Non-functioning Pituitary Adenoma
Conditions
Keywords
Non-functioning pituitary adenoma,, pasireotide LAR,, tumor volume
Brief summary
This study assessed pasireotide LAR efficacy on patients with non-functioning pituitary adenomas concerning tumor growth.
Interventions
DRUGPasireotide LAR
20 and 40 mg of powder in vials and 2 mL of vehicle in ampoules (for reconstitution) administered as a depot intragluteal IM (intramuscular) injection
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
* Non-functioning pituitary adenoma ≥ 1cm, patients without any previous treatment for the tumor * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion criteria
* Patients who required a surgical intervention for relief of any sign or symptom associated with tumor compression * Previous pituitary surgery * Previous medical treatment for pituitary tumor * Patients who had received pituitary irradiation within 10 years prior to randomization * Prolactin (PRL) levels \> 100 ng/mL. PRL evaluation should have been performed with diluted samples to ensure hook effect. was avoided * Patients who presented prolactinomas, acromegaly or Cushing's disease * Patients with compression of the optic chiasm causing acute clinically significant visual field defects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS) | Baseline up to 24 weeks | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility.The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. A change ≥ 20% in the original volume of the tumor was considered to be clinically significant. Evaluable participants required tumor volume assessment at baseline and at week 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Volume in Extension Phase (FAS) | baseline to week 48, 72, 96 | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. |
| Tumor Volume Change From Baseline in Main Phase (FAS) | baseline to week 4, 12, 24 | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. |
| Tumor Volume Change From Baseline in Extension Phase (FAS) | baseline to week 48, 72, 96 | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. |
| Tumor Volume Percent Change From Baseline in Main Phase (FAS) | baseline to week 4, 12, 24 | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. |
| Tumor Volume Percent Change From Baseline in Extension Phase (FAS) | baseline to week 48, 72, 96 | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. |
| Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS) | baseline to week 4, 12, 24 | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. |
| Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS) | baseline to week 4, 12, 24 | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. |
| Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS) | baseline to week 48, 72, 96 | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. |
| Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Extension Phase (FAS) | baseline to week 48, 72, 96 | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. |
| Tumor Volume Main Phase (FAS) | baseline to week 4, 12, 24 | Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. |
| Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS) | Baseline and at weeks 24, 48, 96 | Hormone levels, including those of GH, IGF-1, and prolactin were evaluated by a central lab |
| Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS) | Baseline and at weeks 24, 48, 96 | Hormone levels, including those of growth hormone (GH),insulin-like growth factor 1 (IGF-1), follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free thyroxine (free T4), and estradiol (for women) or testosterone (for men), were evaluated by a central lab |
| Mean Cortisol Hormone Levels During Main and Extension Phases (FAS) | Baseline and at weeks 24, 48, 96 | Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab |
| Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS) | Baseline and at weeks 24, 48, 96 | Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab |
| Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS) | Baseline and at weeks 24, 48, 96 | Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab |
| Mean TSH Hormone Levels During Main and Extension Phases (FAS) | Baseline and at weeks 24, 48, 96 | Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab |
| Mean Alpha Subunit Levels in Main and Extension Phases (FAS) | Baseline and at weeks 12,24,48,72, 96 | — |
| Percentage of Participants With Reduction From Baseline of Alpha Subunit ≥50% in Main and Extension Phases (FAS) | Baseline up to approximately Week 96 | Alpha subunit levels were determined at a central laboratory. |
| Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Baseline and at weeks 4, 12,24,48,72, 96 | The absence and presence of disease-related symptoms were reported by patients and recorded by the medical staff. Patients classified the symptoms according to a 5-point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe |
Countries
Brazil
Participant flow
Pre-assignment details
Twenty seven patients were screened and 21 met eligibility requirements.
