Acromegaly, Pituitary Gigantism
Conditions
Keywords
SOM230, Pasireotide, acromegaly, Phase II, growth disorder, gigantism, Pituitary adenoma, pituitary gigantism
Brief summary
To evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of pasireotide LAR in Japanese patients with active acromegaly or pituitary gigantism. Primary objective was to assess the total-group efficacy of pasireotide LAR on the reduction of mean GH levels to \< 2.5 µg/L and the normalization of insulin-like growth factor-1 (IGF-1) at 3 months of study treatment.
Interventions
DRUGPasireotide LAR
Intramuscular administration of pasireotide LAR was repeated every month (1 month = 28 days) for 12 months in core phase. It was permitted to increase the dose up to 60 mg in a patient showing the following biochemical test results after 3 and 6 months of study treatment: mean GH levels ≥2.5 µg/L and/or IGF-1 \> ULN. In the event of any problem with tolerability, it was permitted to reduce the next lower dosage level at any time.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with medication naïve acromegaly or pituitary gigantism * Patients with inadequately controlled acromegaly or pituitary gigantism
Exclusion criteria
* Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1c \>8% * Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment * Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF \> 470 ms, hypokalemia, hypomagnesemia, hypocalcemia, family history of long QT syndrome, or patients receiving a concomitant medication known to prolong QT interval
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total-group Response Rate at Month 3 | Month 3 | Percentage of participants with a reduction of mean growth hormone (GH) levels to \< 2.5 µg/L and the normalization of insulin-like growth factor-1 (IGF-1) to within normal limits (age and sex related) at 3 months across all doses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GH Response at Month 3 by Randomized Dose | Month 3 | Percentage of participants with a reduction of mean GH levels to \< 2.5 µg/L at 3 months. |
| IGF-1 Response at Month 3 by Randomized Dose | Month 3 | Percentage of participants with the normalization of IGF-1 to within normal limits (age and sex related) at 3 months. |
| Total-group Response Rate (GH & IGF-1) Over Time (Core Phase) | Months 3, 6, 9 & 12 | Percentage of participants with a reduction of mean GH levels to \< 2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) at 3, 6, 9 and 12 months |
| Percentage of Overall Participants With the Reduction of GH Levels to <2.5 ug/L by Visit (Core Phase) | Months 3, 6, 9, 12 | This refers to the percentage of participants with a reduction of growth hormone (GH) response rates to \<2.5 ug/L over time. |
| Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Core Phase) | Months 3, 6, 9, 12 | This refers to the percentage of participants with the normalization of insulin-like growth factor-1 (IGF-1) to within normal limits by visit. |
| Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level | Ctrough: Day 28 after each injection 1-3, Cmax: 3 months after injections 1 and 3 | Ctrough: The trough level concentration on day 28, 3 months post 1st, 2nd and 3rd injections of Pasireotide LAR. Cmax: The maximum concentration 3 months post the 1st injection and 3rd injection of LAR. |
| Summary of Pasireotide LAR PK Parameter of Accumulation Ratio Randomized Dose Level | Day 28 after injections 1 and 3 | The accumulation ratio was calculated as a ratio of (Ctrough day28, 3rd injection/Ctrough day28, 1st injection). |
| Change of Tumor Volume From Baseline | Baseline, Months 6 , 12 | This shows the change in tumor volume from baseline to month 6 and from baseline to month 12 in patients treated with pasireotide LAR. |
| Response Rate at Month 3 by Randomized Dose Level | Month 3 | Percentage of participants with a reduction of mean GH levels to \< 2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) at 3 months in each starting dose. |
| Percentage of Overall Participants With the Reduction of Mean GH Levels to <2.5 ug/L by Visit (Extension Phase) | Months 18, 24 | Percentage of participants with a reduction of mean GH levels to \< 2.5µg/L at 18 and 24 months of study treatment |
