Safety and Efficacy of Pasireotide Long Acting Release (L... | NCT00600886 | Trialant
NCT00600886
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Jul 2, 2017Actual
Enrollment
358Actual
Phase
Phase 3
Conditions
Acromegaly
Interventions
Pasireotide
Octreotide
Countries
United States
Argentina
Belgium
Brazil
Canada
China
Colombia
Czechia
Denmark
France
Germany
Greece
Hungary
Israel
Italy
Mexico
Netherlands
Norway
Poland
Russia
South Korea
Spain
Sweden
Switzerland
Taiwan
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00600886
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CSOM230C2305
Secondary IDs
ID
Type
Description
Link
2007-001972-36
EudraCT Number
Brief Title
Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly
Official Title
A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jun 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 11, 2008Actual
Primary Completion Date
Mar 11, 2016Actual
Completion Date
Mar 11, 2016Actual
First Submitted Date
Jan 14, 2008
First Submission Date that Met QC Criteria
Jan 24, 2008
First Posted Date
Jan 25, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 19, 2014
Results First Submitted that Met QC Criteria
Jan 28, 2015
Results First Posted Date
Jan 30, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 4, 2014
Certification/Extension First Submitted that Passed QC Review
Nov 4, 2014
Certification/Extension First Posted Date
Nov 18, 2014Estimated
Last Update Submitted Date
Jun 5, 2017
Last Update Posted Date
Jul 2, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment.
The objective of this study was to compare the proportion of patients with a reduction of mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months.
Following one year of treatment patients could proceed into the study extension.
Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) were switched to the other treatment arm at month 13.
Detailed Description
Not provided
Conditions Module
Conditions
Acromegaly
Keywords
Acromegaly,
adult,
growth hormone,
insulin-like growth factor I,
somatostatin analogue
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
358Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Pasireotide LAR
Experimental
Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension.
Drug: Pasireotide
Octreotide LAR
Active Comparator
Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension.
Drug: Octreotide
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pasireotide
Drug
Pasireotide LAR - intramuscular (i.m.) depot injection given once every 28 days.
Pasireotide LAR
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1
Percentage of participants with a reduction of mean GH levels to <2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1.
Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.
12 months
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L
Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile).
Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Patients with active acromegaly (based on elevated GH and IGF-1 levels)
Patients who have undergone one or more pituitary surgeries, but have not been treated medically, or de-novo patients presenting a visible pituitary adenoma on MRI and who refuse pituitary surgery or for whom pituitary surgery is contraindicated
Patients for whom written informed consent to participate in the study has been obtained prior to any study related activity
Exclusion criteria:
Patients who are being or were treated with octreotide, lanreotide, dopamine agonists or GH antagonists with the exception of a single dose of short-acting octrotide or short-acting dopamine agonists. In case of a single dose of short-acting octrotide, the dose should not be used to predict the response to the octretide treatment. The single dose of short-acting octreotide or short-acting dopamine agonists should not be administered in the 3 days prior to randomization
Patients with compression of the optic chiasm causing any visual field defect
Patients who have received pituitary irradiation within the last ten years prior to visit 1
Poorly controlled diabetic patients
Other protocol-defined inclusion/exclusion criteria may apply
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Director
Novartis
Novartis
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Cedars Sinai Medical Center The Pituitary Center
Los Angeles
California
90048
United States
University of California at Los Angeles Division of Endocrinology
Bronstein MD, Fleseriu M, Neggers S, Colao A, Sheppard M, Gu F, Shen CC, Gadelha M, Farrall AJ, Hermosillo Resendiz K, Ruffin M, Chen Y, Freda P; Pasireotide C2305 Study Group. Switching patients with acromegaly from octreotide to pasireotide improves biochemical control: crossover extension to a randomized, double-blind, Phase III study. BMC Endocr Disord. 2016 Apr 2;16:16. doi: 10.1186/s12902-016-0096-8.
Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension.
Periods
Title
Milestones
Reasons Not Completed
Core Phase - Full Analysis Set (FAS)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Australia
Portugal
Venezuela
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
SOM230
Octreotide
Drug
Octreotide LAR - i.m. depot injection given once every 28 days.
Octreotide LAR
12 Months
Change From Baseline in Tumor Volume at 12 Months
Absolute and percentage change from baseline in tumor volume (assessed by pituitary MRI) Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.
Baseline, 12 Months
Percentage of Participants With Normalization of IGF-1
Percentage of participants with normalization of sex- and age-adjusted IGF-1. Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.
12 Months
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1
Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1.
Denominator for time points up to Month 12 is the Full Analysis Set (FAS). Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover. Analysis was based on data up to crossover (i.e., included data from both blinded core & ext. phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included.)
