Acromegaly
Conditions
Keywords
acromegaly, GH, IGF-1, pasireotide LAR, SOM230, first generation, somatostatin analogues, growth disorder, gigantism, Pituitary adenoma, pituitary gigantism
Brief summary
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 approved doses of first generation somatostatin analogues. The study will enroll inadequately controlled patients by high doses (maximal approved) of first-generation somatostatin analogues given for at least 3 months. Patients will receive pasireotide LAR 40 mg or 60 mg during the 36 week core study phase. Patients who have completed all visits of core phase and have completed all the assessments at the core phase completion visit can move into the 32-week extension phase. Patients can continue with study treatment until pasireotide LAR is commercially available and reimbursed in their respective country or until the end of the extension phase whichever occurs first.
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.
Interventions
DRUGPasireotide LAR
Pasireotide 40 mg and 60 mg. Pasireotide 20 mg which was allowed for dose decrease in case of adverse event.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall | Week 36 | Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at 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 | Week 36 | Percentage 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. |
| Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 | Wek 36 | Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at 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 | Week 36 | Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, overall by baseline diabetic status. |
| Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall - LOCF | Week 36 | Percentage 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Baseline, Weeks 12, 24 & 36 | 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. |
| Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Weeks 12, 24 & 36 | 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). |
| Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Weeks 12, 24 & 36 | 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). |
| Core Phase: Change From Baseline in EQ-5D-5L Index Scores | Baseline, Weeks 12, 24 & 36 | 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. |
| Core Phase: Change From Baseline in EQ-5D-5L VAS Assessment | Baseline, Weeks 12, 24 & 36 | 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. |
| 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) | Weeks 48, 60 & 72 | Percentage of patients achieving IGF-1 \<ULN at weeks 48, 60 & 72 for participants with up-titrated to Pasireotide LAR 60 mg mg |
| Core Phase: Change in Mean Growth Hormone (GH) Values From Baseline to Week 36 | Baseline, week 36 | Core phase - Changes in mean GH from study baseline to week 36. |
| 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 | Weeks 48, 60, 72 | Percentage 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 |
| Extension Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Baseline, Weeks 48, 60 & 72 | 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. |
| Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Weeks 48, 60 & 72 | 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). |
| Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Weeks 48, 60 & 72 | 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). |
| Extension Phase: Change From Baseline in EQ-5D-5L Index Scores | Baseline, Weeks 48, 60 & 72 | 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. |
| Extension Phase: Change From Baseline in EQ-5D-5L VAS Assessment | Baseline, Weeks 48, 60 & 72 | 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. |
| 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) | Weeks 48, 60, 72 | Percentage of participants achieving IGF-1 \<ULN at week 46, 60 and 72 overall by baseline diabetic status |
| Core Phase: Change in Standardized IGF-1 Values From Baseline to Week 36 | Baseline, week 36 | Core phase - Changes in standardized IGF-1 from study baseline to week 36. |
| Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN | Week 12, Week 24, Week 36 | Percentage of participants achieving GH \<1 μg/L and IGF-1 \<ULN at weeks 12 and 24 overall and by GH level at screening. |
| Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening | Weeks 12, 24 & 36 | Percentage of participants achieving IGF-1 \<ULN at weeks 12, 24 & 36. |
| Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN Overall by Baseline Diabetic Status | Weeks 12, 24 & 36 | Core phase - Percentage of patients achieving GH \<1μg/L at week 12, 24, 36 overall and by GH level at screening. |
Countries
Argentina, Belgium, Brazil, Bulgaria, China, Colombia, France, Hungary, Italy, Malaysia, Mexico, Portugal, Romania, Turkey (Türkiye), United Kingdom
Participant flow
Recruitment details
Planned 112 participants and analyzed 123 participants. For Participant Flow/Baseline Characteristics Tables, Total = Participants in the Pasireotide LAR arm.
Pre-assignment details
Participants were allocated to Group 1 or Group 2 based on previously received first generation Somatostatin analog (SSA).