Participants by arm
| Arm | Count |
|---|---|
| Pasireotide LAR All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Extension Phase | Administrative problems | 1 |
| Extension Phase | Adverse Event | 1 |
| Extension Phase | Physician Decision | 1 |
| Main Phase | abnormal laboratory values | 5 |
| Main Phase | Acute or progressive vision loss | 1 |
| Main Phase | Uncontrolled diabetes mellitus | 1 |
Baseline characteristics
| Characteristic | Pasireotide LAR |
|---|---|
| Age, Continuous | 55.65 years STANDARD_DEVIATION 11.72 |
| Body mass index (BMI) | 26.95 kg/m2 STANDARD_DEVIATION 4.53 |
| Race/Ethnicity, Customized Asian ancestry | 1 Participants |
| Race/Ethnicity, Customized Black/African ancestry | 5 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White/Caucasian ancestry | 13 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 17 / 20 |
| serious Total, serious adverse events | 2 / 20 |
Outcome results
Primary
Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility.The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. A change ≥ 20% in the original volume of the tumor was considered to be clinically significant. Evaluable participants required tumor volume assessment at baseline and at week 24.
Time frame: Baseline up to 24 weeks
Population: Evaluable participants required tumor volume assessment at baseline and at week 24
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pasireotide LAR | Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS) | 16.7 percentage of participants |
Secondary
Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS)
Hormone levels, including those of growth hormone (GH),insulin-like growth factor 1 (IGF-1), follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free thyroxine (free T4), and estradiol (for women) or testosterone (for men), were evaluated by a central lab
Time frame: Baseline and at weeks 24, 48, 96
Population: participants with evaluable data varied across visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pasireotide LAR | Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS) | ACTH | 28.91 pg/mL | Standard Deviation 37.07 |
| Pasireotide LAR | Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS) | Estradiol | 35.72 pg/mL | Standard Deviation 21.03 |
| Week 4 | Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS) | Estradiol | 32.12 pg/mL | Standard Deviation 17.71 |
| Week 4 | Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS) | ACTH | 23.18 pg/mL | Standard Deviation 31.67 |
| Week 12 | Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS) | ACTH | 36.06 pg/mL | Standard Deviation 33.09 |
| Week 12 | Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS) | Estradiol | 34.69 pg/mL | Standard Deviation 14.74 |
| Week 24 | Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS) | ACTH | 29.90 pg/mL | Standard Deviation 26.83 |
| Week 24 | Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS) | Estradiol | 19.98 pg/mL | Standard Deviation 15.78 |
Secondary
Mean Alpha Subunit Levels in Main and Extension Phases (FAS)
Time frame: Baseline and at weeks 12,24,48,72, 96
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pasireotide LAR | Mean Alpha Subunit Levels in Main and Extension Phases (FAS) | 242.27 ng/mL | Standard Deviation 286.9 |
| Week 4 | Mean Alpha Subunit Levels in Main and Extension Phases (FAS) | 309.04 ng/mL | Standard Deviation 270.52 |
| Week 12 | Mean Alpha Subunit Levels in Main and Extension Phases (FAS) | 192.11 ng/mL | Standard Deviation 201.25 |
| Week 24 | Mean Alpha Subunit Levels in Main and Extension Phases (FAS) | 234.21 ng/mL | Standard Deviation 182.59 |
| Week 48 | Mean Alpha Subunit Levels in Main and Extension Phases (FAS) | 286.78 ng/mL | Standard Deviation 288.62 |
| Week 72 | Mean Alpha Subunit Levels in Main and Extension Phases (FAS) | 435.00 ng/mL | Standard Deviation 310.87 |
Secondary
Mean Cortisol Hormone Levels During Main and Extension Phases (FAS)
Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab
Time frame: Baseline and at weeks 24, 48, 96
Population: number participants with evaluable data varied across visits
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pasireotide LAR | Mean Cortisol Hormone Levels During Main and Extension Phases (FAS) | 12.60 µg/dL | Standard Deviation 4.37 |
| Week 4 | Mean Cortisol Hormone Levels During Main and Extension Phases (FAS) | 16.41 µg/dL | Standard Deviation 8.28 |
| Week 12 | Mean Cortisol Hormone Levels During Main and Extension Phases (FAS) | 12.12 µg/dL | Standard Deviation 4.43 |
| Week 24 | Mean Cortisol Hormone Levels During Main and Extension Phases (FAS) | 10.09 µg/dL | Standard Deviation 3.12 |
Secondary
Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS)
Hormone levels, including those of GH, IGF-1, and prolactin were evaluated by a central lab
Time frame: Baseline and at weeks 24, 48, 96
Population: number of participants with evaluable data varied across visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pasireotide LAR | Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS) | GH | 0.31 ng/mL | Standard Deviation 0.63 |
| Pasireotide LAR | Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS) | Prolactin | 16.90 ng/mL | Standard Deviation 12.91 |
| Pasireotide LAR | Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS) | IGF-1 | 130.73 ng/mL | Standard Deviation 44.4 |
| Week 4 | Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS) | GH | 1.11 ng/mL | Standard Deviation 4.1 |
| Week 4 | Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS) | Prolactin | 13.89 ng/mL | Standard Deviation 17.32 |
| Week 4 | Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS) | IGF-1 | 72.59 ng/mL | Standard Deviation 35.55 |