Months 3, 6, 9, 12, 16, 19, 22, 25
Summary of Mean GH Values
Mean GH levels (based on a 5-point profile over 2 hours). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Baseline, Months 3, 6, 9, 12, 16, 19, 22, 25
Time to First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 (No. of Responders: Pasireotite LAR = 81, Octreotide LAR = 63) )
Time to first response for patients achieving a reduction of mean GH level to < 2.5 μg/L and normalization of IGF-1. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Up to 26 months
Severity Scores of Acromegaly Symptoms
Severity scores of acromegaly symptoms (Headache, Fatigue, Perspiration, Paresthesias, Osteoarthralgia). Symptoms were scored from 0 (no symptom) to 4 (very severe). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Baseline, Months 12, 25
Ring Size
Ring size (based on jeweler's finger gauge). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Baseline, Months 12, 25
Health-related Quality-of-life as Measured by the AcroQoL Questionnaire
Acromegalyy quality of life (AcroQoL) total scores. The AcroQoL questionnaire is unidimensional and contains 22 items divided in two scales: one that evaluates physical aspects (eight items) and another one that evaluates psychological aspects (14 items). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Baseline, Months 12, 25
Summary of Prolactin Levels
Prolactin Levels. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Baseline, Months 12, 25
Duration of Response for Patients Achieving a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 at Month 12 (No. of Responders: Pasireotide LAR = 51, Octreotide LAR = 32)
The duration of response is defined as the time from the date that patient first met and maintained the response criteria based on primary efficacy variable to the date that patient lost response status.
Median and corresponding 95% CI are derived based on Kaplan-Meier method. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Up to 26 months
Pasireotide Trough Concentrations by Incident Dose
Pasireotide LAR trough concentrations by incident dose (last dose administered prior to PK sample collection). PK observations with missing concentrations, missing dose, missing elapsed time or an elapsed time from previous injection outside of 28±2 days window were excluded.
5 patients with evaluable PK data in the pasireotide arm received erroneously 20 mg pasireotide LAR at baseline.
Months 1 - 12
Octreotide Trough Concentrations by Incident Dose
Octreotide LAR trough concentrations by incident dose (last dose administered prior to PK sample collection). PK observations with missing concentrations, missing dose, missing elapsed time or an elapsed time from previous injection outside of 28±2 days window were excluded.
Months 1 - 12
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 After Crossover
Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).
Months 3, 6, 9, 12 after crossover
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L
Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile).
Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). Denominator for time points up to Month 12 is the Full Analysis Set. Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover.
Months 3, 6, 9, 12, 16, 19, 22, 25
Percentage of Participants With Normalization of IGF-1
Percentage of participants with normalization of sex- and age-adjusted IGF-1. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). Denominator for time points up to Month 12 is the FAS. Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover.
Months 3, 6, 9, 12, 16, 19, 22, 25
Change From Baseline in Tumor Volume
Percentage change from baseline in tumor volume (assessed by pituitary MRI). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Baseline, months 6, 12, 19, 25
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L After Crossover
Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile). Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).
Months 3, 6, 9, 12 after crossover
Percentage of Participants With Normalization of IGF-1 After Crossover
Percentage of participants with normalization of sex- and age-adjusted IGF-1. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).
Months 3, 6, 9, 12 after crossover
Summary of Mean GH Values After Crossover
Mean GH levels (based on a 5-point profile over 2 hours). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over).
Extension baseline, months 3, 6, 9, 12 after crossover
Change From Extension Baseline in Tumor Volume After Crossover
Percentage change from extension baseline in tumor volume (assessed by pituitary MRI).
Extension baseline was defined as last assessment prior to the administration of the new treatment after crossover. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over).
Extension baseline, months 6, 12 after crossover
Severity Scores of Acromegaly Symptoms After Crossover
Severity scores of acromegaly symptoms (Headache, Fatigue, Perspiration, Paresthesias, Osteoarthralgia).
Symptoms were scored from 0 (no symptom) to 4 (very severe). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over).
Extension baseline, month 12 after crossover
Ring Size After Crossover
Ring size (based on jeweler's finger gauge). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). BL = baseline, LH = left hand, RH = right hand, CO = crossover
Extension baseline, month 12 after crossover
Health-related Quality-of-life as Measured by the AcroQoL Questionnaire After Crossover
AcroQoL total scores. The AcroQoL questionnaire is unidimensional and contains 22 items divided in two scales: one that evaluates physical aspects (eight items) and another one that evaluates psychological aspects (14 items). The scoring of the questionnaire was performed as specified by the instrument developers. Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Total scores range from 0 to 100. Higher scores represent better quality of life.
Extension baseline, months 12 after crossover
Summary of Prolactin Levels After Crossover
Prolactin (PRL) levels. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Extension baseline was defined as last measurement prior to the start of crossover treatment.
Extension baseline, month 12 after crossover
Los Angeles
California
90095
United States
Stanford University Medical Center Stanford Cancer Center (3)
Stanford
California
94304
United States
University of Florida SC
Gainesville
Florida
32610
United States
Johns Hopkins University School of Medicine Dept.ofJohnsHopkinsUniv.
Baltimore
Maryland
21205
United States
University of Michigan Comprehensive Cancer Center Deptof Endocrinology&Diabetes
Ann Arbor
Michigan
48109-0944
United States
Columbia University Medical Center- New York Presbyterian Dept. of CU Collegeof Phys&Sur
New York
New York
10032
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Northport VA Medical Center CSOM230C2305
Northport
New York
11768
United States
Oregon Health & Sciences University DeptofOregonHealth&Sciences(3)
Portland
Oregon
97201
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Allegheny Endocrinology Associates
Pittsburgh
Pennsylvania
15212
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University of Texas Southwestern Medical Center Danziger Research Bldg.
