    End point type
    Secondary
    End point timeframe
    Weeks 48, 60 & 72
    End point values
    		 Pasireotide LAR overall - Acromegaly symptom: Headache Pasireotide LAR overall - Acromegaly symptom: Fatigue Pasireotide LAR overall - Acromegaly symptom: Perspiration Pasireotide LAR overall - Acromegaly symptom: Osteoarthralgia Pasireotide LAR overall - Acromegaly symptom: Paresthsiae
    Number of subjects analysed
    88
    88
    88
    88
    88
    Units: Percentage of participants
    number (not applicable)
        Extension (Ext.)Baseline (BL): Non/absent
    69.3
    56.8
    68.2
    52.3
    79.5
        Ext. BL: Mild
    20.5
    23.9
    20.5
    30.7
    13.6
        Ext. BL: Moderate
    9.1
    12.5
    10.2
    12.5
    5.7
        Ext. BL: Severe
    1.1
    4.5
    1.1
    3.4
    0.0
        Ext. BL: Very severe
    0.0
    2.3
    0.0
    1.1
    1.1
        Ext. BL: Not done
    0.0
    0.0
    0.0
    0.0
    0.0
        Ext. BL: Total
    100.0
    100.0
    100.0
    100.0
    100.0
        Most extreme post-BL: total Non/absent
    46.6
    51.1
    54.5
    43.2
    67.0
        Most extreme post-BL: total Mild
    29.5
    22.7
    26.1
    33.0
    22.7
        Most extreme post-BL: total Moderate
    18.2
    18.2
    14.8
    13.6
    6.8
        Most extreme post-BL: total Severe
    3.4
    6.8
    4.5
    8.0
    2.3
        Most extreme post-BL: total Very severe
    2.3
    1.1
    0.0
    2.3
    1.1
        Most extreme post-BL: total Not done
    0.0
    0.0
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Extension phase: Change from baseline in EQ-5D-5L index scores

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    End point title
    		 Extension phase: Change from baseline in EQ-5D-5L index scores
    End point description
    Evaluation of effect of pasireotide LAR on health status, measured by EQ-5D-5L, a valid and reliable instrument for measuring general health status. The EQ-5D-5L consists of 2 pages – the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent’s self-rated health on a 20-cm vertical, visual analogue scale with endpoints labeled ‘the best health you can imagine’ and ‘the worst health you can imagine’.
    End point type
    Secondary
    End point timeframe
    Weeks 48, 60 & 72
    End point values
    		 Pasireotide LAR overall
    Number of subjects analysed
    88
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Week 60 (n = 1)
    -0.1 ( 0.00 )
        Week 72 (n = 73)
    0.0 ( 0.08 )
    No statistical analyses for this end point

    Secondary: Extension phase: Change from baseline in EQ-5D-5L VAS assessment

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    End point title
    		 Extension phase: Change from baseline in EQ-5D-5L VAS assessment
    End point description
    Evaluation of effect of pasireotide LAR on health status, measured by EQ-5D-5L, a valid and reliable instrument for measuring general health status. The EQ-5D-5L consists of 2 pages – the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent’s self-rated health on a 20-cm vertical, visual analogue scale with endpoints labeled ‘the best health you can imagine’ and ‘the worst health you can imagine’.
    End point type
    Secondary
    End point timeframe
    Weeks 48, 60 & 72
    End point values
    		 Pasireotide LAR overall
    Number of subjects analysed
    88
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Week 60 (n = 1)
    -10.0 ( 0.0 )
        Week 72 (n = 73)
    1.6 ( 9.14 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 84 days post treatment, up to maximum duration of 76 weeks.
    Adverse event reporting additional description
    AE is any sign or symptom that occurs during the study treatment plus the 84 days post treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Pasireotide LAR overall
    Reporting group description
    		 Pasireotide LAR overall

    Reporting group title
    Up-titrated to Pasireotide LAR 60 mg
    Reporting group description
    		 Up-titrated to Pasireotide LAR 60 mg