| Week 12 | Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS) | IGF-1 | 66.23 ng/mL | Standard Deviation 31.46 |
| Week 12 | Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS) | GH | 0.15 ng/mL | Standard Deviation 0.15 |
| Week 12 | Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS) | Prolactin | 9.03 ng/mL | Standard Deviation 6.27 |
| Week 24 | Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS) | GH | 0.12 ng/mL | Standard Deviation 0.07 |
| Week 24 | Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS) | Prolactin | 7.62 ng/mL | Standard Deviation 8.33 |
| Week 24 | Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS) | IGF-1 | 70.82 ng/mL | Standard Deviation 32.67 |
Secondary
Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS)
Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab
Time frame: Baseline and at weeks 24, 48, 96
Population: participants with evaluable data varied across visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pasireotide LAR | Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS) | LH | 5.57 mUI/mL | Standard Deviation 6.91 |
| Pasireotide LAR | Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS) | FSH | 11.83 mUI/mL | Standard Deviation 18.89 |
| Week 4 | Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS) | FSH | 12.90 mUI/mL | Standard Deviation 20 |
| Week 4 | Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS) | LH | 5.32 mUI/mL | Standard Deviation 7.25 |
| Week 12 | Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS) | LH | 7.44 mUI/mL | Standard Deviation 7.07 |
| Week 12 | Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS) | FSH | 16.23 mUI/mL | Standard Deviation 20.97 |
| Week 24 | Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS) | LH | 9.95 mUI/mL | Standard Deviation 9.56 |
| Week 24 | Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS) | FSH | 21.45 mUI/mL | Standard Deviation 24.56 |
Secondary
Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS)
Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab
Time frame: Baseline and at weeks 24, 48, 96
Population: participants with evaluable data varied across visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pasireotide LAR | Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS) | Testosterone | 452.21 ng/dL | Standard Deviation 214.52 |
| Pasireotide LAR | Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS) | Free T4 | 1.07 ng/dL | Standard Deviation 0.12 |
| Week 4 | Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS) | Free T4 | 1.13 ng/dL | Standard Deviation 0.18 |
| Week 4 | Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS) | Testosterone | 372.72 ng/dL | Standard Deviation 205.25 |
| Week 12 | Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS) | Testosterone | 517.52 ng/dL | Standard Deviation 200.64 |
| Week 12 | Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS) | Free T4 | 1.17 ng/dL | Standard Deviation 0.17 |
| Week 24 | Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS) | Testosterone | 382.10 ng/dL | Standard Deviation 179.79 |
| Week 24 | Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS) | Free T4 | 1.04 ng/dL | Standard Deviation 0.25 |
Secondary
Mean TSH Hormone Levels During Main and Extension Phases (FAS)
Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab
Time frame: Baseline and at weeks 24, 48, 96
Population: participants with evaluable data varied across visits
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pasireotide LAR | Mean TSH Hormone Levels During Main and Extension Phases (FAS) | 151.81 µUI/mL | Standard Deviation 655.82 |
| Week 4 | Mean TSH Hormone Levels During Main and Extension Phases (FAS) | 149.92 µUI/mL | Standard Deviation 628.93 |
| Week 12 | Mean TSH Hormone Levels During Main and Extension Phases (FAS) | 1.67 µUI/mL | Standard Deviation 1.27 |
| Week 24 | Mean TSH Hormone Levels During Main and Extension Phases (FAS) | 1.70 µUI/mL | Standard Deviation 1.33 |
Secondary
Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS)
The absence and presence of disease-related symptoms were reported by patients and recorded by the medical staff. Patients classified the symptoms according to a 5-point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe
Time frame: Baseline and at weeks 4, 12,24,48,72, 96
Population: number of participants varied across visits
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Moderate | 25.0 percentage of participants |
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Severe | 0 percentage of participants |
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Moderate | 5.0 percentage of participants |
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Absent | 45.0 percentage of participants |
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Regular Menses Yes | 45.5 percentage of participants |
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Mild | 15.0 percentage of participants |
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Erectile dysfunction No | 77.8 percentage of participants |
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Severe | 0 percentage of participants |
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Erectile dysfunction Yes | 22.2 percentage of participants |
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Absent | 80.0 percentage of participants |
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Very severe | 10.0 percentage of participants |
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Mild | 10.0 percentage of participants |
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Regular Menses No | 54.5 percentage of participants |
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Severe | 5.0 percentage of participants |