Participants by arm
| Arm | Count |
|---|---|
| Lanreotide 120 mg Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). | 41 |
| Octreotide 30 mg Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). . | 29 |
| 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). | 53 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Period 1: Core Phase | Adverse Event | 1 | 1 | 2 |
| Period 1: Core Phase | Unsatisfactory therapeutic effect | 1 | 0 | 2 |
| Period 1: Core Phase | Withdrawal by Subject | 0 | 1 | 2 |
| Period 2: Extension Phase | Physician Decision | 5 | 0 | 1 |
| Period 2: Extension Phase | Unsatisfactory therapeutic effect | 1 | 3 | 2 |
| Period 2: Extension Phase | Withdrawal by Subject | 0 | 1 | 0 |
| Period 3: Post-treatment Follow up Phase | Physician Decision | 3 | 0 | 1 |
| Period 3: Post-treatment Follow up Phase | Unsatisfactory therapeutic effect | 1 | 2 | 2 |
| Period 3: Post-treatment Follow up Phase | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Lanreotide 120 mg | Octreotide 30 mg | Octreotide 40 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 41.8 years STANDARD_DEVIATION 10.02 | 41.6 years STANDARD_DEVIATION 12.89 | 46.6 years STANDARD_DEVIATION 11.63 | 43.8 years STANDARD_DEVIATION 11.6 |
| Race/Ethnicity, Customized Asian | 1 Participants | 7 Participants | 3 Participants | 11 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 34 Participants | 14 Participants | 30 Participants | 78 Participants |
| Race/Ethnicity, Customized Native American | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 7 Participants | 19 Participants | 30 Participants |
| Sex: Female, Male Female | 19 Participants | 18 Participants | 25 Participants | 62 Participants |
| Sex: Female, Male Male | 22 Participants | 11 Participants | 28 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 92 | 0 / 123 |
| other Total, other adverse events | 83 / 92 | 112 / 123 |
| serious Total, serious adverse events | 6 / 92 | 12 / 123 |
Outcome results
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 \<ULN at week 36.
Time frame: Wek 36
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 | 15.7 Percentage of participants |
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 \<ULN at week 36, by previous treatment, type of therapy and overall.
Time frame: Week 36
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 | 7.7 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 | 13.0 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 | 20.5 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 | 17.1 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 | 0.0 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 | 14.8 Percentage of participants |
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 \<ULN at week 36.
Time frame: Week 36
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall | 14.6 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall | 13.8 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall | 15.1 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall | 14.6 Percentage of participants |
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 \<ULN at week 36, by previous treatment and overall - last observation carried forward (LOCF)
Time frame: Week 36
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall - LOCF | 14.6 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall - LOCF | 13.8 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall - LOCF | 17.0 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall - LOCF | 15.4 Percentage of participants |
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 \<ULN at week 36, for participants who had been up-titrated with pasireotide LAR 60 mg.
Time frame: Week 36
Population: 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 any time during the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lanreotide 120 mg | 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 | 5.9 Percentage of participants |
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 \<ULN at week 36, for participants who had been up-titrated with pasireotide LAR 60 mg.
Time frame: Week 36
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lanreotide 120 mg | 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 | 6.7 Percentage of participants |
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 \<ULN at week 36, overall by baseline diabetic status.
Time frame: Week 36
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 Overall by Baseline Diabetic Status | Diabetic | 14.0 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 Overall by Baseline Diabetic Status | Pre-diabetic | 19.4 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 Overall by Baseline Diabetic Status | Non-diabetic | 0.0 Percentage of participants |
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.
Time frame: Baseline, Weeks 12, 24 & 36
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lanreotide 120 mg | Core Phase: Change From Baseline in EQ-5D-5L Index Scores | Week 12 | 0.0 scores on a scale | Standard Deviation 0.15 |
| Lanreotide 120 mg | Core Phase: Change From Baseline in EQ-5D-5L Index Scores | Week 24 | 0.0 scores on a scale | Standard Deviation 0.15 |
| Lanreotide 120 mg | Core Phase: Change From Baseline in EQ-5D-5L Index Scores | Week 36 | 0.0 scores on a scale | Standard Deviation 0.15 |
Secondary
Core Phase: Change From Baseline in EQ-5D-5L VAS Assessment
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.
Time frame: Baseline, Weeks 12, 24 & 36
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lanreotide 120 mg | Core Phase: Change From Baseline in EQ-5D-5L VAS Assessment | Week 12 | 4.1 scores on a scale | Standard Deviation 14.91 |
| Lanreotide 120 mg | Core Phase: Change From Baseline in EQ-5D-5L VAS Assessment | Week 24 | 3.4 scores on a scale | Standard Deviation 13.49 |
| Lanreotide 120 mg | Core Phase: Change From Baseline in EQ-5D-5L VAS Assessment | Week 36 | 4.9 scores on a scale | Standard Deviation 15.24 |
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.
