Pasireotide in Patients With Acromegaly Inadequately Cont... | NCT02354508

ID	Type	Description	Link
2014-002630-31	EudraCT Number

Pasireotide in Patients With Acromegaly Inadequately Cont... | NCT02354508 | Trialant

Description Module

Detailed Description

This is a phase IIIb multicenter, open-label; single arm study to evaluate the efficacy and safety of pasireotide LAR 40 mg and 60 mg in patients with inadequately controlled acromegaly with maximal doses of first generation somatostatin analogues. The study will enroll inadequately controlled patients by high doses of first-generation somatostatin analogues given for at least 3 months.

Patients will be categorized into two groups. Group 1 consists of patients treated with octreotide LAR 30 mg from countries where octreotide LAR 40mg is approved for the treatment of acromegaly at the time of screening. These patients will start a 3-months run-in phase to receive 40mg octreotide before being considered eligible to enter the core treatment phase. After 3 months of treatment have been completed, and prior to the fourth injection a mean GH and IGF-1 will be assessed. Patients who are achieving biochemical control will be considered a screen failure and they will not qualify for the core phase of the study. They will continue treatment with octreotide LAR 40 mg outside the frame of this study.

Group 2 consists of patients treated with octreotide LAR 30 mg from countries where octreotide 40mg is NOT yet approved at the time of screening. This group also includes patients already treated with octreotide LAR 40 mg or lanreotide ATG 120 mg. Patients should have been treated with the first generation SSAs for at least 3 months prior to screening. Eligible patients can directly enter the core treatment phase of the study. A run-in phase is not required for this patient population.

In the core treatment phase patients will start treatment with pasireotide LAR 40 mg every 4 weeks. At week 12, the mean GH value and IGF-1value will be assessed. Patients who have not achieved biochemical control by week 12 and do not have any tolerability issues with pasireotide LAR 40 mg will have the dose increased to 60 mg. Patients who have achieved biochemical control by week 12 will maintain a dose of pasireotide LAR 40 mg. A mean GH value and IGF-1 value will be assessed every 12 weeks until Visit 777. At weeks 16 and 28, the investigator will be able to adjust the dose based on the achievement of biochemical control and drug tolerability. If tolerability issues occur, the dose can be decreased in 20 mg. Once the tolerability issue resolves, the patients should return to the dose previously received. Patients will be treated for a total of 36 weeks during the core phase. During this period any concomitant medication for the treatment of acromegaly is prohibited. Patients are required to complete a core phase completion visit 4 weeks after the last dose of pasireotide LAR is administered. Patients who discontinue from the core phase are also required to complete the core phase completion visit 4 weeks after receiving the last pasireotide LAR dose.

Patients who have completed all visits of core phase and have completed all the assessments at the core phase completion visit (Visit 777) can move into the extension phase. The core phase completion visit performed at Visit 777, will also be the first visit (Visit 18) of the extension phase. At Visit 18, the patients will receive the same dose of pasireotide LAR that they received at week 32 (Visit 17). At week 40 (Visit 19), the investigator will decide the treatment regimen and the pasireotide LAR dose based on the achievement of biochemical control at Visit 777. Patients achieving biochemical control at the end of the core phase will continue pasireotide LAR monotherapy at the same dose of the core phase. Patients who are uncontrolled at the end of the core phase will continue pasireotide LAR 60 mg and they will be allowed to receive concomitant treatment with medications used to treat acromegaly based on the investigator's clinical judgment. GH and IGF-1 levels will be assessed every 12 weeks until week 72. At weeks 52 and 64, the investigator will be able to adjust the dose of pasireotide LAR and the regimen of the concomitant medication used to acromegaly based on the patients achievement of biochemical control and drug tolerability. Patients will be treated for a total of 32 weeks in the extension phase and receive the last dose of study treatment at week 68 (Visit 26). Patients are required to complete an extension phase completion visit (Visit 778) 4 weeks after the last dose of pasireotide LAR is administered. Patients who prematurely discontinue from the extension phase are also required to complete the extension phase completion visit (Visit 778) 4 weeks after receiving the last dose of pasireotide LAR.

After discontinuation from the study or completion of study treatment either at the core phase or extension phase of the study, all patients will be followed for safety for 12 weeks (84 days) after the last study drug administration. This visit can be performed by phone, a study visit for follow-up is not mandatory.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pasireotide LAR	Experimental	Patients who qualify for the core phase of the study will be treated with pasireotide LAR 40 mg initially. Patients not achieving biochemical control can be up-titrated to pasireotide LAR 60 mg.	Drug: Pasireotide LAR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pasireotide LAR	Drug	Pasireotide 40 mg and 60 mg. Pasireotide 20 mg which was allowed for dose decrease in case of adverse event.	Pasireotide LAR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall	Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 \	Week 36
Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 for Participants Up-titrated to Pasireotide LAR 60 mg	Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 \	Week 36
Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36	Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 \	Wek 36
Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36	Percentage of patients who achieved biochemical control defined as GH <1μg/L and IGF-1 \	Week 36
Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 Overall by Baseline Diabetic Status	Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 \	Week 36
Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall - LOCF	Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 \

Secondary Outcomes

Measure	Description	Time Frame
Core Phase: Change in Mean Growth Hormone (GH) Values From Baseline to Week 36	Core phase - Changes in mean GH from study baseline to week 36.	Baseline, week 36
Core Phase: Change in Standardized IGF-1 Values From Baseline to Week 36