Dallas
Texas
75390
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University of Texas/MD Anderson Cancer Center Regulatory -12
Houston
Texas
77030-4009
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Baylor College of Medicine
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77030
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Derived
Shanik MH, Cao PD, Ludlam WH. HISTORICAL RESPONSE RATES OF SOMATOSTATIN ANALOGUES IN THE TREATMENT OF ACROMEGALY: A SYSTEMATIC REVIEW. Endocr Pract. 2016 Mar;22(3):350-6. doi: 10.4158/EP15913.RA. Epub 2015 Oct 5.
Sheppard M, Bronstein MD, Freda P, Serri O, De Marinis L, Naves L, Rozhinskaya L, Hermosillo Resendiz K, Ruffin M, Chen Y, Colao A. Pasireotide LAR maintains inhibition of GH and IGF-1 in patients with acromegaly for up to 25 months: results from the blinded extension phase of a randomized, double-blind, multicenter, Phase III study. Pituitary. 2015 Jun;18(3):385-94. doi: 10.1007/s11102-014-0585-6.
FG001
Octreotide LAR
Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension.
FG000176 subjects
FG001182 subjects
Did Not Enter Extension
FG00029 subjects
FG00129 subjects
Entered Extension, Crossed Over
FG00038 subjects
FG00181 subjects
Entered Ext Continued Same Treatment
FG00074 subjects
FG00146 subjects
COMPLETED
FG000141 subjectsCompleted = anyone who did not discontinue prior to month 12.
FG001156 subjectsCompleted = anyone who did not discontinue prior to month 12.
NOT COMPLETED
FG00035 subjects
FG00126 subjects
Type
Comment
Reasons
Adverse Event
FG00014 subjects
FG0016 subjects
Protocol Violation
FG0007 subjects
FG0018 subjects
Lack of Efficacy
FG0005 subjects
FG0018 subjects
Withdrawal by Subject
FG0005 subjects
FG0013 subjects
Administrative Problems
FG0002 subjects
FG0010 subjects
Abnormal laboratory value(s)
FG0001 subjects
FG0010 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
Death
FG0000 subjects
FG0011 subjects
Extension - Same Treatment (FAS)
Type
Comment
Milestone Data
STARTED
FG00074 subjectsStarted = anyone who entered the extension and continued the same treatment of Pasireotide LAR
FG00146 subjectsStarted = anyone who entered the extension and continued the same treatment of Octreotide LAR
Completed Study at Month 26
FG0000 subjectsPas. LAR pts in Ext. were not considered completers at M26 as treatment could continue after M26.
FG00131 subjectsPer protocol, pts who received Octreotide LAR in ext. phase were not followed in the study after M26
Completed Study After Month 26
FG00028 subjectsCompleted = Pts who transferred to a roll-over protocol or commercial supply of Pasireotide LAR
FG0014 subjectsReceived treatment and completed after M26: Recorded as protocol deviation
Discontinued After Month 26
FG00023 subjects
FG0011 subjectsReceived treatment and discontinued after M26: Recorded as protocol deviation
Discontinued Between M12 and M26
FG00023 subjects
FG00110 subjects
COMPLETED
FG00028 subjectsCompleted= completed after M26, switched to commercial pasireotide LAR or entered roll-over protocol
FG00135 subjectsCompleted = completed the study
NOT COMPLETED
FG00046 subjects
FG00111 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG00016 subjects
FG0012 subjects
Lack of Efficacy
FG0003 subjects
FG001
Extension - After Crossover (CAS)
Type
Comment
Milestone Data
STARTED
FG00081 subjectsStarted = anyone who entered the extension and crossed over to Pasireotide LAR
FG00138 subjectsStarted = anyone who entered the extension and crossed over to Octreotide LAR
Completed Study at Month 26
FG0000 subjectsPas. LAR pts in Ext. were not considered completers at M26 as treatment could continue after M26.
FG00125 subjectsPer protocol, Pts who received Octreotide LAR in Ext. phase were not followed in study after M26
Completed After Month 26
FG00019 subjectsCompleted = Pts who transferred to a roll-over protocol or commercial supply of Pasireotide LAR
FG0010 subjectsPer protocol, pts who received Octreotide LAR in ext. phase were not followed in study after M26
Discontinued Between M12 and M26
FG00031 subjects
FG00113 subjects
Discontinued After M26
FG00031 subjects
FG0010 subjectsPer protocol, Pts who received Octreotide LAR in Ext. phase were not followed in study after M26
COMPLETED
FG00019 subjectsCompleted after month 26: transferred to a roll-over protocol or commercial supply of Pas.LAR
FG00125 subjectsCompleted the study
NOT COMPLETED
FG00062 subjects
FG00113 subjects
Type
Comment
Reasons
Adverse Event
FG00019 subjects
FG0011 subjects
Withdrawal by Subject
FG00019 subjects
FG001
Full Analysis Set: All patients who were randomized into the study. Patients were analyzed according to the treatment they were assigned to at randomization.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Pasireotide LAR
Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension.
BG001
Octreotide LAR
Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000176
BG001182
BG002358
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00045.1± 12.37
BG00145.6± 12.97
BG00245.4± 12.67
Age, Customized
Number
Participants
Title
Denominators
Categories
<65 Years
Title
Measurements
BG000168
BG001167
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00091
BG00195
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1
Percentage of participants with a reduction of mean GH levels to <2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1.
Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.
Full Analysis Set: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing mean GH and/or IGF-1 levels at M12 were imputed using data obtained at or after M6 by the last observation carried forward method; otherwise, Pts were considered as non-responders.
Posted
Number
95% Confidence Interval
Percentage of Participants
12 months
ID
Title
Description
OG000
Pasireotide LAR (Core)
Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
OG001
Octreotide LAR (Core)
Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
Units
Counts
Participants
OG000176
OG001182
Title
Denominators
Categories
Overall
ParticipantsOG000176
ParticipantsOG001182
Title
Measurements
OG00031.3(24.5 to 38.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Overall - All patients
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel adjusting for randomization stratification factor
0.007
Odds Ratio (OR)
1.942
2-Sided
95
1.190
3.168
Superiority or Other
OG000
OG001
Secondary
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L
Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile).
Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.
FAS: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing mean GH levels at Month 12 were imputed using data obtained at or after Month 6 by the LOCF (last observation carried forward) method; otherwise, Pts were considered as non-responders.
Posted
Number
95% Confidence Interval
Percentage of participants
12 Months
ID
Title
Description
OG000
Pasireotide LAR (Core)
Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
OG001
Octreotide LAR (Core)
Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
Units
Counts
Secondary
Change From Baseline in Tumor Volume at 12 Months
Absolute and percentage change from baseline in tumor volume (assessed by pituitary MRI) Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.
Full Analysis Set (FAS): All patients who were randomized into the study. Patients were analyzed according to the treatment they were assigned to at randomization.
Posted
Mean
Standard Deviation
mm^3
Baseline, 12 Months
ID
Title
Description
OG000
Pasireotide LAR (Core)
Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
OG001
Octreotide LAR (Core)
Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With Normalization of IGF-1
Percentage of participants with normalization of sex- and age-adjusted IGF-1. Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.
Full Analysis Set: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing IGF-1 levels at Month 12 were imputed using data obtained at or after Month 6 by the LOCF (last observation carried forward) method; otherwise, Pts were considered as nonresponders.
Posted
Number
95% Confidence Interval
Percentage of participants
12 Months
ID
Title
Description
OG000
Pasireotide LAR (Core)
Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
OG001
Octreotide LAR (Core)
Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
Units
Counts
Participants
Secondary
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1
Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1.
Denominator for time points up to Month 12 is the Full Analysis Set (FAS). Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover. Analysis was based on data up to crossover (i.e., included data from both blinded core & ext. phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included.)
Full Analysis Set: All patients who were randomized into the study.
Posted
Number
95% Confidence Interval
Percentage of participants
Months 3, 6, 9, 12, 16, 19, 22, 25
ID
Title
Description
OG000
Pasireotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
OG001
Octreotide LAR (Core & Extension)
Secondary
Summary of Mean GH Values
Mean GH levels (based on a 5-point profile over 2 hours). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Full Analysis Set: All patients who were randomized into the study.
Posted
Mean
Standard Deviation
μg/L
Baseline, Months 3, 6, 9, 12, 16, 19, 22, 25
ID
Title
Description
OG000
Pasireotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
OG001
Octreotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Secondary
Time to First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 (No. of Responders: Pasireotite LAR = 81, Octreotide LAR = 63) )
Time to first response for patients achieving a reduction of mean GH level to < 2.5 μg/L and normalization of IGF-1. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Full Analysis Set: All patients who were randomized into the study.
Posted
Median
95% Confidence Interval
Weeks
Up to 26 months
ID
Title
Description
OG000
Pasireotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
OG001
Octreotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Secondary
Severity Scores of Acromegaly Symptoms
Severity scores of acromegaly symptoms (Headache, Fatigue, Perspiration, Paresthesias, Osteoarthralgia). Symptoms were scored from 0 (no symptom) to 4 (very severe). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Full Analysis Set: All patients who were randomized into the study.
Posted
Mean
Standard Deviation
scores on a scale
Baseline, Months 12, 25
ID
Title
Description
OG000
Pasireotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
OG001
Octreotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Secondary
Ring Size
Ring size (based on jeweler's finger gauge). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Full Analysis Set: All patients who were randomized into the study.
Posted
Mean
Standard Deviation
ring zize
Baseline, Months 12, 25
ID
Title
Description
OG000
Pasireotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
OG001
Octreotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Units
Secondary
Health-related Quality-of-life as Measured by the AcroQoL Questionnaire
Acromegalyy quality of life (AcroQoL) total scores. The AcroQoL questionnaire is unidimensional and contains 22 items divided in two scales: one that evaluates physical aspects (eight items) and another one that evaluates psychological aspects (14 items). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Full Analysis Set: All patients who were randomized into the study.
Posted
Mean
Standard Deviation
Score on a scale
Baseline, Months 12, 25
ID
Title
Description
OG000
Pasireotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
OG001
Octreotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Secondary
Summary of Prolactin Levels
Prolactin Levels. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Full Analysis Set: All patients who were randomized into the study.