Time frame: Baseline, Weeks 12, 24 & 36
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lanreotide 120 mg | Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 12 | 4.5 scores on a scale | Standard Deviation 9.52 |
| Lanreotide 120 mg | Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 36 | 4.6 scores on a scale | Standard Deviation 10.14 |
| Lanreotide 120 mg | Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 24 | 4.7 scores on a scale | Standard Deviation 9.88 |
| Octreotide 30 mg | Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 24 | 5.8 scores on a scale | Standard Deviation 12.26 |
| Octreotide 30 mg | Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 12 | 5.3 scores on a scale | Standard Deviation 12.93 |
| Octreotide 30 mg | Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 36 | 5.4 scores on a scale | Standard Deviation 13 |
| Octreotide 40 mg | Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 24 | 4.0 scores on a scale | Standard Deviation 10.72 |
| Octreotide 40 mg | Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 12 | 4.1 scores on a scale | Standard Deviation 10.05 |
| Octreotide 40 mg | Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 36 | 4.3 scores on a scale | Standard Deviation 11.02 |
| Pasireotide LAR Overall | Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 12 | 6.5 scores on a scale | Standard Deviation 12.43 |
| Pasireotide LAR Overall | Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 36 | 7.0 scores on a scale | Standard Deviation 15.33 |
| Pasireotide LAR Overall | Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 24 | 7.2 scores on a scale | Standard Deviation 14.44 |
| Pasireotide With Concomitant Medication | Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 24 | 0.9 scores on a scale | Standard Deviation 10.7 |
| Pasireotide With Concomitant Medication | Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 12 | 1.9 scores on a scale | Standard Deviation 12.04 |
| Pasireotide With Concomitant Medication | Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 36 | 1.8 scores on a scale | Standard Deviation 10.69 |
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.
Time frame: Baseline, week 36
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lanreotide 120 mg | Core Phase: Change in Mean Growth Hormone (GH) Values From Baseline to Week 36 | -7.7 percentage change | Standard Deviation 19.51 |
| Octreotide 30 mg | Core Phase: Change in Mean Growth Hormone (GH) Values From Baseline to Week 36 | -8.5 percentage change | Standard Deviation 24.41 |
| Octreotide 40 mg | Core Phase: Change in Mean Growth Hormone (GH) Values From Baseline to Week 36 | -2.9 percentage change | Standard Deviation 4.21 |
| Pasireotide LAR Overall | Core Phase: Change in Mean Growth Hormone (GH) Values From Baseline to Week 36 | -6.0 percentage change | Standard Deviation 17.1 |
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.
Time frame: Baseline, week 36
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lanreotide 120 mg | Core Phase: Change in Standardized IGF-1 Values From Baseline to Week 36 | -1.1 percentage change | Standard Deviation 1.18 |
| Octreotide 30 mg | Core Phase: Change in Standardized IGF-1 Values From Baseline to Week 36 | -0.8 percentage change | Standard Deviation 0.78 |
| Octreotide 40 mg | Core Phase: Change in Standardized IGF-1 Values From Baseline to Week 36 | -1.1 percentage change | Standard Deviation 1.39 |
| Pasireotide LAR Overall | Core Phase: Change in Standardized IGF-1 Values From Baseline to Week 36 | -1.0 percentage change | Standard Deviation 1.18 |
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).
Time frame: Weeks 12, 24 & 36
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lanreotide 120 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Very severe | 0.0 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Not done | 0.0 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Mild | 27.6 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Non/absent | 59.3 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Not done | 0.0 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Mild | 24.4 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Non/absent | 63.4 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Very severe | 0.0 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Severe | 1.6 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Moderate | 9.8 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Mild | 17.1 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Not done | 0.0 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Very severe | 0.0 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Severe | 0.8 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Moderate | 14.6 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Severe | 1.6 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Moderate | 8.1 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Non/absent | 56.9 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Mild | 20.3 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Non/absent | 37.4 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Mild | 26.8 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Severe | 8.9 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Very severe | 4.9 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Not done | 0.0 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Non/absent | 46.3 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Moderate | 17.9 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Non/absent | 47.2 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Severe | 7.3 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Very severe | 4.9 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Not done | 0.0 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Mild | 23.6 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Moderate | 13.0 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Severe | 4.9 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Very severe | 3.3 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Not done | 0.0 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Moderate | 18.7 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Very severe | 0.0 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Non/absent | 56.9 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Not done | 0.0 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Very severe | 1.6 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Mild | 18.7 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Non/absent | 61.8 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Severe | 3.3 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Not done | 0.0 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Moderate | 8.1 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Non/absent | 64.2 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Severe | 1.6 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Moderate | 8.9 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Not done | 0.0 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Mild | 26.8 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Severe | 4.1 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Very severe | 0.8 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Mild | 21.1 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Moderate | 7.3 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Non/absent | 43.1 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Severe | 8.9 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Moderate | 14.6 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Very severe | 2.4 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Severe | 3.3 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Very severe | 4.9 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Moderate | 14.6 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Not done | 0.0 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Non/absent | 47.2 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Mild | 26.8 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Not done | 0.0 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Moderate | 12.2 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Mild | 27.6 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Severe | 3.3 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Not done | 0.0 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Very severe | 2.4 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Mild | 26.8 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Non/absent | 47.2 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Very severe | 0.8 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Not done | 0.0 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Non/absent | 69.1 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Mild | 13.8 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Severe | 1.6 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Very severe | 1.6 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Moderate | 5.7 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Severe | 0.8 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Non/absent | 72.4 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Non/absent | 69.1 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Not done | 0.0 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Not done | 0.0 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Mild | 14.6 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Mild | 15.4 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Moderate | 7.3 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 24: Very severe | 2.4 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 12: Severe | 4.9 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms | Week 36: Moderate | 5.7 Percentage of participants |
Secondary
Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline
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).