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent
Male and female patients ≥18 years
Patients with confirmed diagnosis of inadequately controlled acromegaly (mean GH concentration ≥1 μg/L and sex- and age-adjusted IGF-1 >1.3 x ULN)
Patients treated with octreotide LAR (30 mg or 40 mg) or lanreotide ATG (120 mg) monotherapy for at least 3 months prior to screening

Exclusion Criteria:

Concomitant treatment with other medications reducing GH and or IGF-1, unless discontinued 3 months prior to screening
Patients with compression of the optic chiasm requiring surgical intervention
Diabetic patients with HbA1c >8% at screening
Patients who are hypothyroid and not on adequate replacement therapy
Patients with symptomatic cholelithiasis and acute or chronic pancreatitis
Patients with clinically significant valvular disease
Patients with risk factors for torsade de pointes (TdP)
Hypokalaemia, hypomagnesaemia, uncontrolled hypothyroidism, family history of long QT syndrome or concomitant medications with known risk of TdP
Patients with congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, advanced heart block, history of acute MI less than one year prior to study entry or clinically significant impairment in cardiovascular function.
Concomitant disease(s) that could prolong the QT interval such as autonomic neuropathy (caused by diabetes or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
Patients with liver disease or ALT/AST > 2.0 X ULN, serum bilirubin >2.0 X ULN - Presence of Hepatitis B surface antigen or Hepatitis C antibody test
Patients with serum creatinine >2.0 X ULN
Patients with WBC <3 X 109/L; Hb 90% < LLN; PLT <100 X 109/L
Patients with active or suspected acute or chronic uncontrolled infection
Patients who have undergone major surgery/surgical therapy within 4 weeks prior to screening
Patients with active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)
Patients with abnormal coagulation (PT and/or APTT elevated by 30% above normal limits) or patients receiving anticoagulants that affect PT (prothrombin time) or APTT (activated partial thromboplastin time)
History of syncope or family history of idiopathic sudden death
History of immunocompromise, including a positive HIV test result (ELISA and Western blot)
Known hypersensitivity to somatostatin analogues or any other component of pasireotide LAR
Patients who have a history of alcohol or drug abuse in the 6 month period prior to receiving pasireotide
Patients who have given a blood donation (of 400 ml or more) within 2 months before receiving pasireotide
Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
Patients with any current or prior medical condition interfering with the conduct of the study or the evaluation of the study results
Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study.
Sexually active males unless they use a condom during intercourse while taking drug and for 3 months following last dose of pasireotide
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and 3 months following the last dose of pasireotide.

Contacts/Locations Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		CABA	Buenos Aires	C1180AAX	Argentina
Novartis Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32117045	Derived	Gadelha M, Bex M, Colao A, Pedroza Garcia EM, Poiana C, Jimenez-Sanchez M, Yener S, Mukherjee R, Bartalotta A, Maamari R, Raverot G. Evaluation of the Efficacy and Safety of Switching to Pasireotide in Patients With Acromegaly Inadequately Controlled With First-Generation Somatostatin Analogs. Front Endocrinol (Lausanne). 2020 Feb 3;10:931. doi: 10.3389/fendo.2019.00931. eCollection 2019.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Lanreotide 120 mg	Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
FG001	Octreotide 30 mg	Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 5, 2015	Sep 26, 2019

Type	Comment	Reasons
Adverse Event		FG0001 subjects FG0011 subjects FG0022 subjects
Unsatisfactory therapeutic effect		FG0001 subjects FG0010 subjects FG0022 subjects
Withdrawal by Subject		FG0000 subjects FG0011 subjects FG0022 subjects

Period 2: Extension Phase

Type	Comment	Milestone Data
STARTED		FG00026 subjectsnot all patients who completed the Core phase went into the Extension phase FG00123 subjectsnot all patients who completed the Core phase went into the Extension phase FG00239 subjectsnot all patients who completed the Core phase went into the Extension phase
COMPLETED	Completed 72 week extension phase	FG00020 subjects FG00119 subjects FG00236 subjects
NOT COMPLETED		FG0006 subjects FG0014 subjects FG0023 subjects

Type	Comment	Reasons
Unsatisfactory therapeutic effect		FG0001 subjects FG0013 subjects FG0022 subjects
Withdrawal by Subject		FG000

Period 3: Post-treatment Follow up Phase

Type	Comment	Milestone Data
STARTED	Entered post-treatment follow up	FG00026 subjects FG00123 subjects FG00239 subjects
Entered Post-treatment f/up Discontinued		FG0004 subjectsEntered post-treatment follow-up, discontinued FG0013 subjectsEntered post-treatment follow-up, discontinued FG0023 subjectsEntered post-treatment follow-up, discontinued
COMPLETED	Entered post-treatment follow-up, completed	FG00022 subjectsEntered post-treatment follow-up, completed FG00120 subjectsEntered post-treatment follow-up, completed FG00236 subjectsEntered post-treatment follow-up, completed
NOT COMPLETED		FG0004 subjects FG0013 subjects FG0023 subjects

Type	Comment	Reasons
Unsatisfactory therapeutic effect		FG0001 subjects FG0012 subjects FG0022 subjects
Withdrawal by Subject		FG000

Arm/Group Information

ID	Title	Description
BG000	Lanreotide 120 mg	Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
BG001	Octreotide 30 mg	Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .
BG002	Octreotide 40 mg	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).
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00041.8± 10.02 BG00141.6± 12.89 BG00246.6± 11.63 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00019 BG00118 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

Caucasian

Title	Measurements
	BG00034 BG00114 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall

Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 \

Full Analysis Set (FAS) comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.