| Change in Mean GH Levels From Baseline | Baseline, Months 2.75, 3, 6, 9, 12, 18, 24 | This shows the change in mean GH levels from baseline in median GH levels by visit. |
| Change in Ring Size From Baseline | Baseline, Months 3, 6, 9, 12 | Change of clinical signs from baseline: ring size. In Japan, ring sizes are specified using a numerical scale, that only has whole sizes, and does not have simple linear correlation with diameter or circumference. Only numbers are used ranging from 1 to 27. For instance, a ring size of 1 in Japan is equivalent to an inside circumference ring size of 38.86 mm and a ring size of 27 in Japan is equivalent to an inside circumference ring size of 70.15 mm. |
| Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | 12 Months (Core phase) | Number of participants with a change of clinical signs from baseline (BL): headache (HA), fatigue (FA), perspiration (PE), paresthesias (PA), osteoarthralgia (OS) |
| Change From Baseline in Prolactin | Baseline, Months 3, 6, 9, 12 | Change in prolactin levels from baseline |
| Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Extension Phase) | Months 18, 24 | Percentage of participants with the normalization of IGF-1 to within normal limits (age and sex related) at 18 and 24 months of study. treatment |
| Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase) | Baselnine, Months 2.75, 3, 6, 9, 12, 18, 24 | This shows a change of mean GH levels and somatostatin analogues (SSAs) from baseline in extension phase |
| Total-group Response Rate by Visit (Extension Phase) | Months 18, 24 | Percentage of participants with a reduction of mean GH levels to \< 2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) a18 and 24 months of study treatment. |
Countries
Japan
Participant flow
Recruitment details
30 patients were planned and 33 patients were enrolled. The full analysis sets (FAS) consisted of 33 patients (11 patients per dose group).
Participants by arm
| Arm | Count |
|---|---|
| Pasireotide LAR 20mg Enrolled patients were randomized to 20mg pasireotide LAR. | 11 |
| Pasireotide LAR 40mg Enrolled patients were randomized to 40mg pasireotide LAR. | 11 |
| Pasireotide LAR 60mg Enrolled patients were randomized to 60mg pasireotide LAR. | 11 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 1 |
| Overall Study | Completed Core/did not enter Ext. | 2 | 1 | 1 |
| Overall Study | Condition no longer requires study drug | 0 | 1 | 0 |
| Overall Study | Unsatisfactory therapeutic effect | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 2 |
Baseline characteristics
| Characteristic | Pasireotide LAR 20mg | Pasireotide LAR 40mg | Pasireotide LAR 60mg | Total |
|---|---|---|---|---|
| Age, Continuous | 57.2 Years STANDARD_DEVIATION 11.48 | 49.1 Years STANDARD_DEVIATION 13.75 | 46.6 Years STANDARD_DEVIATION 14.6 | 51.0 Years STANDARD_DEVIATION 13.71 |
| Race/Ethnicity, Customized Asian | 11 Participants | 11 Participants | 11 Participants | 33 Participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 2 Participants | 13 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 9 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 33 |
| other Total, other adverse events | 11 / 11 | 11 / 11 | 11 / 11 | 33 / 33 |
| serious Total, serious adverse events | 3 / 11 | 3 / 11 | 5 / 11 | 11 / 33 |
Outcome results
Primary
Total-group Response Rate at Month 3
Percentage of participants with a reduction of mean growth hormone (GH) levels to \< 2.5 µg/L and the normalization of insulin-like growth factor-1 (IGF-1) to within normal limits (age and sex related) at 3 months across all doses
Time frame: Month 3
Population: The Full analysis Set (FAS): Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pasireotide LAR - All Participants | Total-group Response Rate at Month 3 | 18.2 Percentage of participants |
Secondary
Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase)
This shows a change of mean GH levels and somatostatin analogues (SSAs) from baseline in extension phase
Time frame: Baselnine, Months 2.75, 3, 6, 9, 12, 18, 24
Population: FAS: Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pasireotide LAR - All Participants | Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase) | Month 6 | -8.15 ug/L |