Time frame: Weeks 12, 24 & 36
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Total | 100.0 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr post-BL:tot Non/absent | 36.6 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Baseline (BL): Non/absent | 41.5 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr. post-BL: total Mod. | 20.3 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Severe | 7 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr. post-BL: total Severe | 9.8 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr post-BL:tot. Very severe | 2.4 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Moderate | 18.7 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr. post-BL: total Mild | 30.9 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Very severe | 5.7 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Mild | 25.2 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Very severe | 4.9 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr post-BL:tot Non/absent | 26.0 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Total | 100.0 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Mild | 17.8 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Baseline (BL): Non/absent | 36.6 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr. post-BL: total Severe | 15.4 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Moderate | 26.0 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr post-BL:tot. Very severe | 13.0 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr. post-BL: total Mod. | 22.8 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Severe | 13.8 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr. post-BL: total Mild | 22.8 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Total | 100.0 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Baseline (BL): Non/absent | 43.1 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Mild | 25.2 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Moderate | 18.7 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Severe | 8.9 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Very severe | 4.1 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr. post-BL: total Mild | 29.3 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr. post-BL: total Mod. | 20.3 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr. post-BL: total Severe | 7.3 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr post-BL:tot. Very severe | 5.7 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr post-BL:tot Non/absent | 37.4 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Baseline (BL): Non/absent | 33.3 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Mild | 21.1 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr post-BL:tot. Very severe | 8.1 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr. post-BL: total Severe | 14.6 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Moderate | 26.0 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr. post-BL: total Mild | 26.0 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Total | 100.0 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr. post-BL: total Mod. | 24.4 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Severe | 16.3 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Very severe | 3.3 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr post-BL:tot Non/absent | 26.8 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Mild | 25.2 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Severe | 8.9 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr. post-BL: total Mild | 27.6 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Moderate | 10.6 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr post-BL:tot. Very severe | 2.4 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr. post-BL: total Mod. | 13.0 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr post-BL:tot Non/absent | 47.2 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Most extr. post-BL: total Severe | 9.8 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | Baseline (BL): Non/absent | 54.5 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Total | 100.0 Percentage of participants |
| Pasireotide With Concomitant Medication | Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline | BL: Very severe | 0.8 Percentage of participants |
Secondary
Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening
Percentage of participants achieving IGF-1 \<ULN at weeks 12, 24 & 36.
Time frame: Weeks 12, 24 & 36
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lanreotide 120 mg | Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening | Week 12 | 35.7 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening | Week 36 | 50.0 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening | Week 24 | 42.9 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening | Week 12 | 16.0 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening | Week 36 | 25.5 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening | Week 24 | 23.4 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening | Week 24 | 0.0 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening | Week 12 | 0.0 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening | Week 36 | 0.0 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening | Week 12 | 20.3 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening | Week 36 | 30.9 Percentage of participants |
| Pasireotide LAR Overall | Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening | Week 24 | 27.6 Percentage of participants |
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 \<ULN at weeks 12 and 24 overall and by GH level at screening.
Time frame: Week 12, Week 24, Week 36
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN | Week 24: GH: ≥ 1 - ≤ 2.5 μg/L @ screening | 25.0 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN | Week 36: GH: > 2.5 μg/L @ screening | 7.7 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN | Week 12: GH: > 2.5 μg/L @ screening | 7.7 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN | Week 36: GH: ≥ 1 - ≤ 2.5 μg/L @ screening | 25.0 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN | Week 24: GH: > 2.5 μg/L @ screening | 7.7 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN | Week 12: GH: ≥ 1 - ≤ 2.5 μg/L @ screening | 25.0 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN | Week 36: GH: > 2.5 μg/L @ screening | 6.4 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN | Week 12: GH: Missing | 0.0 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN | Week 24: GH: Missing | 0.0 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN | Week 36: GH: Missing | 0.0 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN | Week 12: GH: ≥ 1 - ≤ 2.5 μg/L @ screening | 28.6 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN | Week 24: GH: ≥ 1 - ≤ 2.5 μg/L @ screening | 39.3 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN | Week 36: GH: ≥ 1 - ≤ 2.5 μg/L @ screening | 42.9 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN | Week 12: GH: > 2.5 μg/L @ screening | 5.3 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN | Week 24: GH: > 2.5 μg/L @ screening | 5.3 Percentage of participants |
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.