Posted
Mean
Standard Deviation
μg/L
Baseline, Months 12, 25
ID
Title
Description
OG000
Pasireotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
OG001
Octreotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Units
Secondary
Duration of Response for Patients Achieving a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 at Month 12 (No. of Responders: Pasireotide LAR = 51, Octreotide LAR = 32)
The duration of response is defined as the time from the date that patient first met and maintained the response criteria based on primary efficacy variable to the date that patient lost response status.
Median and corresponding 95% CI are derived based on Kaplan-Meier method. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Full Analysis Set: All patients who were randomized into the study.
Posted
Median
95% Confidence Interval
Weeks
Up to 26 months
ID
Title
Description
OG000
Pasireotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
OG001
Octreotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Secondary
Pasireotide Trough Concentrations by Incident Dose
Pasireotide LAR trough concentrations by incident dose (last dose administered prior to PK sample collection). PK observations with missing concentrations, missing dose, missing elapsed time or an elapsed time from previous injection outside of 28±2 days window were excluded.
5 patients with evaluable PK data in the pasireotide arm received erroneously 20 mg pasireotide LAR at baseline.
PK analysis set: All patients with at least one LAR injection and one post-dose trough concentration data in core phase (up to month 12). No participants took the 60 mg dose in Months 1, 2 and 3, hence no data.
Posted
Mean
Standard Deviation
ng/mL
Months 1 - 12
ID
Title
Description
OG000
Pasireotide LAR 20 mg
Patients in this arm received Pasireotide LAR 20 mg injection prior to PK sample collection.
OG001
Pasireotide LAR 40 mg
Patients in this arm received Pasireotide LAR 40 mg injection prior to PK sample collection.
OG002
Pasireotide LAR 60mg
Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Secondary
Octreotide Trough Concentrations by Incident Dose
Octreotide LAR trough concentrations by incident dose (last dose administered prior to PK sample collection). PK observations with missing concentrations, missing dose, missing elapsed time or an elapsed time from previous injection outside of 28±2 days window were excluded.
PK analysis set: All patients with at least one LAR injection and one post-dose trough concentration data in core phase (up to month 12). No participants took the 30 mg dose in Months 1, 2 and 3, hence no data.
Posted
Mean
Standard Deviation
ng/mL
Months 1 - 12
ID
Title
Description
OG000
Octreotide LAR 10mg
Patients in this arm received Octreotide LAR 10 mg injection prior to PK sample collection.
OG001
Octreotide LAR 20 mg
Patients in this arm received Octreotide LAR 20 mg injection prior to PK sample collection.
OG002
Octreotide LAR 30 mg
Patients in this arm received Octreotide LAR 30 mg injection prior to PK sample collection.
Secondary
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 After Crossover
Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).
Crossover Analysis Set (CAS): All patients whose first dose in the extension is different from the first dose in the core.
Patients were analyzed according to the crossover treatment received.
Posted
Number
95% Confidence Interval
Percentage of participants
Months 3, 6, 9, 12 after crossover
ID
Title
Description
OG000
Crossed Over to Pasireotide LAR (Extension)
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
OG001
Crossed Over to Octreotide LAR (Extension)
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
Secondary
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L
Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile).
Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). Denominator for time points up to Month 12 is the Full Analysis Set. Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover.
Full Analysis Set: All patients who were randomized into the study.
Posted
Number
95% Confidence Interval
Percentage of participants
Months 3, 6, 9, 12, 16, 19, 22, 25
ID
Title
Description
OG000
Pasireotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
OG001
Octreotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Secondary
Percentage of Participants With Normalization of IGF-1
Percentage of participants with normalization of sex- and age-adjusted IGF-1. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). Denominator for time points up to Month 12 is the FAS. Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover.
Full Analysis Set: All patients who were randomized into the study.
Posted
Number
95% Confidence Interval
Percentage of participants
Months 3, 6, 9, 12, 16, 19, 22, 25
ID
Title
Description
OG000
Pasireotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
OG001
Octreotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Secondary
Change From Baseline in Tumor Volume
Percentage change from baseline in tumor volume (assessed by pituitary MRI). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Full Analysis Set: All patients who were randomized into the study.
Posted
Mean
Standard Deviation
mm^3
Baseline, months 6, 12, 19, 25
ID
Title
Description
OG000
Pasireotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
OG001
Octreotide LAR (Core & Extension)
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Secondary
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L After Crossover
Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile). Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).
CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.
Posted
Number
95% Confidence Interval
Percentage of participants
Months 3, 6, 9, 12 after crossover
ID
Title
Description
OG000
Crossed Over to Pasireotide LAR (Extension)
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
OG001
Crossed Over to Octreotide LAR (Extension)
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
Secondary
Percentage of Participants With Normalization of IGF-1 After Crossover
Percentage of participants with normalization of sex- and age-adjusted IGF-1. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).
CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.
Posted
Number
95% Confidence Interval
Percentage of participants
Months 3, 6, 9, 12 after crossover
ID
Title
Description
OG000
Crossed Over to Pasireotide LAR (Extension)
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
OG001
Crossed Over to Octreotide LAR (Extension)
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
Secondary
Summary of Mean GH Values After Crossover
Mean GH levels (based on a 5-point profile over 2 hours). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over).
CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.