| Pasireotide LAR - All Participants | Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase) | Month 12 | -10.10 ug/L |
| Pasireotide LAR - All Participants | Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase) | Month 3 | -6.71 ug/L |
| Pasireotide LAR - All Participants | Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase) | Month 18 | -8.88 ug/L |
| Pasireotide LAR - All Participants | Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase) | Month 9 | -9.02 ug/L |
| Pasireotide LAR - All Participants | Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase) | Month 24 | -9.76 ug/L |
| Pasireotide LAR - All Participants | Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase) | Month 2.75 | -8.84 ug/L |
| Pasireotide LAR 40mg | Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase) | Month 24 | -6.80 ug/L |
| Pasireotide LAR 40mg | Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase) | Month 2.75 | -6.62 ug/L |
| Pasireotide LAR 40mg | Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase) | Month 3 | -5.04 ug/L |
| Pasireotide LAR 40mg | Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase) | Month 6 | -6.35 ug/L |
| Pasireotide LAR 40mg | Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase) | Month 9 | -8.72 ug/L |
| Pasireotide LAR 40mg | Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase) | Month 12 | -7.29 ug/L |
| Pasireotide LAR 40mg | Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase) | Month 18 | -7.70 ug/L |
Secondary
Change From Baseline in Prolactin
Change in prolactin levels from baseline
Time frame: Baseline, Months 3, 6, 9, 12
Population: FAS: Comprises all patients to whom study treatment has been assigned by randomization. Protocol allowed to change treatment dose (eg, 20mg -\> 40mg -\>20mg -\> 40mg -\>60mg) based on efficacy and safety after 3month treatment. So we combined Arms/groups.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pasireotide LAR - All Participants | Change From Baseline in Prolactin | Month 3 | -43.00 pmol/L |
| Pasireotide LAR - All Participants | Change From Baseline in Prolactin | Month 6 | 0.00 pmol/L |
| Pasireotide LAR - All Participants | Change From Baseline in Prolactin | Month 9 | 0.00 pmol/L |
| Pasireotide LAR - All Participants | Change From Baseline in Prolactin | Month 12 | 0.00 pmol/L |
Secondary
Change in Mean GH Levels From Baseline
This shows the change in mean GH levels from baseline in median GH levels by visit.
Time frame: Baseline, Months 2.75, 3, 6, 9, 12, 18, 24
Population: FAS: Comprises all patients to whom study treatment has been assigned by randomization. Protocol allowed to change treatment dose (eg, 20mg -\> 40mg -\>20mg -\> 40mg -\>60mg) based on efficacy and safety after 3month treatment. So we combined Arms/groups.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pasireotide LAR - All Participants | Change in Mean GH Levels From Baseline | Change from baseline @ Month 6 | -7.27 ug/L |
| Pasireotide LAR - All Participants | Change in Mean GH Levels From Baseline | Change from baseline @ Month 2.75 | -7.60 ug/L |
| Pasireotide LAR - All Participants | Change in Mean GH Levels From Baseline | Change from baseline @ Month 3 | -5.98 ug/L |
| Pasireotide LAR - All Participants | Change in Mean GH Levels From Baseline | Change from baseline @ Month 9 | -8.83 ug/L |
| Pasireotide LAR - All Participants | Change in Mean GH Levels From Baseline | Change from baseline @ Month 12 | -8.90 ug/L |
| Pasireotide LAR - All Participants | Change in Mean GH Levels From Baseline | Change from baseline @ Month 18 | -15.68 ug/L |
| Pasireotide LAR - All Participants | Change in Mean GH Levels From Baseline | Change from baseline @ Month 24 | -16.67 ug/L |
Secondary
Change in Ring Size From Baseline
Change of clinical signs from baseline: ring size. In Japan, ring sizes are specified using a numerical scale, that only has whole sizes, and does not have simple linear correlation with diameter or circumference. Only numbers are used ranging from 1 to 27. For instance, a ring size of 1 in Japan is equivalent to an inside circumference ring size of 38.86 mm and a ring size of 27 in Japan is equivalent to an inside circumference ring size of 70.15 mm.