Time frame: Weeks 12, 24 & 36
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN Overall by Baseline Diabetic Status | Week 12 | 13.5 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN Overall by Baseline Diabetic Status | Week 36 | 15.4 Percentage of participants |
| Lanreotide 120 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN Overall by Baseline Diabetic Status | Week 24 | 13.5 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN Overall by Baseline Diabetic Status | Week 36 | 16.7 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN Overall by Baseline Diabetic Status | Week 12 | 10.0 Percentage of participants |
| Octreotide 30 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN Overall by Baseline Diabetic Status | Week 24 | 13.3 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN Overall by Baseline Diabetic Status | Week 24 | 9.1 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN Overall by Baseline Diabetic Status | Week 12 | 0.0 Percentage of participants |
| Octreotide 40 mg | Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN Overall by Baseline Diabetic Status | Week 36 | 0.0 Percentage of participants |
Secondary
Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline
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).
Time frame: Weeks 48, 60 & 72
Population: Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lanreotide 120 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL: tot. Very severe | 2.3 Percentage of participants |
| Lanreotide 120 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL: total Mild | 29.5 Percentage of participants |
| Lanreotide 120 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL: total Mod. | 18.2 Percentage of participants |
| Lanreotide 120 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL: total Severe | 3.4 Percentage of participants |
| Lanreotide 120 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Moderate | 9.1 Percentage of participants |
| Lanreotide 120 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Severe | 1.1 Percentage of participants |
| Lanreotide 120 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Mild | 20.5 Percentage of participants |
| Lanreotide 120 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. Baseline (BL): Non/absent | 69.3 Percentage of participants |
| Lanreotide 120 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Total | 100.0 Percentage of participants |
| Lanreotide 120 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL:tot Non/absent | 46.6 Percentage of participants |
| Octreotide 30 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Mild | 23.9 Percentage of participants |
| Octreotide 30 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Moderate | 12.5 Percentage of participants |
| Octreotide 30 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. Baseline (BL): Non/absent | 56.8 Percentage of participants |
| Octreotide 30 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Very severe | 2.3 Percentage of participants |
| Octreotide 30 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL: tot. Very severe | 1.1 Percentage of participants |
| Octreotide 30 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Severe | 4.5 Percentage of participants |
| Octreotide 30 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL:tot Non/absent | 51.1 Percentage of participants |
| Octreotide 30 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL: total Mild | 22.7 Percentage of participants |
| Octreotide 30 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL: total Severe | 6.8 Percentage of participants |
| Octreotide 30 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Total | 100.0 Percentage of participants |
| Octreotide 30 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL: total Mod. | 18.2 Percentage of participants |
| Octreotide 40 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Moderate | 10.2 Percentage of participants |
| Octreotide 40 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL:tot Non/absent | 54.5 Percentage of participants |
| Octreotide 40 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL: total Mod. | 14.8 Percentage of participants |
| Octreotide 40 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL: total Mild | 26.1 Percentage of participants |
| Octreotide 40 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. Baseline (BL): Non/absent | 68.2 Percentage of participants |
| Octreotide 40 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Severe | 1.1 Percentage of participants |
| Octreotide 40 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL: total Severe | 4.5 Percentage of participants |
| Octreotide 40 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Mild | 20.5 Percentage of participants |
| Octreotide 40 mg | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Total | 100.0 Percentage of participants |
| Pasireotide LAR Overall | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL: tot. Very severe | 2.3 Percentage of participants |
| Pasireotide LAR Overall | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. Baseline (BL): Non/absent | 52.3 Percentage of participants |
| Pasireotide LAR Overall | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Mild | 30.7 Percentage of participants |
| Pasireotide LAR Overall | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Moderate | 12.5 Percentage of participants |
| Pasireotide LAR Overall | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Severe | 3.4 Percentage of participants |
| Pasireotide LAR Overall | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Very severe | 1.1 Percentage of participants |
| Pasireotide LAR Overall | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Total | 100.0 Percentage of participants |
| Pasireotide LAR Overall | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL:tot Non/absent | 43.2 Percentage of participants |
| Pasireotide LAR Overall | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL: total Mild | 33.0 Percentage of participants |
| Pasireotide LAR Overall | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL: total Severe | 8.0 Percentage of participants |
| Pasireotide LAR Overall | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL: total Mod. | 13.6 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL: total Severe | 2.3 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL:tot Non/absent | 67.0 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Total | 100.0 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Very severe | 1.1 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Moderate | 5.7 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL: tot. Very severe | 1.1 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL: total Mod. | 6.8 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. BL: Mild | 13.6 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Most extr. post-BL: total Mild | 22.7 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline | Ext. Baseline (BL): Non/absent | 79.5 Percentage of participants |
Secondary
Extension 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.