Posted

Number

95% Confidence Interval

Percentage of participants

Week 36

ID	Title	Description
OG000	Lanreotide 120 mg	Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
OG001	Octreotide 30 mg	Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .
OG002	Octreotide 40 mg	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).
OG003	Pasireotide LAR Overall	This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

Units	Counts
Participants	OG00041 OG00129 OG00253 OG003

Title

Denominators

Categories

Title	Measurements
	OG00014.6(5.57 to 29.17) OG00113.8(3.89 to 31.66) OG00215.1(6.75 to 27.59) OG003

Primary

Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 for Participants Up-titrated to Pasireotide LAR 60 mg

Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 \

Full Analysis Set (FAS) comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study. For these patients the Pasireotide LAR dose was uptitrated to 60 mg before Week 36.

Posted

Number

95% Confidence Interval

Percentage of participants

Week 36

ID	Title	Description
OG000	Up-titrated to Pasireotide LAR 60 mg	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.

Units	Counts
Participants	OG000

Primary

Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36

Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 \

Per-Protocol Set (PPS): consisted of a subset of the patients in the FAS who were compliant with requirements of the clinical study protocol. The protocol deviations criteria were defined prior to database lock. Per-protocol analysis was performed during the core phase, but not during the extension phase.

Posted

Number

95% Confidence Interval

Percentage of participants

Wek 36

ID	Title	Description
OG000	Pasireotide LAR Overall	This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

Units	Counts
Participants	OG000

Primary

Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36

Percentage of patients who achieved biochemical control defined as GH <1μg/L and IGF-1 \

Full Analysis Set (FAS) comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.

Posted

Number

95% Confidence Interval

Percentage of participants

Week 36

ID	Title	Description
OG000	Lanreotide 120 mg	Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
OG001	Octreotide 30 mg	Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .
OG002	Octreotide 40 mg	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).

Primary

Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 for Participants Up-titrated to Pasireotide LAR 60 mg

Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 \

Posted

Number

95% Confidence Interval

Percentage of participants

Week 36

ID	Title	Description
OG000	Up-titrated to Pasireotide LAR 60 mg	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.

Units	Counts
Participants	OG000

Primary

Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 Overall by Baseline Diabetic Status

Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 \

Full Analysis Set (FAS) comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.

Posted

Number

95% Confidence Interval

Percentage of participants

Week 36

ID	Title	Description
OG000	Pasireotide LAR Overall	This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

Units	Counts
Participants	OG000

Primary

Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall - LOCF

Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 \

Full Analysis Set (FAS) comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.

Posted

Number

95% Confidence Interval

Percentage of participants

Week 36

ID	Title	Description
OG000	Lanreotide 120 mg	Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
OG001	Octreotide 30 mg	Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .
OG002	Octreotide 40 mg	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).

Secondary

Core Phase: Change in Mean Growth Hormone (GH) Values From Baseline to Week 36

Core phase - Changes in mean GH from study baseline to week 36.

FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.

Posted

Mean

Standard Deviation

percentage change

Baseline, week 36

ID	Title	Description
OG000	Lanreotide 120 mg	Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
OG001	Octreotide 30 mg	Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .
OG002	Octreotide 40 mg	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).
OG003	Pasireotide LAR Overall

Secondary

Core Phase: Change in Standardized IGF-1 Values From Baseline to Week 36

Core phase - Changes in standardized IGF-1 from study baseline to week 36.

FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.

Posted

Mean

Standard Deviation

percentage change

Baseline, week 36

ID	Title	Description
OG000	Lanreotide 120 mg	Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
OG001	Octreotide 30 mg	Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .
OG002	Octreotide 40 mg	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).
OG003	Pasireotide LAR Overall

Secondary

Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN

Percentage of participants achieving GH <1 μg/L and IGF-1 \

FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.

Posted

Number

95% Confidence Interval

Percentage of participants

Week 12, Week 24, Week 36

ID	Title	Description
OG000	Pasireotide LAR (run-in Phase)	Participants who were part of the run-in phase, i.e. group 1)
OG001	Pasireotide LAR Overall	This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

Units	Counts
Participants	OG000

Secondary

Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening

Percentage of participants achieving IGF-1 \

FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study

Posted

Number

95% Confidence Interval

Percentage of participants

Weeks 12, 24 & 36

ID	Title	Description
OG000	GH: ≥1 - ≤ 2.5 μg/L	These Participants had this GH level at screening
OG001	GH: > 2.5 μg/L	These Participants had this GH level at screening
OG002	GH: Missing	These Participants were missing GH levels at screening
OG003	Pasireotide LAR Overall	This is the total sum of participants with at screening with various or missing GH levels

Secondary

Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN Overall by Baseline Diabetic Status

Core phase - Percentage of patients achieving GH <1μg/L at week 12, 24, 36 overall and by GH level at screening.

FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.

Posted

Number

95% Confidence Interval

Percentage of participants

Weeks 12, 24 & 36

ID	Title	Description
OG000	Diabetic	Participants who were diabetic in the Pasireotide LAR overall group
OG001	Pre-diabetic	Participants who were pre-diabetic in the Pasireotide LAR overall group
OG002	Non-diabetic	Participants who were non-diabetic in the Pasireotide LAR overall group

Units	Counts
Participants

Secondary

Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL)

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. For each dimension the scores range from 0-4 with 0 being the lowest impact and 4 being the most severe.

FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study

Posted

Mean

Standard Deviation

scores on a scale

Baseline, Weeks 12, 24 & 36

ID	Title	Description
OG000	Pasireotide LAR Overall - AcroQOL Total Scores	This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
OG001	Pasireotide LAR Overall - AcroQOL Physical Sub-scores	This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg

Secondary

Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms

Symptoms of acromegaly were collected at various visits. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators 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).

FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study

Posted

Number

Percentage of participants

Weeks 12, 24 & 36

ID	Title	Description
OG000	Pasireotide LAR Overall - Acromegaly Symptom: Headache	This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
OG001	Pasireotide LAR Overall - Acromegaly Symptom: Fatigue	This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg
OG002	Pasireotide LAR Overall - Acromegaly Symptom: Perspiration	This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

Secondary

Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline

FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study

Posted

Number

Percentage of participants

Weeks 12, 24 & 36

ID	Title	Description
OG000	Pasireotide LAR Overall - Acromegaly Symptom: Headache	This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
OG001	Pasireotide LAR Overall - Acromegaly Symptom: Fatigue	This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg
OG002	Pasireotide LAR Overall - Acromegaly Symptom: Perspiration

Secondary

Core Phase: Change From Baseline in EQ-5D-5L Index Scores

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'. This scale is numbered from 0 to 100. 100 means the best health you can imagine.

0 means the worst health you can imagine.

FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study

Posted

Mean

Standard Deviation

scores on a scale

Baseline, Weeks 12, 24 & 36

ID	Title	Description
OG000	Pasireotide LAR Overall	This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

Units	Counts
Participants

Secondary

Core Phase: Change From Baseline in EQ-5D-5L VAS Assessment

0 means the worst health you can imagine.

FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study

Posted

Mean

Standard Deviation

scores on a scale

Baseline, Weeks 12, 24 & 36

ID	Title	Description
OG000	Pasireotide LAR Overall	This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

Units	Counts
Participants

Secondary

Extension Phase: Percentage of Participants With Mean GH < 1 μg/L and IGF-1 < ULN at Weeks 48, 60 & 72 (Up-titrated to Pasireotide LAR 60 mg)

Percentage of patients achieving IGF-1 \

Extension Full Analysis Set (Extension FAS) included all the patients who received at least one dose of pasireotide LAR in the extension phase.

Posted

Number

95% Confidence Interval

Percentage of participants

Weeks 48, 60 & 72

ID	Title	Description
OG000	Up-titrated to Pasireotide LAR 60 mg	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.

Units	Counts
Participants	OG000

Secondary

Extension Phase: Percentage of Participants With Mean GH < 1 μg/L and IGF-1 < ULN at Weeks 48, 60 and 72 (Overall by Baseline Diabetic Status)

Percentage of participants achieving IGF-1 \

Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.

Posted

Number

95% Confidence Interval

Percentage of participants

Weeks 48, 60, 72

ID	Title	Description
OG000	Pasireotide LAR Overall	These are the participants in the extension phase who received Pasireotide LAR

Units	Counts
Participants	OG000

Secondary

Extension Phase: Percentage of Participants With Mean GH < 1 μg/L at Weeks 48, 60, 72 and Overall, Pasireotide Montherapy and Pasireotide With Concomittant Medication and by GH Level at Screening

Percentage of patients achieving GH <1 μg/L and IGF-1 \

Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.

Posted

Number

95% Confidence Interval

Percentage of participants

Weeks 48, 60, 72

ID	Title	Description
OG000	Pasireotide LAR Monotherapy	These Participants were treated with pasireotide LAR only in the extension phase
OG001	Pasireotide With Concomitant Mediaction	These Participants were treated with pasireotide LAR as well as other concomitant medications in the extension phase
OG002	Pasireotide LAR Overall	This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

Secondary

Extension Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL)

Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.

Posted

Mean

Standard Deviation

scores on a scale

Baseline, Weeks 48, 60 & 72

ID	Title	Description
OG000	Pasireotide LAR Overall - AcroQOL Total Scores	This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
OG001	Pasireotide LAR Overall - AcroQOL Physical Sub-scores	This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

Secondary

Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms

Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.

Posted

Number

Percentage of participants

Weeks 48, 60 & 72

ID	Title	Description
OG000	Pasireotide LAR Overall - Acromegaly Symptom: Headache	This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
OG001	Pasireotide LAR Overall - Acromegaly Symptom: Fatigue	This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
OG002	Pasireotide LAR Overall - Acromegaly Symptom: Perspiration	This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

Secondary

Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline

Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.

Posted

Number

Percentage of participants

Weeks 48, 60 & 72

ID	Title	Description
OG000	Pasireotide LAR Overall - Acromegaly Symptom: Headache	This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
OG001	Pasireotide LAR Overall - Acromegaly Symptom: Fatigue	This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
OG002	Pasireotide LAR Overall - Acromegaly Symptom: Perspiration	This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

Secondary

Extension Phase: Change From Baseline in EQ-5D-5L Index Scores

0 means the worst health you can imagine.

Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.

Posted

Mean

Standard Deviation

scores on a scale

Baseline, Weeks 48, 60 & 72

ID	Title	Description
OG000	Pasireotide LAR Overall	These are the participants in the extension phase who received Pasireotide LAR

Units	Counts
Participants

Secondary

Extension Phase: Change From Baseline in EQ-5D-5L VAS Assessment

0 means the worst health you can imagine.

Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.

Posted

Mean

Standard Deviation

scores on a scale

Baseline, Weeks 48, 60 & 72

ID	Title	Description
OG000	Pasireotide LAR Overall	These are the participants in the extension phase who received Pasireotide LAR

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Up-titrated to Pasireotide LAR 60 mg	Patients not achieving biochemical control and were up-titrated to pasireotide LAR 60 mg.	0	92	6	92	83	92
EG001	Pasireotide LAR Overall	This is the sum total of participants in under the previous treatments in the Core phase: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg or who were treated with at least one dose of pasireotide LAR in the extension phase	0	123	12	123	112	123

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected92 at risk EG0011 affected123 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected92 at risk EG0011 affected123 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected92 at risk EG0012 affected123 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected92 at risk EG0011 affected123 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected92 at risk EG0011 affected123 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected92 at risk EG0011 affected123 at risk
Biliary dilatation	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected92 at risk EG0011 affected123 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected92 at risk EG0012 affected123 at risk
Tonsillitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected92 at risk EG0011 affected123 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected92 at risk EG0011 affected123 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected92 at risk EG0011 affected123 at risk
Nose deformity	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected92 at risk EG0011 affected123 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected92 at risk EG0011 affected123 at risk
Dermatofibrosarcoma protuberans	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected92 at risk EG0011 affected123 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG00011 affected92 at risk EG00113 affected123 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0008 affected92 at risk EG0019 affected123 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0006 affected92 at risk EG0016 affected123 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG00010 affected92 at risk EG00112 affected123 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG00016 affected92 at risk EG00122 affected123 at risk
Nausea	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0005 affected92 at risk EG0017 affected123 at risk
Asthenia	General disorders	MedDRA (20.1)	Systematic Assessment	EG0004 affected92 at risk EG0017 affected123 at risk
Fatigue	General disorders	MedDRA (20.1)	Systematic Assessment	EG0004 affected92 at risk EG0018 affected123 at risk
Injection site pain	General disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected92 at risk EG0014 affected123 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0008 affected92 at risk EG00110 affected123 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0007 affected92 at risk EG0017 affected123 at risk
Bronchitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0003 affected92 at risk EG0015 affected123 at risk
Cystitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected92 at risk EG0012 affected123 at risk
Influenza	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0007 affected92 at risk EG00111 affected123 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0007 affected92 at risk EG0018 affected123 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0007 affected92 at risk EG00111 affected123 at risk
Blood glucose increased	Investigations	MedDRA (20.1)	Systematic Assessment	EG0007 affected92 at risk EG0018 affected123 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG00022 affected92 at risk EG00129 affected123 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG00039 affected92 at risk EG00156 affected123 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG00010 affected92 at risk EG00113 affected123 at risk
Impaired fasting glucose	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0007 affected92 at risk EG0017 affected123 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0006 affected92 at risk EG0017 affected123 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0004 affected92 at risk EG0016 affected123 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0005 affected92 at risk EG0016 affected123 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected92 at risk EG0012 affected123 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0008 affected92 at risk EG0018 affected123 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected92 at risk EG0014 affected123 at risk
Headache	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG00011 affected92 at risk EG00114 affected123 at risk
Paraesthesia	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0006 affected92 at risk EG0016 affected123 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0008 affected92 at risk EG00111 affected123 at risk

Ancestor Terms

ID	Term
D001849	Bone Diseases, Endocrine
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D006964	Hyperpituitarism
D010900	Pituitary Diseases
D007027	Hypothalamic Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D004700	Endocrine System Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D001848	Bone Diseases, Developmental
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D007029	Hypothalamic Neoplasms
D015173	Supratentorial Neoplasms
D001932	Brain Neoplasms
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms

Title

Denominators

Categories

Diabetic

- ParticipantsOG00043

Title	Measurements
	OG00014.0(5.30 to 27.93)

Pre-diabetic

- ParticipantsOG00036

Title	Measurements
	OG00019.4(8.19 to 36.02)

Non-diabetic

- ParticipantsOG0009

Title	Measurements
	OG0000.0(0.00 to 33.63)

Title

Denominators

Categories

Week 12: GH: ≥ 1 - ≤ 2.5 μg/L @ screening

- ParticipantsOG0004
- ParticipantsOG00128

Title	Measurements
	OG00025.0(0.63 to 80.59) OG00128.6(13.22 to 48.67)

Week 24: GH: ≥ 1 - ≤ 2.5 μg/L @ screening

- ParticipantsOG0004
- ParticipantsOG00128

Title	Measurements
	OG00025.0(0.63 to 80.59) OG001

Week 36: GH: ≥ 1 - ≤ 2.5 μg/L @ screening

- ParticipantsOG0004
- ParticipantsOG00128

Title	Measurements
	OG00025.0(0.63 to 80.59) OG001

Week 12: GH: > 2.5 μg/L @ screening

- ParticipantsOG00013
- ParticipantsOG00194

Title	Measurements
	OG0007.7(0.19 to 36.03) OG001

Week 24: GH: > 2.5 μg/L @ screening

- ParticipantsOG00013
- ParticipantsOG00194

Title	Measurements
	OG0007.7(0.19 to 36.03) OG001

Week 36: GH: > 2.5 μg/L @ screening

- ParticipantsOG00013
- ParticipantsOG00194

Title	Measurements
	OG0007.7(0.19 to 36.03) OG001

Week 12: GH: Missing

- ParticipantsOG0000
- ParticipantsOG0011

Title	Measurements
	OG0010.0(0.00 to 97.50)