Time frame: Baseline, Months 3, 6, 9, 12
Population: FAS: Comprises all patients to whom study treatment has been assigned by randomization. Protocol allowed to change treatment dose (eg, 20mg -\> 40mg -\>20mg -\> 40mg -\>60mg) based on efficacy and safety after 3month treatment. So we combined Arms/groups.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pasireotide LAR - All Participants | Change in Ring Size From Baseline | Month 3 | -1.00 other - Japanese ring size number |
| Pasireotide LAR - All Participants | Change in Ring Size From Baseline | Month 6 | -2.00 other - Japanese ring size number |
| Pasireotide LAR - All Participants | Change in Ring Size From Baseline | Month 9 | -2.00 other - Japanese ring size number |
| Pasireotide LAR - All Participants | Change in Ring Size From Baseline | Month 12 | -2.00 other - Japanese ring size number |
Secondary
Change of Tumor Volume From Baseline
This shows the change in tumor volume from baseline to month 6 and from baseline to month 12 in patients treated with pasireotide LAR.
Time frame: Baseline, Months 6 , 12
Population: FAS: Comprises all patients to whom study treatment has been assigned by randomization. Protocol allowed to change treatment dose (eg, 20mg -\> 40mg -\>20mg -\> 40mg -\>60mg) based on efficacy and safety after 3month treatment. So we combined Arms/groups.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pasireotide LAR - All Participants | Change of Tumor Volume From Baseline | Change from baseline @ Month 6 | -21.0 mm^3 |
| Pasireotide LAR - All Participants | Change of Tumor Volume From Baseline | Change from baseline @ Month 12 | -1.00 mm^3 |
Secondary
GH Response at Month 3 by Randomized Dose
Percentage of participants with a reduction of mean GH levels to \< 2.5 µg/L at 3 months.
Time frame: Month 3
Population: FAS: Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pasireotide LAR - All Participants | GH Response at Month 3 by Randomized Dose | 27.3 Percentage of participants |
| Pasireotide LAR 40mg | GH Response at Month 3 by Randomized Dose | 45.5 Percentage of participants |
| Pasireotide LAR 60mg | GH Response at Month 3 by Randomized Dose | 18.2 Percentage of participants |
Secondary
IGF-1 Response at Month 3 by Randomized Dose
Percentage of participants with the normalization of IGF-1 to within normal limits (age and sex related) at 3 months.
Time frame: Month 3
Population: FAS: Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pasireotide LAR - All Participants | IGF-1 Response at Month 3 by Randomized Dose | 18.2 Percentage of participants |
| Pasireotide LAR 40mg | IGF-1 Response at Month 3 by Randomized Dose | 45.5 Percentage of participants |
| Pasireotide LAR 60mg | IGF-1 Response at Month 3 by Randomized Dose | 9.1 Percentage of participants |
Secondary
Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase)
Number of participants with a change of clinical signs from baseline (BL): headache (HA), fatigue (FA), perspiration (PE), paresthesias (PA), osteoarthralgia (OS)
Time frame: 12 Months (Core phase)
Population: Full analysis set (FAS) comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ most extreme post-BL: total severe | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ most extreme post-BL: total very severe | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ BL: moderate | 1 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ BL: total (all categories) | 11 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ most extreme post-BL: total severe | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ BL: severe | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ BL: mild | 1 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ most extreme post-BL: total moderate | 1 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ BL: very severe | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ most extreme post-BL: total moderate | 2 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ most extreme post-BL: total mild | 5 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ BL: total (all categories) | 11 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ BL: very severe | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ most extreme post-BL: total non/absent | 5 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ most extreme post-BL: total non/absent | 4 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ BL: moderate | 1 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ BL: total (all categories) | 11 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ most extreme post-BL: total mild | 4 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ most extreme post-BL: total non/absent | 8 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ BL: very severe | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ most extreme post-BL: total moderate | 3 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ BL: severe | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ BL: severe | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ most extreme post-BL: total severe | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ BL: severe | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ BL: moderate | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ most extreme post-BL: total very severe | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ most extreme post-BL: total moderate | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ BL: mild | 5 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ most extreme post-BL: total (all categories) | 11 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ BL: moderate | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ BL: non/absent | 6 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ BL: very severe | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ most extreme post-BL: total severe | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ BL: mild | 2 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ BL: total (all categories) | 11 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ most extreme post-BL: total very severe | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ BL: non/absent | 9 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ most extreme post-BL: total non/absent | 8 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ most extreme post-BL: total mild | 4 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ BL: very severe | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ most extreme post-BL: total mild | 3 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ most extreme post-BL: total very severe | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ BL: severe | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ most extreme post-BL: total moderate | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ most extreme post-BL: total mild | 1 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ BL: total (all categories) | 11 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ most extreme post-BL: total severe | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ most extreme post-BL: total non/absent | 7 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ BL: moderate | 1 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ most extreme post-BL: total very severe | 0 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ most extreme post-BL: total (all categories) | 11 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ BL: mild | 1 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ most extreme post-BL: total (all categories) | 11 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ most extreme post-BL: total (all categories) | 11 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ BL: non/absent | 9 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ BL: non/absent | 7 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ BL: non/absent | 9 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ most extreme post-BL: total (all categories) | 11 Participants |
| Pasireotide LAR - All Participants | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ BL: mild | 3 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ BL: moderate | 2 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ most extreme post-BL: total non/absent | 5 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ BL: total (all categories) | 11 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ most extreme post-BL: total mild | 2 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ most extreme post-BL: total moderate | 2 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ most extreme post-BL: total severe | 1 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ most extreme post-BL: total very severe | 1 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ most extreme post-BL: total (all categories) | 11 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ BL: non/absent | 6 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ BL: mild | 4 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ BL: moderate | 0 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ BL: severe | 0 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ BL: very severe | 1 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ BL: total (all categories) | 11 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ most extreme post-BL: total non/absent | 8 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ most extreme post-BL: total mild | 2 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ most extreme post-BL: total moderate | 0 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ most extreme post-BL: total severe | 1 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ most extreme post-BL: total very severe | 0 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ most extreme post-BL: total (all categories) | 11 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ BL: non/absent | 5 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ BL: mild | 3 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ BL: moderate | 2 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ BL: severe | 1 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ BL: very severe | 0 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ BL: total (all categories) | 11 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ most extreme post-BL: total non/absent | 3 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ most extreme post-BL: total mild | 5 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ most extreme post-BL: total moderate | 3 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ most extreme post-BL: total severe | 0 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ most extreme post-BL: total very severe | 0 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ most extreme post-BL: total (all categories) | 11 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ BL: non/absent | 6 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ BL: mild | 3 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ BL: moderate | 2 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ BL: severe | 0 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ BL: very severe | 0 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ BL: total (all categories) | 11 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ most extreme post-BL: total non/absent | 7 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ most extreme post-BL: total mild | 2 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ most extreme post-BL: total moderate | 1 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ most extreme post-BL: total severe | 1 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ most extreme post-BL: total very severe | 0 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ most extreme post-BL: total (all categories) | 11 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ BL: non/absent | 5 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ BL: mild | 1 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ BL: severe | 2 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ BL: very severe | 1 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ BL: non/absent | 11 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ BL: mild | 0 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ BL: moderate | 0 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ BL: severe | 0 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ BL: very severe | 0 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ BL: total (all categories) | 11 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ most extreme post-BL: total non/absent | 9 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ most extreme post-BL: total mild | 1 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ most extreme post-BL: total moderate | 1 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ most extreme post-BL: total severe | 0 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ most extreme post-BL: total very severe | 0 Participants |