Time frame: Baseline, Weeks 48, 60 & 72
Population: Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lanreotide 120 mg | Extension Phase: Change From Baseline in EQ-5D-5L Index Scores | Week 60 | -0.1 scores on a scale | Standard Deviation 0 |
| Lanreotide 120 mg | Extension Phase: Change From Baseline in EQ-5D-5L Index Scores | Week 72 | 0.0 scores on a scale | Standard Deviation 0.08 |
| Unknown | Extension Phase: Change From Baseline in EQ-5D-5L Index Scores | Week 48 | — scores on a scale | — |
Secondary
Extension Phase: Change From Baseline in EQ-5D-5L VAS Assessment
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.
Time frame: Baseline, Weeks 48, 60 & 72
Population: Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lanreotide 120 mg | Extension Phase: Change From Baseline in EQ-5D-5L VAS Assessment | Week 60 | -10.0 scores on a scale | Standard Deviation 0 |
| Lanreotide 120 mg | Extension Phase: Change From Baseline in EQ-5D-5L VAS Assessment | Week 72 | 1.6 scores on a scale | Standard Deviation 9.14 |
| Unknown | Extension Phase: Change From Baseline in EQ-5D-5L VAS Assessment | Week 48 | — scores on a scale | — |
Secondary
Extension 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.
Time frame: Baseline, Weeks 48, 60 & 72
Population: Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lanreotide 120 mg | Extension Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 60 | -4.5 scores on a scale | Standard Deviation 0 |
| Lanreotide 120 mg | Extension Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 72 | 1.6 scores on a scale | Standard Deviation 9.72 |
| Octreotide 30 mg | Extension Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 60 | 0.0 scores on a scale | Standard Deviation 0 |
| Octreotide 30 mg | Extension Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 72 | 0.9 scores on a scale | Standard Deviation 10.61 |
| Octreotide 40 mg | Extension Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 72 | 1.8 scores on a scale | Standard Deviation 10.6 |
| Octreotide 40 mg | Extension Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 60 | -7.1 scores on a scale | Standard Deviation 0 |
| Pasireotide LAR Overall | Extension Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 60 | -3.6 scores on a scale | Standard Deviation 0 |
| Pasireotide LAR Overall | Extension Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 72 | 0.8 scores on a scale | Standard Deviation 12.82 |
| Pasireotide With Concomitant Medication | Extension Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 60 | -10.7 scores on a scale | Standard Deviation 0 |
| Pasireotide With Concomitant Medication | Extension Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 72 | 2.9 scores on a scale | Standard Deviation 11.82 |
| Unknown | Extension Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL) | Week 48 | — scores on a scale | — |
Secondary
Extension Phase: Percentage of Participants Reporting Levels 1 - 5 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).
Time frame: Weeks 48, 60 & 72
Population: Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lanreotide 120 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Mild | 17.0 Percentage of participants |
| Lanreotide 120 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: None/absent | 60.2 Percentage of participants |
| Lanreotide 120 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Very severe | 0.0 Percentage of participants |
| Lanreotide 120 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Severe | 2.3 Percentage of participants |
| Lanreotide 120 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Not done | 0.0 Percentage of participants |
| Lanreotide 120 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Mild | 19.3 Percentage of participants |
| Lanreotide 120 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Not done | 0.0 Percentage of participants |
| Lanreotide 120 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Moderate | 8.0 Percentage of participants |
| Lanreotide 120 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Mild | 17.0 Percentage of participants |
| Lanreotide 120 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: None/absent | 56.8 Percentage of participants |
| Lanreotide 120 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Moderate | 8.0 Percentage of participants |
| Lanreotide 120 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: None/absent | 63.6 Percentage of participants |
| Lanreotide 120 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Not done | 0.0 Percentage of participants |
| Lanreotide 120 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Very severe | 0.0 Percentage of participants |
| Lanreotide 120 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Severe | 3.4 Percentage of participants |
| Lanreotide 120 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Severe | 1.1 Percentage of participants |
| Lanreotide 120 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Very severe | 0.0 Percentage of participants |
| Lanreotide 120 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Moderate | 6.8 Percentage of participants |
| Octreotide 30 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Moderate | 12.5 Percentage of participants |
| Octreotide 30 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: None/absent | 59.1 Percentage of participants |
| Octreotide 30 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Mild | 17.0 Percentage of participants |
| Octreotide 30 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Severe | 3.4 Percentage of participants |
| Octreotide 30 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Very severe | 0.0 Percentage of participants |
| Octreotide 30 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Not done | 0.0 Percentage of participants |
| Octreotide 30 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: None/absent | 48.9 Percentage of participants |
| Octreotide 30 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Mild | 20.5 Percentage of participants |
| Octreotide 30 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Moderate | 13.6 Percentage of participants |
| Octreotide 30 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Severe | 4.5 Percentage of participants |
| Octreotide 30 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Very severe | 0.0 Percentage of participants |