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Moderate | 5.0 percentage of participants |
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Mild | 30.0 percentage of participants |
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Moderate | 20.0 percentage of participants |
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Severe | 5.0 percentage of participants |
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Mild | 10.0 percentage of participants |
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Absent | 80.0 percentage of participants |
| Pasireotide LAR | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Absent | 55.0 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Absent | 80.0 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Severe | 0 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Erectile dysfunction Yes | 11.1 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Severe | 5.0 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Absent | 80.0 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Regular Menses No | 44.4 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Very severe | 0 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Mild | 10.0 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Mild | 10.0 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Mild | 10.0 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Severe | 15.0 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Absent | 65.0 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Mild | 15.0 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Severe | 5.0 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Moderate | 5.0 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Moderate | 0 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Regular Menses Yes | 55.6 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Moderate | 10.0 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Moderate | 15.0 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Absent | 75.0 percentage of participants |
| Week 4 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Erectile dysfunction No | 88.9 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Regular Menses Yes | 62.5 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Moderate | 10.5 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Severe | 0 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Regular Menses No | 37.5 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Erectile dysfunction Yes | 11.1 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Mild | 21.1 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Absent | 52.6 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Severe | 0 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Severe | 0 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Absent | 84.2 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Moderate | 5.3 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Very severe | 0 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Absent | 73.7 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Moderate | 5.3 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Mild | 10.5 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Erectile dysfunction No | 88.9 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Mild | 10.5 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Moderate | 5.3 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Severe | 15.8 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Mild | 36.8 percentage of participants |
| Week 12 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Absent | 68.4 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Moderate | 5.0 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Absent | 45.0 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Mild | 45.0 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Moderate | 10.0 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Severe | 0 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Absent | 85.0 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Mild | 10.0 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Moderate | 5.0 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Severe | 0 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Absent | 75.0 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Mild | 20.0 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Severe | 0 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Absent | 65.0 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Mild | 10.0 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Moderate | 10.0 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Severe | 15.0 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Very severe | 0 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Erectile dysfunction Yes | 11.1 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Erectile dysfunction No | 88.9 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Regular Menses Yes | 55.6 percentage of participants |
| Week 24 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Regular Menses No | 44.4 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Moderate | 30.8 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Moderate | 0 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Mild | 7.7 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Moderate | 15.4 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Severe | 15.4 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Moderate | 0 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Severe | 0 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Regular Menses No | 40.0 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Erectile dysfunction No | 100.0 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Absent | 76.9 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Absent | 61.5 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Very severe | 0 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Mild | 30.8 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Mild | 23.1 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Regular Menses Yes | 60.0 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Severe | 0 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Severe | 0 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Absent | 61.5 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Erectile dysfunction Yes | 0 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Mild | 7.7 percentage of participants |