| Pasireotide LAR 40mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ most extreme post-BL: total (all categories) | 11 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ BL: total (all categories) | 11 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ most extreme post-BL: total severe | 1 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ BL: mild | 2 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ most extreme post-BL: total very severe | 0 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ most extreme post-BL: total very severe | 0 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ BL: non/absent | 6 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ most extreme post-BL: total non/absent | 6 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ most extreme post-BL: total (all categories) | 11 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ most extreme post-BL: total (all categories) | 11 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ most extreme post-BL: total non/absent | 9 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ BL: non/absent | 7 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ most extreme post-BL: total very severe | 0 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ most extreme post-BL: total severe | 1 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ BL: mild | 3 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ most extreme post-BL: total severe | 0 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ most extreme post-BL: total moderate | 1 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ BL: moderate | 1 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ most extreme post-BL: total mild | 3 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ most extreme post-BL: total (all categories) | 11 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ BL: severe | 0 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ most extreme post-BL: total non/absent | 7 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ most extreme post-BL: total mild | 1 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ BL: very severe | 0 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ most extreme post-BL: total (all categories) | 11 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ BL: total (all categories) | 11 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ most extreme post-BL: total moderate | 1 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ BL: non/absent | 9 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ BL: very severe | 0 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ most extreme post-BL: total very severe | 0 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ BL: mild | 1 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ BL: severe | 1 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ most extreme post-BL: total moderate | 1 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ most extreme post-BL: total (all categories) | 11 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ BL: moderate | 1 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ BL: non/absent | 3 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ most extreme post-BL: total very severe | 0 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ BL: moderate | 0 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ BL: mild | 6 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ most extreme post-BL: total severe | 1 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ most extreme post-BL: total mild | 3 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ BL: moderate | 2 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ most extreme post-BL: total moderate | 1 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ BL: severe | 0 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ BL: severe | 0 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ most extreme post-BL: total mild | 4 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ BL: mild | 0 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ BL: very severe | 0 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ most extreme post-BL: total non/absent | 5 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | OS @ BL: total (all categories) | 11 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ BL: total (all categories) | 11 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ BL: total (all categories) | 11 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ BL: very severe | 0 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ most extreme post-BL: total non/absent | 7 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ BL: very severe | 0 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | HA @ BL: non/absent | 10 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ most extreme post-BL: total mild | 3 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ BL: severe | 0 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PA @ most extreme post-BL: total severe | 0 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | PE @ most extreme post-BL: total moderate | 0 Participants |
| Pasireotide LAR 60mg | Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) | FA @ BL: moderate | 3 Participants |
Secondary
Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Core Phase)
This refers to the percentage of participants with the normalization of insulin-like growth factor-1 (IGF-1) to within normal limits by visit.
Time frame: Months 3, 6, 9, 12
Population: FAS: Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pasireotide LAR - All Participants | Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Core Phase) | Month 3 | 24.2 Percentage of participants |
| Pasireotide LAR - All Participants | Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Core Phase) | Month 6 | 33.3 Percentage of participants |
| Pasireotide LAR - All Participants | Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Core Phase) | Month 9 | 39.4 Percentage of participants |
| Pasireotide LAR - All Participants | Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Core Phase) | Month 12 | 27.3 Percentage of participants |
Secondary
Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Extension Phase)
Percentage of participants with the normalization of IGF-1 to within normal limits (age and sex related) at 18 and 24 months of study. treatment
Time frame: Months 18, 24
Population: FAS: Comprises all patients to whom study treatment has been assigned by randomization. The protocol allowed frequent dose changes even extension phase. In this case, separate data is not meaningful.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pasireotide LAR - All Participants | Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Extension Phase) | Month 18 | 16.7 Percentage of participants |
| Pasireotide LAR - All Participants | Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Extension Phase) | Month 24 | 30.4 Percentage of participants |
Secondary
Percentage of Overall Participants With the Reduction of GH Levels to <2.5 ug/L by Visit (Core Phase)
This refers to the percentage of participants with a reduction of growth hormone (GH) response rates to \<2.5 ug/L over time.