| Octreotide 30 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Not done | 0.0 Percentage of participants |
| Octreotide 30 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: None/absent | 44.3 Percentage of participants |
| Octreotide 30 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Mild | 23.9 Percentage of participants |
| Octreotide 30 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Moderate | 10.2 Percentage of participants |
| Octreotide 30 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Severe | 4.5 Percentage of participants |
| Octreotide 30 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Very severe | 1.1 Percentage of participants |
| Octreotide 30 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Not done | 0.0 Percentage of participants |
| Octreotide 40 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Severe | 0.0 Percentage of participants |
| Octreotide 40 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Mild | 20.5 Percentage of participants |
| Octreotide 40 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Severe | 0.0 Percentage of participants |
| Octreotide 40 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: None/absent | 69.3 Percentage of participants |
| Octreotide 40 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Moderate | 6.8 Percentage of participants |
| Octreotide 40 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Very severe | 0.0 Percentage of participants |
| Octreotide 40 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Very severe | 0.0 Percentage of participants |
| Octreotide 40 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Moderate | 9.1 Percentage of participants |
| Octreotide 40 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Not done | 0.0 Percentage of participants |
| Octreotide 40 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Not done | 0.0 Percentage of participants |
| Octreotide 40 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: None/absent | 61.4 Percentage of participants |
| Octreotide 40 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Mild | 15.9 Percentage of participants |
| Octreotide 40 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Mild | 13.6 Percentage of participants |
| Octreotide 40 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Moderate | 6.8 Percentage of participants |
| Octreotide 40 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Severe | 0.0 Percentage of participants |
| Octreotide 40 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Very severe | 0.0 Percentage of participants |
| Octreotide 40 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Not done | 0.0 Percentage of participants |
| Octreotide 40 mg | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: None/absent | 60.2 Percentage of participants |
| Pasireotide LAR Overall | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Very severe | 1.1 Percentage of participants |
| Pasireotide LAR Overall | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: None/absent | 56.8 Percentage of participants |
| Pasireotide LAR Overall | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Severe | 1.1 Percentage of participants |
| Pasireotide LAR Overall | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Not done | 0.0 Percentage of participants |
| Pasireotide LAR Overall | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Not done | 0.0 Percentage of participants |
| Pasireotide LAR Overall | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Not done | 0.0 Percentage of participants |
| Pasireotide LAR Overall | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: None/absent | 51.1 Percentage of participants |
| Pasireotide LAR Overall | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Mild | 25.0 Percentage of participants |
| Pasireotide LAR Overall | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Mild | 20.5 Percentage of participants |
| Pasireotide LAR Overall | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Moderate | 10.2 Percentage of participants |
| Pasireotide LAR Overall | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Mild | 14.8 Percentage of participants |
| Pasireotide LAR Overall | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Very severe | 1.1 Percentage of participants |
| Pasireotide LAR Overall | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Severe | 3.4 Percentage of participants |
| Pasireotide LAR Overall | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Moderate | 11.4 Percentage of participants |
| Pasireotide LAR Overall | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Very severe | 1.1 Percentage of participants |
| Pasireotide LAR Overall | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: None/absent | 53.4 Percentage of participants |
| Pasireotide LAR Overall | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Severe | 3.4 Percentage of participants |
| Pasireotide LAR Overall | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Moderate | 9.1 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Moderate | 4.5 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Moderate | 5.7 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Severe | 1.1 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: None/absent | 70.5 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Mild | 10.2 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Not done | 0.0 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Mild | 14.8 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: None/absent | 71.6 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Very severe | 1.1 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Very severe | 1.1 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: None/absent | 67.0 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Very severe | 0.0 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Not done | 0.0 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Not done | 0.0 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 60: Moderate | 4.5 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 48: Severe | 0.0 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Mild | 11.4 Percentage of participants |
| Pasireotide With Concomitant Medication | Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms | Week 72: Severe | 0.0 Percentage of 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 \<ULN at weeks 48, 60 & 72 for participants with up-titrated to Pasireotide LAR 60 mg mg