Posted
Mean
Standard Deviation
μg/L
Extension baseline, months 3, 6, 9, 12 after crossover
ID
Title
Description
OG000
Crossed Over to Pasireotide LAR (Extension)
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
OG001
Crossed Over to Octreotide LAR (Extension)
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
Secondary
Change From Extension Baseline in Tumor Volume After Crossover
Percentage change from extension baseline in tumor volume (assessed by pituitary MRI).
Extension baseline was defined as last assessment prior to the administration of the new treatment after crossover. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over).
CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.
Posted
Mean
Standard Deviation
mm^3
Extension baseline, months 6, 12 after crossover
ID
Title
Description
OG000
Crossed Over to Pasireotide LAR (Extension)
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
OG001
Crossed Over to Octreotide LAR (Extension)
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
Secondary
Severity Scores of Acromegaly Symptoms After Crossover
Severity scores of acromegaly symptoms (Headache, Fatigue, Perspiration, Paresthesias, Osteoarthralgia).
Symptoms were scored from 0 (no symptom) to 4 (very severe). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over).
CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.
Posted
Mean
Standard Deviation
scores on a scale
Extension baseline, month 12 after crossover
ID
Title
Description
OG000
Crossed Over to Pasireotide LAR (Extension)
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
OG001
Crossed Over to Octreotide LAR (Extension)
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
Secondary
Ring Size After Crossover
Ring size (based on jeweler's finger gauge). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). BL = baseline, LH = left hand, RH = right hand, CO = crossover
CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received. In the extension baseline, no participant had ring size on their right hand measured at the 5th digit, hence no data.
Posted
Mean
Standard Deviation
ring size
Extension baseline, month 12 after crossover
ID
Title
Description
OG000
Crossed Over to Pasireotide LAR (Extension)
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
OG001
Crossed Over to Octreotide LAR (Extension)
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
Secondary
Health-related Quality-of-life as Measured by the AcroQoL Questionnaire After Crossover
AcroQoL total scores. The AcroQoL questionnaire is unidimensional and contains 22 items divided in two scales: one that evaluates physical aspects (eight items) and another one that evaluates psychological aspects (14 items). The scoring of the questionnaire was performed as specified by the instrument developers. Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Total scores range from 0 to 100. Higher scores represent better quality of life.
CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.
Posted
Mean
Standard Deviation
scores on a scale
Extension baseline, months 12 after crossover
ID
Title
Description
OG000
Crossed Over to Pasireotide LAR (Extension)
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
OG001
Crossed Over to Octreotide LAR (Extension)
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
Secondary
Summary of Prolactin Levels After Crossover
Prolactin (PRL) levels. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Extension baseline was defined as last measurement prior to the start of crossover treatment.
CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.
Posted
Mean
Standard Deviation
μg/L
Extension baseline, month 12 after crossover
ID
Title
Description
OG000
Crossed Over to Pasireotide LAR (Extension)
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
OG001
Crossed Over to Octreotide LAR (Extension)
Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
Units
Counts
Time Frame
Not provided
Description
Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp.
Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Pasireotide LAR - up to 26 Months
Includes data from both blinded core and extension phase (up to Month 26 cutoff date of 29-Dec-2011) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment, only data collected before crossover is included.
35
178
169
178
EG001
Octreotide LAR - up to 26 Months
Includes data from both blinded core and extension phase (up to Month 26 cutoff date of 29-Dec-2011) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment, only data collected before crossover is included.
28
180
161
180
EG002
Crossed Over to Pasireotide LAR - up to 26 Months
Includes all data in the extension phase (up to 26-Month cutoff date of 29-Dec-2011) collected after the crossover time point for patients who crossed over from Octreotide LAR in the core to Pasireotide LAR treatment in the extension phase.
8
81
74
81
EG003
Crossed Over to Octreotide LAR - up to 26 Months
Includes all data in the extension phase (up to 26-Month cutoff date of 29-Dec-2011) collected after the crossover time point for patients who crossed over from Pasireotide LAR in the core to Octreotide LAR treatment in the extension phase.
6
38
33
38
EG004
Pasireotide LAR - up to EOS
Includes data from both core and extension phase (up to End-of-study date of 11-Mar-2016) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment, only data collected before crossover is included.
Per protocol, patients on Pasireotide LAR could continue to receive open-label Pasireotide LAR after treatment unblinding at Month 26, whereas those on Octreotide LAR were not followed after Month 26.
37
178
170
178
EG005
Crossed Over to Pasireotide LAR - up to EOS
Includes all data in the extension phase (up to End-of-study date of 11-Mar-2016) collected after the crossover time point for patients who crossed over from Octreotide LAR in the core to Pasireotide LAR treatment in the extension phase.
Per protocol, patients on Pasireotide LAR could continue to receive open-label Pasireotide LAR after treatment unblinding at Month 26, whereas those on Octreotide LAR were not followed after Month 26.