    Serious adverse events
    		 Pasireotide LAR overall Up-titrated to Pasireotide LAR 60 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 123 (9.76%)
    6 / 92 (6.52%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 123 (0.81%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatofibrosarcoma protuberans
         subjects affected / exposed
    1 / 123 (0.81%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Stress cardiomyopathy
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 123 (0.81%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 123 (0.81%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    1 / 123 (0.81%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary dilatation
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    2 / 123 (1.63%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    2 / 123 (1.63%)
    2 / 92 (2.17%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Nose deformity
         subjects affected / exposed
    1 / 123 (0.81%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Tonsillitis
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ketoacidosis
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pasireotide LAR overall Up-titrated to Pasireotide LAR 60 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    112 / 123 (91.06%)
    83 / 92 (90.22%)
    Investigations
    Blood glucose increased
         subjects affected / exposed
    8 / 123 (6.50%)
    7 / 92 (7.61%)
         occurrences all number
    11
    10
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    9 / 123 (7.32%)
    8 / 92 (8.70%)
         occurrences all number
    21
    19
    Nervous system disorders
    Headache
         subjects affected / exposed
    14 / 123 (11.38%)
    11 / 92 (11.96%)
         occurrences all number
    19
    15
    Paraesthesia
         subjects affected / exposed
    6 / 123 (4.88%)
    6 / 92 (6.52%)
         occurrences all number
    6
    6
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    13 / 123 (10.57%)
    11 / 92 (11.96%)
         occurrences all number
    13
    11
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    7 / 123 (5.69%)
    4 / 92 (4.35%)
         occurrences all number
    12
    9
    Fatigue
         subjects affected / exposed
    8 / 123 (6.50%)
    4 / 92 (4.35%)
         occurrences all number
    8
    4
    Injection site pain
         subjects affected / exposed
    4 / 123 (3.25%)
    2 / 92 (2.17%)
         occurrences all number
    4
    2
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    6 / 123 (4.88%)
    6 / 92 (6.52%)
         occurrences all number
    6
    6
    Abdominal pain
         subjects affected / exposed
    12 / 123 (9.76%)
    10 / 92 (10.87%)
         occurrences all number
    22
    19
    Diarrhoea
         subjects affected / exposed
    22 / 123 (17.89%)
    16 / 92 (17.39%)
         occurrences all number
    35
    28
    Nausea
         subjects affected / exposed
    7 / 123 (5.69%)
    5 / 92 (5.43%)
         occurrences all number
    8
    5
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    10 / 123 (8.13%)
    8 / 92 (8.70%)
         occurrences all number
    12
    10
    Hepatic steatosis
         subjects affected / exposed
    7 / 123 (5.69%)
    7 / 92 (7.61%)
         occurrences all number
    7
    7
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    11 / 123 (8.94%)
    8 / 92 (8.70%)
         occurrences all number
    11
    8
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 123 (5.69%)
    6 / 92 (6.52%)
         occurrences all number
    8
    7
    Back pain
         subjects affected / exposed
    6 / 123 (4.88%)
    4 / 92 (4.35%)
         occurrences all number
    6
    4
    Muscle spasms
         subjects affected / exposed
    6 / 123 (4.88%)
    5 / 92 (5.43%)
         occurrences all number
    7
    6
    Osteoarthritis
         subjects affected / exposed
    2 / 123 (1.63%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    Pain in extremity
         subjects affected / exposed
    8 / 123 (6.50%)
    8 / 92 (8.70%)
         occurrences all number
    11
    11
    Tendonitis
         subjects affected / exposed
    4 / 123 (3.25%)
    2 / 92 (2.17%)
         occurrences all number
    4
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    5 / 123 (4.07%)
    3 / 92 (3.26%)
         occurrences all number
    6
    3
    Cystitis
         subjects affected / exposed
    2 / 123 (1.63%)
    0 / 92 (0.00%)
         occurrences all number
    5
    0
    Influenza
         subjects affected / exposed
    11 / 123 (8.94%)
    7 / 92 (7.61%)
         occurrences all number
    13
    8
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 123 (6.50%)
    7 / 92 (7.61%)
         occurrences all number
    16
    15
    Viral upper respiratory tract infection
         subjects affected / exposed
    11 / 123 (8.94%)
    7 / 92 (7.61%)
         occurrences all number
    14
    7
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    29 / 123 (23.58%)
    22 / 92 (23.91%)
         occurrences all number
    35
    27
    Hyperglycaemia
         subjects affected / exposed
    56 / 123 (45.53%)
    39 / 92 (42.39%)
         occurrences all number
    76
    52
    Hypoglycaemia
         subjects affected / exposed
    13 / 123 (10.57%)
    10 / 92 (10.87%)
         occurrences all number
    24
    17
    Impaired fasting glucose
         subjects affected / exposed
    7 / 123 (5.69%)
    7 / 92 (7.61%)
         occurrences all number
    9
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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