Time frame: Months 3, 6, 9, 12
Population: FAS: Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pasireotide LAR - All Participants | Percentage of Overall Participants With the Reduction of GH Levels to <2.5 ug/L by Visit (Core Phase) | Month 3 | 30.3 Percenage of participants |
| Pasireotide LAR - All Participants | Percentage of Overall Participants With the Reduction of GH Levels to <2.5 ug/L by Visit (Core Phase) | Month 6 | 33.3 Percenage of participants |
| Pasireotide LAR - All Participants | Percentage of Overall Participants With the Reduction of GH Levels to <2.5 ug/L by Visit (Core Phase) | Month 9 | 30.3 Percenage of participants |
| Pasireotide LAR - All Participants | Percentage of Overall Participants With the Reduction of GH Levels to <2.5 ug/L by Visit (Core Phase) | Month 12 | 36.4 Percenage of participants |
Secondary
Percentage of Overall Participants With the Reduction of Mean GH Levels to <2.5 ug/L by Visit (Extension Phase)
Percentage of participants with a reduction of mean GH levels to \< 2.5µg/L at 18 and 24 months of study treatment
Time frame: Months 18, 24
Population: FAS: Comprises all patients to whom study treatment has been assigned by randomization. The protocol allowed frequent dose changes even extension phase. In this case, separate data is not meaningful.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pasireotide LAR - All Participants | Percentage of Overall Participants With the Reduction of Mean GH Levels to <2.5 ug/L by Visit (Extension Phase) | Month 18 | 41.7 Percentage of participants |
| Pasireotide LAR - All Participants | Percentage of Overall Participants With the Reduction of Mean GH Levels to <2.5 ug/L by Visit (Extension Phase) | Month 24 | 60.9 Percentage of participants |
Secondary
Response Rate at Month 3 by Randomized Dose Level
Percentage of participants with a reduction of mean GH levels to \< 2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) at 3 months in each starting dose.
Time frame: Month 3
Population: FAS: Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pasireotide LAR - All Participants | Response Rate at Month 3 by Randomized Dose Level | 9.1 Percentage of participants |
| Pasireotide LAR 40mg | Response Rate at Month 3 by Randomized Dose Level | 36.4 Percentage of participants |
| Pasireotide LAR 60mg | Response Rate at Month 3 by Randomized Dose Level | 9.1 Percentage of participants |
Secondary
Summary of Pasireotide LAR PK Parameter of Accumulation Ratio Randomized Dose Level
The accumulation ratio was calculated as a ratio of (Ctrough day28, 3rd injection/Ctrough day28, 1st injection).
Time frame: Day 28 after injections 1 and 3
Population: PAS: Consists of full analysis set (FAS) who have evaluable PK concentration data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pasireotide LAR - All Participants | Summary of Pasireotide LAR PK Parameter of Accumulation Ratio Randomized Dose Level | 1.33 ratio | Standard Deviation 0.53 |
| Pasireotide LAR 40mg | Summary of Pasireotide LAR PK Parameter of Accumulation Ratio Randomized Dose Level | 1.85 ratio | Standard Deviation 1.17 |
| Pasireotide LAR 60mg | Summary of Pasireotide LAR PK Parameter of Accumulation Ratio Randomized Dose Level | 1.64 ratio | Standard Deviation 1.41 |
Secondary
Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level
Ctrough: The trough level concentration on day 28, 3 months post 1st, 2nd and 3rd injections of Pasireotide LAR. Cmax: The maximum concentration 3 months post the 1st injection and 3rd injection of LAR.