12
81
76
81
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG0030 affected38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Cardiovascular disorder
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Acromegaly
Endocrine disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Toxic nodular goitre
Endocrine disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0021 affected81 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0012 affected180 at risk
EG0020 affected81 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0021 affected81 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0021 affected81 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0021 affected81 at risk
EG003
Oesophageal obstruction
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Pancreatic cyst
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Chills
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Concomitant disease progression
General disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Fatigue
General disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Hernia
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Multi-organ failure
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Oedema peripheral
General disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Pyrexia
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0021 affected81 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (18.1)
Systematic Assessment
EG0005 affected178 at risk
EG0014 affected180 at risk
EG0022 affected81 at risk
EG003
Hydrocholecystis
Hepatobiliary disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Febrile infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Influenza
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Rectal abscess
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Renal abscess
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Septic shock
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0021 affected81 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Back injury
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Brain contusion
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0021 affected81 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0021 affected81 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0021 affected81 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0021 affected81 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Kidney rupture
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Post-traumatic neck syndrome
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Spinal column injury
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0021 affected81 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0012 affected180 at risk
EG0020 affected81 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0021 affected81 at risk
EG003
Blood sodium decreased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0021 affected81 at risk
EG003
Weight decreased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0003 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0021 affected81 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0021 affected81 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0021 affected81 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0021 affected81 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Chondritis
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Benign breast neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Cervix carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Hypopharyngeal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0021 affected81 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Mixed hepatocellular cholangiocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Pituitary tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Plasma cell myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Renal oncocytoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Respiratory papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0021 affected81 at risk
EG003
Diabetic hyperglycaemic coma
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Migraine
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Multiple sclerosis
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Seizure
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Catatonia
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Major depression
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Uterine prolapse
Reproductive system and breast disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Nasal polyps
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0021 affected81 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Chronic pigmented purpura
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Aortic aneurysm rupture
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0021 affected81 at risk
EG003
Arteriovenous fistula
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Hypertension
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Peripheral venous disease
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG00014 affected178 at risk
EG00110 affected180 at risk
EG0026 affected81 at risk
EG0031 affected38 at risk
EG00419 affected178 at risk
EG0058 affected81 at risk
Sinus bradycardia
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG00013 affected178 at risk
EG00110 affected180 at risk
EG0022 affected81 at risk
EG003
Cataract
Eye disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0011 affected180 at risk
EG0021 affected81 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0008 affected178 at risk
EG0011 affected180 at risk
EG0020 affected81 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG00021 affected178 at risk
EG00122 affected180 at risk
EG0020 affected81 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG00033 affected178 at risk
EG00143 affected180 at risk
EG0023 affected81 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG00012 affected178 at risk
EG00117 affected180 at risk
EG0023 affected81 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG00010 affected178 at risk
EG00119 affected180 at risk
EG0024 affected81 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG00070 affected178 at risk
EG00179 affected180 at risk
EG00220 affected81 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0008 affected178 at risk
EG0017 affected180 at risk
EG0023 affected81 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG00010 affected178 at risk
EG00111 affected180 at risk
EG0020 affected81 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected178 at risk
EG0012 affected180 at risk
EG0022 affected81 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0022 affected81 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG00027 affected178 at risk
EG00141 affected180 at risk
EG0028 affected81 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG00019 affected178 at risk
EG00115 affected180 at risk
EG0023 affected81 at risk
EG003
Fatigue
General disorders
MedDRA (18.1)
Systematic Assessment
EG00020 affected178 at risk
EG00121 affected180 at risk
EG0026 affected81 at risk
EG003
Injection site pain
General disorders
MedDRA (18.1)
Systematic Assessment
EG00013 affected178 at risk
EG0019 affected180 at risk
EG0020 affected81 at risk
EG003
Pyrexia
General disorders
MedDRA (18.1)
Systematic Assessment
EG0008 affected178 at risk
EG00110 affected180 at risk
EG0021 affected81 at risk
EG003
Biliary dilatation
Hepatobiliary disorders
MedDRA (18.1)
Systematic Assessment
EG0005 affected178 at risk
EG0018 affected180 at risk
EG0024 affected81 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (18.1)
Systematic Assessment
EG00056 affected178 at risk
EG00169 affected180 at risk
EG00218 affected81 at risk
EG003
Gallbladder polyp