| Week 48 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Absent | 69.2 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Absent | 66.7 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Moderate | 33.3 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Erectile dysfunction No | 100.0 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Absent | 58.3 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Mild | 8.3 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Regular Menses No | 50.0 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Moderate | 8.3 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Moderate | 0 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Mild | 33.3 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Severe | 0 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Severe | 0 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Mild | 0 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Absent | 58.3 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Severe | 8.3 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Regular Menses Yes | 50.0 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Absent | 83.3 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Very severe | 0 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Mild | 25.0 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Severe | 0 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Erectile dysfunction Yes | 0 percentage of participants |
| Week 72 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Moderate | 16.7 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Severe | 0 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Absent | 70.0 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Severe | 0 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Regular Menses Yes | 50.0 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Mild | 0 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Moderate | 20.0 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Absent | 70.0 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Moderate | 20.0 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Mild | 0 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Severe | 10.0 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Visual Disturbances Absent | 80.0 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Decreased libido Very severe | 0 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Severe | 10.0 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Regular Menses No | 50.0 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Erectile dysfunction Yes | 0 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Moderate | 20.0 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Erectile dysfunction No | 100.0 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Headache Mild | 0.0 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Moderate | 0 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Mild | 30.0 percentage of participants |
| Week 96 | Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) | Fatigue Absent | 70.0 percentage of participants |
Secondary
Percentage of Participants With Reduction From Baseline of Alpha Subunit ≥50% in Main and Extension Phases (FAS)
Alpha subunit levels were determined at a central laboratory.
Time frame: Baseline up to approximately Week 96
Population: Evaluable participants had to have 50% reduction
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pasireotide LAR | Percentage of Participants With Reduction From Baseline of Alpha Subunit ≥50% in Main and Extension Phases (FAS) | 8.3 percentage of participants |
| Week 4 | Percentage of Participants With Reduction From Baseline of Alpha Subunit ≥50% in Main and Extension Phases (FAS) | 28.6 percentage of participants |
| Week 12 | Percentage of Participants With Reduction From Baseline of Alpha Subunit ≥50% in Main and Extension Phases (FAS) | 12.5 percentage of participants |
| Week 24 | Percentage of Participants With Reduction From Baseline of Alpha Subunit ≥50% in Main and Extension Phases (FAS) | 22.2 percentage of participants |
| Week 48 | Percentage of Participants With Reduction From Baseline of Alpha Subunit ≥50% in Main and Extension Phases (FAS) | 0 percentage of participants |
Secondary
Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Time frame: baseline to week 48, 72, 96
Population: number of participants with evaluable data varied across visits
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pasireotide LAR | Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS) | Extension Week 48 | 10.0 percentage of patients |
| Pasireotide LAR | Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS) | Extension Week 72 | 12.5 percentage of patients |
| Pasireotide LAR | Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS) | Extension Week 96 | 50.0 percentage of patients |
Secondary
Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Time frame: baseline to week 4, 12, 24