Week 24: GH: Missing

- ParticipantsOG0000
- ParticipantsOG0011

Title	Measurements
	OG0010.0(0.00 to 97.50)

Week 36: GH: Missing

- ParticipantsOG0000
- ParticipantsOG0011

Title	Measurements
	OG0010.0(0.00 to 97.50)

Title

Denominators

Categories

Week 12

Title	Measurements
	OG00035.7(18.64 to 55.93) OG00116.0(9.22 to 24.95) OG0020.0(0.00 to 97.50) OG00320.3(13.61 to 28.52)

Week 24

Title	Measurements
	OG00042.9(24.46 to 62.82) OG00123.4(15.29 to 33.26) OG0020.0(0.00 to 97.50) OG003

Week 36

Title	Measurements
	OG00050.0(30.65 to 69.35) OG00125.5(17.09 to 35.57) OG0020.0(0.00 to 97.50) OG003

Title

Denominators

Categories

Week 12

Title	Measurements
	OG00013.5(5.59 to 25.79) OG00110.0(3.76 to 20.51) OG0020.0(0.00 to 28.49)

Week 24

Title	Measurements
	OG00013.5(5.59 to 25.79) OG00113.3(5.94 to 24.59) OG0029.1(0.23 to 41.28)

Week 36

Title	Measurements
	OG00015.4(6.88 to 28.08) OG00116.7(8.29 to 28.52) OG0020.0(0.00 to 28.49)

Title

Denominators

Categories

Week 12

- ParticipantsOG000120
- ParticipantsOG001120
- ParticipantsOG002120
- ParticipantsOG003120
- ParticipantsOG004118

Title	Measurements
	OG0004.5± 9.52 OG0015.3± 12.93 OG0024.1± 10.05 OG003

Week 24

- ParticipantsOG000118
- ParticipantsOG001118
- ParticipantsOG002118
- ParticipantsOG003118

Week 36

- ParticipantsOG000110
- ParticipantsOG001110
- ParticipantsOG002109
- ParticipantsOG003110

Title

Denominators

Categories

Week 12: Non/absent

- ParticipantsOG000119
- ParticipantsOG001119
- ParticipantsOG002119
- ParticipantsOG003119
- ParticipantsOG004119

Title	Measurements
	OG00056.9 OG00137.4 OG00256.9 OG003

Week 12: Mild

- ParticipantsOG000119
- ParticipantsOG001119
- ParticipantsOG002119
- ParticipantsOG003119

Week 12: Moderate

- ParticipantsOG000119
- ParticipantsOG001119
- ParticipantsOG002119
- ParticipantsOG003119

Week 12: Severe

- ParticipantsOG000119
- ParticipantsOG001119
- ParticipantsOG002119
- ParticipantsOG003119

Week 12: Very severe

- ParticipantsOG000119
- ParticipantsOG001119
- ParticipantsOG002119
- ParticipantsOG003119

Week 12: Not done

- ParticipantsOG000119
- ParticipantsOG001119
- ParticipantsOG002119
- ParticipantsOG003119

Week 24: Non/absent

- ParticipantsOG000119
- ParticipantsOG001119
- ParticipantsOG002119
- ParticipantsOG003119

Week 24: Mild

- ParticipantsOG000119
- ParticipantsOG001119
- ParticipantsOG002119
- ParticipantsOG003119

Week 24: Moderate

- ParticipantsOG000119
- ParticipantsOG001119
- ParticipantsOG002119
- ParticipantsOG003119

Week 24: Severe

- ParticipantsOG000119
- ParticipantsOG001119
- ParticipantsOG002119
- ParticipantsOG003119

Week 24: Very severe

- ParticipantsOG000119
- ParticipantsOG001119
- ParticipantsOG002119
- ParticipantsOG003119

Week 24: Not done

- ParticipantsOG000119
- ParticipantsOG001119
- ParticipantsOG002119
- ParticipantsOG003119

Week 36: Non/absent

- ParticipantsOG000113
- ParticipantsOG001113
- ParticipantsOG002113
- ParticipantsOG003113

Week 36: Mild

- ParticipantsOG000113
- ParticipantsOG001113
- ParticipantsOG002113
- ParticipantsOG003113

Week 36: Moderate

- ParticipantsOG000113
- ParticipantsOG001113
- ParticipantsOG002113
- ParticipantsOG003113

Week 36: Severe

- ParticipantsOG000113
- ParticipantsOG001113
- ParticipantsOG002113
- ParticipantsOG003113

Week 36: Very severe

- ParticipantsOG000113
- ParticipantsOG001113
- ParticipantsOG002113
- ParticipantsOG003113

Week 36: Not done

- ParticipantsOG000113
- ParticipantsOG001113
- ParticipantsOG002113
- ParticipantsOG003113

Title

Denominators

Categories

Baseline (BL): Non/absent

- ParticipantsOG00051
- ParticipantsOG00145
- ParticipantsOG00253
- ParticipantsOG00341
- ParticipantsOG00467

Title	Measurements
	OG00041.5 OG00136.6 OG00243.1 OG003

BL: Mild

- ParticipantsOG00031
- ParticipantsOG00123
- ParticipantsOG00231
- ParticipantsOG00326

