| 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. | Evaluable participants required tumor volume assessment at baseline and at week 24 | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline up to 24 weeks | | | | ID | Title | Description |
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| OG000 | Pasireotide LAR | All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks |
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| 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. | number of participants with evaluable data varied across visits | Posted | | Mean | Standard Deviation | cm^3 | | baseline to week 4, 12, 24 | | | | ID | Title | Description |
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| OG000 | Pasireotide LAR | All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks |
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| 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. | number of participants with evaluable data varied across visits | Posted | | Mean | Standard Deviation | cm^3 | | baseline to week 48, 72, 96 | | | | ID | Title | Description |
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| OG000 | Pasireotide LAR | All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks |
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| 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. | number of participants with evaluable data varied across visits | Posted | | Mean | 95% Confidence Interval | cm^3 | | baseline to week 4, 12, 24 | | | | ID | Title | Description |
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| OG000 | Pasireotide LAR | All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks |
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| 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. | number of participants with evaluable data varied across visits | Posted | | Mean | Standard Deviation | cm^3 | | baseline to week 48, 72, 96 | | | | ID | Title | Description |
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| OG000 | Pasireotide LAR | All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks |
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| 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. | number of participants with evaluable data varied across visits | Posted | | Mean | 95% Confidence Interval | percent change | | baseline to week 4, 12, 24 | | | | ID | Title | Description |
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| OG000 | Pasireotide LAR | All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks |
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| 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. | number of participants with evaluable data varied across visits | Posted | | Mean | Standard Deviation | percent change | | baseline to week 48, 72, 96 | | | | ID | Title | Description |
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| OG000 | Pasireotide LAR | All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks |
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| 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. | number of participants with evaluable data varied across visits | Posted | | Number | | percentage of patients | | baseline to week 4, 12, 24 | | | | ID | Title | Description |
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| OG000 | Pasireotide LAR | All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks |
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| 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. | number of participants with evaluable data varied across visits | Posted | | Number | 95% Confidence Interval | percentage of patients | | baseline to week 4, 12, 24 | | | | ID | Title | Description |
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| OG000 | Pasireotide LAR | All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks |
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| 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. | number of participants with evaluable data varied across visits | Posted | | Number | | percentage of patients | | baseline to week 48, 72, 96 | | | | ID | Title | Description |
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| OG000 | Pasireotide LAR | All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks |
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| 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. | number of participants with evaluable data varied across visits | Posted | | Number | | percentage of patients | | baseline to week 48, 72, 96 | | | | ID | Title | Description |
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| OG000 | Pasireotide LAR | All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks |
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| 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 | number of participants varied across visits | Posted | | Number | | percentage of participants | | Baseline and at weeks 4, 12,24,48,72, 96 | | | | ID | Title | Description |
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| OG000 | Baseline | | | OG001 | Week 4 | | | OG002 | Week 12 | | | OG003 | Week 24 | | | OG004 | Week 48 | Week 48 of Extension Phase |
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| 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 | number of participants with evaluable data varied across visits | Posted | | Mean | Standard Deviation | ng/mL | | Baseline and at weeks 24, 48, 96 | | | | ID | Title | Description |
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| OG000 | Baseline | | | OG001 | Week 24 | | | OG002 | Week 48 | Week 48 of Extension Phase | | OG003 | Week 96 | Week 96 of Extension Phase |
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| 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 | participants with evaluable data varied across visits | Posted | | Mean | Standard Deviation | pg/mL | | Baseline and at weeks 24, 48, 96 | | | | ID | Title | Description |
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| OG000 | Baseline | | | OG001 | Week 24 | | | OG002 | Week 48 | Week 48 of Extension Phase | | OG003 | Week 96 | Week 96 of Extension Phase |
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| 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 | number participants with evaluable data varied across visits | Posted | | Mean | Standard Deviation | µg/dL | | Baseline and at weeks 24, 48, 96 | | | | ID | Title | Description |
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| OG000 | Baseline | | | OG001 | Week 24 | | | OG002 | Week 48 | Week 48 of Extension Phase | | OG003 | Week 96 | Week 96 of Extension Phase |
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| 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 | participants with evaluable data varied across visits | Posted | | Mean | Standard Deviation | mUI/mL | | Baseline and at weeks 24, 48, 96 | | | | ID | Title | Description |
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| OG000 | Baseline | | | OG001 | Week 24 | | | OG002 | Week 48 | Week 48 of Extension Phase | | OG003 | Week 96 | Week 96 of Extension Phase |
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| 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 | participants with evaluable data varied across visits | Posted | | Mean | Standard Deviation | ng/dL | | Baseline and at weeks 24, 48, 96 | | | | ID | Title | Description |
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| OG000 | Baseline | | | OG001 | Week 24 | | | OG002 | Week 48 | Week 48 of Extension Phase | | OG003 | Week 96 | Week 96 of Extension Phase |
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| 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 | participants with evaluable data varied across visits | Posted | | Mean | Standard Deviation | µUI/mL | | Baseline and at weeks 24, 48, 96 | | | | ID | Title | Description |
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| OG000 | Baseline | | | OG001 | Week 24 | | | OG002 | Week 48 | Week 48 of Extension Phase | | OG003 | Week 96 | Week 96 of Extension Phase |
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| Secondary | Mean Alpha Subunit Levels in Main and Extension Phases (FAS) | | | Posted | | Mean | Standard Deviation | ng/mL | | Baseline and at weeks 12,24,48,72, 96 | | | | ID | Title | Description |
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| OG000 | Baseline | | | OG001 | Week 12 | | | OG002 | Week 24 | | | OG003 | Week 48 | Week 48 of Extension Phase | | OG004 | Week 72 | Week 72 of Extension Phase | | OG005 | Week 96 | Week 96 of Extension Phase |
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| 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. | Evaluable participants had to have 50% reduction | Posted | | Number | | percentage of participants | | Baseline up to approximately Week 96 | | | | ID | Title | Description |
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| OG000 | Week 12 | | | OG001 | Week 24 | | | OG002 | Week 48 | Week 48 of Extension Phase | | OG003 | Week 72 | Week 72 of Extension Phase | | OG004 | Week 96 | Week 96 of Extension Phase |
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