Population: number of participants with evaluable data varied across visits
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pasireotide LAR | Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS) | Week 4 | 47.4 percentage of patients |
| Pasireotide LAR | Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS) | Week 12 | 41.2 percentage of patients |
| Pasireotide LAR | Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS) | Week 24 | 75.0 percentage of patients |
Secondary
Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Extension Phase (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Time frame: baseline to week 48, 72, 96
Population: number of participants with evaluable data varied across visits
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pasireotide LAR | Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Extension Phase (FAS) | Extension Week 48 | 10.0 percentage of patients |
| Pasireotide LAR | Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Extension Phase (FAS) | Extension Week 72 | 12.5 percentage of patients |
| Pasireotide LAR | Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Extension Phase (FAS) | Extension Week 96 | 50.0 percentage of patients |
Secondary
Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Time frame: baseline to week 4, 12, 24
Population: number of participants with evaluable data varied across visits
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pasireotide LAR | Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS) | Main Week 4 | 10.5 percentage of patients |
| Pasireotide LAR | Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS) | Main Week 12 | 5.9 percentage of patients |
| Pasireotide LAR | Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS) | Main Week 24 | 16.7 percentage of patients |
Secondary
Tumor Volume Change From Baseline in Extension Phase (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Time frame: baseline to week 48, 72, 96
Population: number of participants with evaluable data varied across visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pasireotide LAR | Tumor Volume Change From Baseline in Extension Phase (FAS) | Extension Week 48 | 0.53 cm^3 | Standard Deviation 2.19 |
| Pasireotide LAR | Tumor Volume Change From Baseline in Extension Phase (FAS) | Extension Week 72 | -0.14 cm^3 | Standard Deviation 0.63 |
| Pasireotide LAR | Tumor Volume Change From Baseline in Extension Phase (FAS) | Extension Week 96 | 0.0 cm^3 | Standard Deviation 0.9 |
Secondary
Tumor Volume Change From Baseline in Main Phase (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Time frame: baseline to week 4, 12, 24
Population: number of participants with evaluable data varied across visits
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pasireotide LAR | Tumor Volume Change From Baseline in Main Phase (FAS) | Main Week 4 | 1.25 cm^3 |
| Pasireotide LAR | Tumor Volume Change From Baseline in Main Phase (FAS) | Main Week 12 | 0.66 cm^3 |
| Pasireotide LAR | Tumor Volume Change From Baseline in Main Phase (FAS) | Main Week 24 | 0.23 cm^3 |
Secondary
Tumor Volume in Extension Phase (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Time frame: baseline to week 48, 72, 96
Population: number of participants with evaluable data varied across visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pasireotide LAR | Tumor Volume in Extension Phase (FAS) | Extension Week 48 | 3.57 cm^3 | Standard Deviation 3.25 |
| Pasireotide LAR | Tumor Volume in Extension Phase (FAS) | Extension Week 72 | 3.12 cm^3 | Standard Deviation 2.48 |
| Pasireotide LAR | Tumor Volume in Extension Phase (FAS) | Extension Week 96 | 1.70 cm^3 | Standard Deviation 1.02 |
Secondary
Tumor Volume Main Phase (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Time frame: baseline to week 4, 12, 24
Population: number of participants with evaluable data varied across visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pasireotide LAR | Tumor Volume Main Phase (FAS) | Main Baseline | 2.97 cm^3 | Standard Deviation 2.53 |
| Pasireotide LAR | Tumor Volume Main Phase (FAS) | Main Week 4 | 4.31 cm^3 | Standard Deviation 6.66 |
| Pasireotide LAR | Tumor Volume Main Phase (FAS) | Main Week 12 | 4.31 cm^3 | Standard Deviation 6.66 |
| Pasireotide LAR | Tumor Volume Main Phase (FAS) | Main Week 24 | 3.39 cm^3 | Standard Deviation 3.15 |
Secondary
Tumor Volume Percent Change From Baseline in Extension Phase (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Time frame: baseline to week 48, 72, 96
Population: number of participants with evaluable data varied across visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pasireotide LAR | Tumor Volume Percent Change From Baseline in Extension Phase (FAS) | Extension Week 48 | 14.83 percent change | Standard Deviation 67.28 |
| Pasireotide LAR | Tumor Volume Percent Change From Baseline in Extension Phase (FAS) | Extension Week 72 | -2.57 percent change | Standard Deviation 14.33 |
| Pasireotide LAR | Tumor Volume Percent Change From Baseline in Extension Phase (FAS) | Extension Week 96 | -1.59 percent change | Standard Deviation 53.09 |
Secondary
Tumor Volume Percent Change From Baseline in Main Phase (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Time frame: baseline to week 4, 12, 24
Population: number of participants with evaluable data varied across visits
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pasireotide LAR | Tumor Volume Percent Change From Baseline in Main Phase (FAS) | Main Week 4 | 36.92 percent change |
| Pasireotide LAR | Tumor Volume Percent Change From Baseline in Main Phase (FAS) | Main Week 12 | 39.36 percent change |
| Pasireotide LAR | Tumor Volume Percent Change From Baseline in Main Phase (FAS) | Main Week 24 | 7.98 percent change |