BL: Moderate

- ParticipantsOG00023
- ParticipantsOG00132
- ParticipantsOG00223
- ParticipantsOG00332

BL: Severe

- ParticipantsOG00011
- ParticipantsOG00117
- ParticipantsOG00211
- ParticipantsOG00320

BL: Very severe

- ParticipantsOG0007
- ParticipantsOG0016
- ParticipantsOG0025
- ParticipantsOG0034

BL: Not done

- ParticipantsOG0000
- ParticipantsOG0010
- ParticipantsOG0020
- ParticipantsOG0030

BL: Total

- ParticipantsOG000123
- ParticipantsOG001123
- ParticipantsOG002123
- ParticipantsOG003123

Most extr post-BL:tot Non/absent

- ParticipantsOG00045
- ParticipantsOG00132
- ParticipantsOG00246
- ParticipantsOG00333

Most extr. post-BL: total Mild

- ParticipantsOG00038
- ParticipantsOG00128
- ParticipantsOG00236
- ParticipantsOG00332

Most extr. post-BL: total Mod.

- ParticipantsOG00025
- ParticipantsOG00128
- ParticipantsOG00225
- ParticipantsOG00330

Most extr. post-BL: total Severe

- ParticipantsOG00012
- ParticipantsOG00119
- ParticipantsOG0029
- ParticipantsOG00318

Most extr post-BL:tot. Very severe

- ParticipantsOG0003
- ParticipantsOG00116
- ParticipantsOG0027
- ParticipantsOG00310

Most extr. post-BL: total Not done

- ParticipantsOG0000
- ParticipantsOG0010
- ParticipantsOG0020
- ParticipantsOG0030

Title

Denominators

Categories

Week 12

- ParticipantsOG000119

Title	Measurements
	OG0000.0± 0.15

Week 24

- ParticipantsOG000118

Title	Measurements
	OG0000.0± 0.15

Week 36

- ParticipantsOG000111

Title	Measurements
	OG0000.0± 0.15

Title

Denominators

Categories

Week 12

- ParticipantsOG000119

Title	Measurements
	OG0004.1± 14.91

Week 24

- ParticipantsOG000118

Title	Measurements
	OG0003.4± 13.49

Week 36

- ParticipantsOG000111

Title	Measurements
	OG0004.9± 15.24

Title

Denominators

Categories

Week 48: Diabetic

- ParticipantsOG00043

Title	Measurements
	OG00011.6(3.89 to 25.08)

Week 60: Diabetic

- ParticipantsOG00043

Title	Measurements
	OG00011.6(3.89 to 25.08)

Week 72: Diabetic

- ParticipantsOG00043

Title	Measurements
	OG00011.6(3.89 to 25.08)

Week 48: Pre-diabetic

- ParticipantsOG00036

Title	Measurements
	OG00011.1(3.11 to 26.06)

Week 60: Pre-diabetic

- ParticipantsOG00036

Title	Measurements
	OG00016.7(6.37 to 32.81)

Week 72: Pre-diabetic

- ParticipantsOG00036

Title	Measurements
	OG0008.3(1.75 to 22.47)

Week 48: Non-diabetic

- ParticipantsOG0009

Title	Measurements
	OG00022.2(2.81 to 60.01)

Week 60: Non-diabetic

- ParticipantsOG0009

Title	Measurements
	OG00022.2(2.81 to 60.01)

Week 72: Non-diabetic

- ParticipantsOG0009

Title	Measurements
	OG00022.2(2.81 to 60.01)

Title

Denominators

Categories

Wk48:GH: >= 1 - <= 2.5 μg/L at screen.

- ParticipantsOG00017
- ParticipantsOG0013
- ParticipantsOG00220

Title	Measurements
	OG00076.5(50.10 to 93.19) OG0010.0(0.00 to 70.76) OG00265.0(40.78 to 84.61)

Wk60:GH: >= 1 - <= 2.5 μg/L at screen.

- ParticipantsOG00017
- ParticipantsOG0013
- ParticipantsOG00220

Title	Measurements
	OG000

Wk72:GH: >= 1 - <= 2.5 μg/L at screen.

- ParticipantsOG00017
- ParticipantsOG0013
- ParticipantsOG00220

Title	Measurements
	OG000

Wk48: GH: > 2.5 μg/L at screening

- ParticipantsOG00059
- ParticipantsOG0019
- ParticipantsOG00268

Title	Measurements
	OG000

Wk60: GH: > 2.5 μg/L at screening

- ParticipantsOG00059
- ParticipantsOG0019
- ParticipantsOG00268

Title	Measurements
	OG000

Wk72: GH: > 2.5 μg/L at screening

- ParticipantsOG00059
- ParticipantsOG0019
- ParticipantsOG00268

Title	Measurements
	OG000

Week 48: Pasireotide LAR overall

- ParticipantsOG00076
- ParticipantsOG00112
- ParticipantsOG00288

Title	Measurements
	OG000

Week 60: Pasireotide LAR overall

- ParticipantsOG00076
- ParticipantsOG00112
- ParticipantsOG00288

Title	Measurements
	OG000

Week 72: Pasireotide LAR overall

- ParticipantsOG00076
- ParticipantsOG00112
- ParticipantsOG00288

Title	Measurements
	OG000

Title	Denominators	Categories
Week 48	ParticipantsOG0000 ParticipantsOG0010 ParticipantsOG0020 ParticipantsOG0030 ParticipantsOG0040
Week 60	ParticipantsOG0001 ParticipantsOG0011 ParticipantsOG0021 ParticipantsOG0031
Week 72	ParticipantsOG00074 ParticipantsOG00174 ParticipantsOG00273 ParticipantsOG00374