Time frame: Ctrough: Day 28 after each injection 1-3, Cmax: 3 months after injections 1 and 3
Population: The pharmacokinetic (PK) analysis set (PAS) consists of full analysis set (FAS) who have evaluable PK concentration data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pasireotide LAR - All Participants | Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level | Cmax, 1st inj | 7.19 ng/mL | Standard Deviation 3.48 |
| Pasireotide LAR - All Participants | Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level | Ctrough Day 28, 3rd inj | 5.85 ng/mL | Standard Deviation 2.28 |
| Pasireotide LAR - All Participants | Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level | Ctrough Day 28, 1st inj | 5.36 ng/mL | Standard Deviation 3.35 |
| Pasireotide LAR - All Participants | Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level | Ctrough Day 28, 2nd inj | 5.86 ng/mL | Standard Deviation 2.38 |
| Pasireotide LAR - All Participants | Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level | Cmax, 3rd inj | 8.23 ng/mL | Standard Deviation 2.35 |
| Pasireotide LAR 40mg | Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level | Ctrough Day 28, 3rd inj | 12.2 ng/mL | Standard Deviation 6.75 |
| Pasireotide LAR 40mg | Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level | Ctrough Day 28, 1st inj | 8.41 ng/mL | Standard Deviation 5.26 |
| Pasireotide LAR 40mg | Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level | Ctrough Day 28, 2nd inj | 10.7 ng/mL | Standard Deviation 4.14 |
| Pasireotide LAR 40mg | Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level | Cmax, 1st inj | 10.3 ng/mL | Standard Deviation 7.25 |
| Pasireotide LAR 40mg | Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level | Cmax, 3rd inj | 17.3 ng/mL | Standard Deviation 9.61 |
| Pasireotide LAR 60mg | Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level | Cmax, 3rd inj | 16.2 ng/mL | Standard Deviation 7.12 |
| Pasireotide LAR 60mg | Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level | Cmax, 1st inj | 17.0 ng/mL | Standard Deviation 13.7 |
| Pasireotide LAR 60mg | Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level | Ctrough Day 28, 1st inj | 10.8 ng/mL | Standard Deviation 5.12 |
| Pasireotide LAR 60mg | Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level | Ctrough Day 28, 3rd inj | 11.1 ng/mL | Standard Deviation 4.99 |
| Pasireotide LAR 60mg | Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level | Ctrough Day 28, 2nd inj | 15.0 ng/mL | Standard Deviation 9.12 |
Secondary
Total-group Response Rate by Visit (Extension Phase)
Percentage of participants with a reduction of mean GH levels to \< 2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) a18 and 24 months of study treatment.
Time frame: Months 18, 24
Population: FAS: Comprises all patients to whom study treatment has been assigned by randomization. The protocol allowed frequent dose changes even extension phase. In this case, separate data is not meaningful.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pasireotide LAR - All Participants | Total-group Response Rate by Visit (Extension Phase) | Month 18 | 12.5 Percentage of participants |
| Pasireotide LAR - All Participants | Total-group Response Rate by Visit (Extension Phase) | Month 24 | 30.4 Percentage of participants |
Secondary
Total-group Response Rate (GH & IGF-1) Over Time (Core Phase)
Percentage of participants with a reduction of mean GH levels to \< 2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) at 3, 6, 9 and 12 months
Time frame: Months 3, 6, 9 & 12
Population: FAS: Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pasireotide LAR - All Participants | Total-group Response Rate (GH & IGF-1) Over Time (Core Phase) | Month 3 | 18.2 Percentage of participants |
| Pasireotide LAR - All Participants | Total-group Response Rate (GH & IGF-1) Over Time (Core Phase) | Month 6 | 21.2 Percentage of participants |
| Pasireotide LAR - All Participants | Total-group Response Rate (GH & IGF-1) Over Time (Core Phase) | Month 9 | 21.2 Percentage of participants |
| Pasireotide LAR - All Participants | Total-group Response Rate (GH & IGF-1) Over Time (Core Phase) | Month 12 | 15.2 Percentage of participants |