Time frame: Weeks 48, 60 & 72
Population: Extension Full Analysis Set (Extension FAS) included all the patients who received at least one dose of pasireotide LAR in the extension phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lanreotide 120 mg | 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) | Week 48 | 5.8 Percentage of participants |
| Lanreotide 120 mg | 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) | Week 60 | 7.1 Percentage of participants |
| Lanreotide 120 mg | 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) | Week 72 | 5.7 Percentage of participants |
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 \<ULN at week 46, 60 and 72 overall by baseline diabetic status
Time frame: Weeks 48, 60, 72
Population: Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lanreotide 120 mg | 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) | Week 48: Diabetic | 11.6 Percentage of participants |
| Lanreotide 120 mg | 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) | Week 60: Diabetic | 11.6 Percentage of participants |
| Lanreotide 120 mg | 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) | Week 72: Diabetic | 11.6 Percentage of participants |
| Lanreotide 120 mg | 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) | Week 48: Pre-diabetic | 11.1 Percentage of participants |
| Lanreotide 120 mg | 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) | Week 60: Pre-diabetic | 16.7 Percentage of participants |
| Lanreotide 120 mg | 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) | Week 72: Pre-diabetic | 8.3 Percentage of participants |
| Lanreotide 120 mg | 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) | Week 48: Non-diabetic | 22.2 Percentage of participants |
| Lanreotide 120 mg | 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) | Week 60: Non-diabetic | 22.2 Percentage of participants |
| Lanreotide 120 mg | 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) | Week 72: Non-diabetic | 22.2 Percentage of participants |
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 \<ULN at week 48 by treatment with pasireotide LAR alone or with concomitant medications used to treat acromegaly
Time frame: Weeks 48, 60, 72
Population: Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lanreotide 120 mg | 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 | Wk48: GH: > 2.5 μg/L at screening | 11.9 Percentage of participants |
| Lanreotide 120 mg | 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 | Wk48:GH: >= 1 - <= 2.5 μg/L at screen. | 76.5 Percentage of participants |
| Lanreotide 120 mg | 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 | Week 72: Pasireotide LAR overall | 23.7 Percentage of participants |
| Lanreotide 120 mg | 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 | Wk60: GH: > 2.5 μg/L at screening | 11.9 Percentage of participants |
| Lanreotide 120 mg | 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 | Week 60: Pasireotide LAR overall | 25.0 Percentage of participants |
| Lanreotide 120 mg | 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 | Week 48: Pasireotide LAR overall | 26.3 Percentage of participants |
| Lanreotide 120 mg | 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 | Wk72:GH: >= 1 - <= 2.5 μg/L at screen. | 64.7 Percentage of participants |
| Lanreotide 120 mg | 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 | Wk60:GH: >= 1 - <= 2.5 μg/L at screen. | 70.6 Percentage of participants |
| Lanreotide 120 mg | 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 | Wk72: GH: > 2.5 μg/L at screening | 11.9 Percentage of participants |
| Octreotide 30 mg | 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 | Week 60: Pasireotide LAR overall | 0.0 Percentage of participants |
| Octreotide 30 mg | 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 | Wk48:GH: >= 1 - <= 2.5 μg/L at screen. | 0.0 Percentage of participants |
| Octreotide 30 mg | 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 | Wk60:GH: >= 1 - <= 2.5 μg/L at screen. | 0.0 Percentage of participants |
| Octreotide 30 mg | 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 | Wk72:GH: >= 1 - <= 2.5 μg/L at screen. | 0.0 Percentage of participants |
| Octreotide 30 mg | 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 | Wk48: GH: > 2.5 μg/L at screening | 11.1 Percentage of participants |
| Octreotide 30 mg | 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 | Wk60: GH: > 2.5 μg/L at screening | 0.0 Percentage of participants |
| Octreotide 30 mg | 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 | Week 48: Pasireotide LAR overall | 8.3 Percentage of participants |
| Octreotide 30 mg | 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 | Week 72: Pasireotide LAR overall | 0.0 Percentage of participants |
| Octreotide 30 mg | 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 | Wk72: GH: > 2.5 μg/L at screening | 0.0 Percentage of participants |
| Octreotide 40 mg | 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 | Week 48: Pasireotide LAR overall | 23.9 Percentage of participants |
| Octreotide 40 mg | 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 | Week 60: Pasireotide LAR overall | 21.6 Percentage of participants |
| Octreotide 40 mg | 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 | Wk48: GH: > 2.5 μg/L at screening | 11.8 Percentage of participants |
| Octreotide 40 mg | 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 | Wk60:GH: >= 1 - <= 2.5 μg/L at screen. | 60.0 Percentage of participants |
| Octreotide 40 mg | 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 | Week 72: Pasireotide LAR overall | 20.5 Percentage of participants |
| Octreotide 40 mg | 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 | Wk72:GH: >= 1 - <= 2.5 μg/L at screen. | 55.0 Percentage of participants |
| Octreotide 40 mg | 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 | Wk72: GH: > 2.5 μg/L at screening | 10.3 Percentage of participants |
| Octreotide 40 mg | 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 | Wk60: GH: > 2.5 μg/L at screening | 10.3 Percentage of participants |
| Octreotide 40 mg | 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 | Wk48:GH: >= 1 - <= 2.5 μg/L at screen. | 65.0 Percentage of participants |