Title

Denominators

Categories

Week 48: None/absent

- ParticipantsOG00081
- ParticipantsOG00181
- ParticipantsOG00281
- ParticipantsOG00381
- ParticipantsOG00481

Title	Measurements
	OG00063.6 OG00159.1 OG00269.3 OG003

Week 48: Mild

- ParticipantsOG00081
- ParticipantsOG00181
- ParticipantsOG00281
- ParticipantsOG00381

Week 48: Moderate

- ParticipantsOG00081
- ParticipantsOG00181
- ParticipantsOG00281
- ParticipantsOG00381

Week 48: Severe

- ParticipantsOG00081
- ParticipantsOG00181
- ParticipantsOG00281
- ParticipantsOG00381

Week 48: Very severe

- ParticipantsOG00081
- ParticipantsOG00181
- ParticipantsOG00281
- ParticipantsOG00381

Week 48: Not done

- ParticipantsOG00081
- ParticipantsOG00181
- ParticipantsOG00281
- ParticipantsOG00381

Week 60: None/absent

- ParticipantsOG00077
- ParticipantsOG00177
- ParticipantsOG00277
- ParticipantsOG00377

Week 60: Mild

- ParticipantsOG00077
- ParticipantsOG00177
- ParticipantsOG00277
- ParticipantsOG00377

Week 60: Moderate

- ParticipantsOG00077
- ParticipantsOG00177
- ParticipantsOG00277
- ParticipantsOG00377

Week 60: Severe

- ParticipantsOG00077
- ParticipantsOG00177
- ParticipantsOG00277
- ParticipantsOG00377

Week 60: Very severe

- ParticipantsOG00077
- ParticipantsOG00177
- ParticipantsOG00277
- ParticipantsOG00377

Week 60: Not done

- ParticipantsOG00077
- ParticipantsOG00177
- ParticipantsOG00277
- ParticipantsOG00377

Week 72: None/absent

- ParticipantsOG00074
- ParticipantsOG00174
- ParticipantsOG00274
- ParticipantsOG00374

Week 72: Mild

- ParticipantsOG00074
- ParticipantsOG00174
- ParticipantsOG00274
- ParticipantsOG00374

Week 72: Moderate

- ParticipantsOG00074
- ParticipantsOG00174
- ParticipantsOG00274
- ParticipantsOG00374

Week 72: Severe

- ParticipantsOG00074
- ParticipantsOG00174
- ParticipantsOG00274
- ParticipantsOG00374

Week 72: Very severe

- ParticipantsOG00074
- ParticipantsOG00174
- ParticipantsOG00274
- ParticipantsOG00374

Week 72: Not done

- ParticipantsOG00074
- ParticipantsOG00174
- ParticipantsOG00274
- ParticipantsOG00374

Title

Denominators

Categories

Ext. Baseline (BL): Non/absent

- ParticipantsOG00061
- ParticipantsOG00150
- ParticipantsOG00260
- ParticipantsOG00346
- ParticipantsOG00470

Title	Measurements
	OG00069.3 OG00156.8 OG00268.2 OG003

Ext. BL: Mild

- ParticipantsOG00018
- ParticipantsOG00121
- ParticipantsOG00218
- ParticipantsOG00327

Ext. BL: Moderate

- ParticipantsOG0008
- ParticipantsOG00111
- ParticipantsOG0029
- ParticipantsOG00311

Ext. BL: Severe

- ParticipantsOG0001
- ParticipantsOG0014
- ParticipantsOG0021
- ParticipantsOG0033

Ext. BL: Very severe

- ParticipantsOG0000
- ParticipantsOG0012
- ParticipantsOG0020
- ParticipantsOG0031

Ext. BL: Not done

- ParticipantsOG0000
- ParticipantsOG0010
- ParticipantsOG0020
- ParticipantsOG0030

Ext. BL: Total

- ParticipantsOG00088
- ParticipantsOG00188
- ParticipantsOG00288
- ParticipantsOG00388

Most extr. post-BL:tot Non/absent

- ParticipantsOG00041
- ParticipantsOG00145
- ParticipantsOG00248
- ParticipantsOG00338

Most extr. post-BL: total Mild

- ParticipantsOG00026
- ParticipantsOG00120
- ParticipantsOG00223
- ParticipantsOG00329

Most extr. post-BL: total Mod.

- ParticipantsOG00016
- ParticipantsOG00116
- ParticipantsOG00213
- ParticipantsOG00312

Most extr. post-BL: total Severe

- ParticipantsOG0003
- ParticipantsOG0016
- ParticipantsOG0024
- ParticipantsOG0037

Most extr. post-BL: tot. Very severe

- ParticipantsOG0002
- ParticipantsOG0011
- ParticipantsOG0020
- ParticipantsOG0032

Most extr. post-BL: total Not done

- ParticipantsOG0000
- ParticipantsOG0010
- ParticipantsOG0020
- ParticipantsOG0030

ID	Term
D000172	Acromegaly
D006130	Growth Disorders
D005877	Gigantism
D010911	Pituitary Neoplasms