Hepatobiliary disorders
MedDRA (18.1)
Systematic Assessment
EG0005 affected178 at risk
EG0013 affected180 at risk
EG0024 affected81 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA (18.1)
Systematic Assessment
EG00010 affected178 at risk
EG00111 affected180 at risk
EG0026 affected81 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG00010 affected178 at risk
EG0014 affected180 at risk
EG0020 affected81 at risk
EG003
Influenza
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG00016 affected178 at risk
EG00111 affected180 at risk
EG0023 affected81 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG00032 affected178 at risk
EG00129 affected180 at risk
EG00213 affected81 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0006 affected178 at risk
EG0016 affected180 at risk
EG0022 affected81 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG00016 affected178 at risk
EG0017 affected180 at risk
EG0023 affected81 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0009 affected178 at risk
EG00112 affected180 at risk
EG0025 affected81 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG00015 affected178 at risk
EG00110 affected180 at risk
EG0023 affected81 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG00012 affected178 at risk
EG0018 affected180 at risk
EG0023 affected81 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0009 affected178 at risk
EG0015 affected180 at risk
EG0021 affected81 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG00025 affected178 at risk
EG00124 affected180 at risk
EG0027 affected81 at risk
EG003
Blood glucose increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG00017 affected178 at risk
EG0016 affected180 at risk
EG0028 affected81 at risk
EG003
Blood thyroid stimulating hormone decreased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0004 affected178 at risk
EG0012 affected180 at risk
EG0021 affected81 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0004 affected178 at risk
EG0014 affected180 at risk
EG0022 affected81 at risk
EG003
Blood uric acid increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0006 affected178 at risk
EG0013 affected180 at risk
EG0021 affected81 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA (18.1)
Systematic Assessment
EG0009 affected178 at risk
EG00110 affected180 at risk
EG0023 affected81 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0003 affected178 at risk
EG00111 affected180 at risk
EG0021 affected81 at risk
EG003
Glycosylated haemoglobin increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG00011 affected178 at risk
EG0015 affected180 at risk
EG0027 affected81 at risk
EG003
Insulin-like growth factor decreased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0001 affected178 at risk
EG0010 affected180 at risk
EG0021 affected81 at risk
EG003
Lipase increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG00010 affected178 at risk
EG00113 affected180 at risk
EG0023 affected81 at risk
EG003
Weight decreased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0009 affected178 at risk
EG0018 affected180 at risk
EG0022 affected81 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG00038 affected178 at risk
EG0018 affected180 at risk
EG00218 affected81 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0003 affected178 at risk
EG0011 affected180 at risk
EG0025 affected81 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0007 affected178 at risk
EG0014 affected180 at risk
EG0022 affected81 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG00055 affected178 at risk
EG00118 affected180 at risk
EG00225 affected81 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0005 affected178 at risk
EG0014 affected180 at risk
EG0025 affected81 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0005 affected178 at risk
EG0012 affected180 at risk
EG0021 affected81 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG00011 affected178 at risk
EG00114 affected180 at risk
EG0027 affected81 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG00012 affected178 at risk
EG0010 affected180 at risk
EG0023 affected81 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG00021 affected178 at risk
EG00125 affected180 at risk
EG00210 affected81 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG00022 affected178 at risk
EG00121 affected180 at risk
EG0026 affected81 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0008 affected178 at risk
EG00110 affected180 at risk
EG0027 affected81 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0007 affected178 at risk
EG0013 affected180 at risk
EG0021 affected81 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0004 affected178 at risk
EG0014 affected180 at risk
EG0021 affected81 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG00014 affected178 at risk
EG0018 affected180 at risk
EG0026 affected81 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG00021 affected178 at risk
EG00120 affected180 at risk
EG0027 affected81 at risk
EG003
Headache
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG00041 affected178 at risk
EG00149 affected180 at risk
EG00217 affected81 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0008 affected178 at risk
EG0014 affected180 at risk
EG0020 affected81 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0009 affected178 at risk
EG0017 affected180 at risk
EG0021 affected81 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0008 affected178 at risk
EG0019 affected180 at risk
EG0022 affected81 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0006 affected178 at risk
EG0012 affected180 at risk
EG0021 affected81 at risk
EG003
Pyelocaliectasis
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected178 at risk
EG0010 affected180 at risk
EG0020 affected81 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG00011 affected178 at risk
EG00117 affected180 at risk
EG0021 affected81 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0008 affected178 at risk
EG00115 affected180 at risk
EG0023 affected81 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG00034 affected178 at risk
EG00136 affected180 at risk
EG0023 affected81 at risk
EG003
Hypertension
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG00018 affected178 at risk
EG00116 affected180 at risk
EG0025 affected81 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis Pharmaceuticals
862-778-8300
ID
Term
D000172
Acromegaly
Ancestor Terms
ID
Term
D001849
Bone Diseases, Endocrine
D001847
Bone Diseases
D009140
Musculoskeletal Diseases
D006964
Hyperpituitarism
D010900
Pituitary Diseases
D007027
Hypothalamic Diseases
D001927
Brain Diseases
D002493
Central Nervous System Diseases
D009422
Nervous System Diseases
D004700
Endocrine System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C517782
pasireotide
D015282
Octreotide
Ancestor Terms
ID
Term
D010456
Peptides, Cyclic
D047028
Macrocyclic Compounds
D011083
Polycyclic Compounds
D010455
Peptides
D000602
Amino Acids, Peptides, and Proteins
Browse Leaves
Not provided
Browse Branches
Not provided
3 subjects
Administrative Problems
FG0009 subjects
FG0013 subjects
Lost to Follow-up
FG0003 subjects
FG0011 subjects
Adverse Event
FG0004 subjects
FG0011 subjects
Abnormal Lab Value (s)
FG0004 subjects
FG0010 subjects
Death
FG0001 subjects
FG0011 subjects
Condition no longer requires study drug
FG0006 subjects
FG0010 subjects
4 subjects
Lack of Efficacy
FG00013 subjects
FG0014 subjects
Administrative Problems
FG0004 subjects
FG0014 subjects
Subject no longer requires study drug
FG0003 subjects
FG0010 subjects
Abnormal Lab Value (s)
FG0003 subjects
FG0010 subjects
Death
FG0001 subjects
FG0010 subjects
335
>=65 years
Title
Measurements
BG0008
BG00115
BG00223
186
Male
BG00085
BG00187
BG002172
OG00119.2(13.8 to 25.7)
Post Surgery
ParticipantsOG00071
ParticipantsOG00178
Title
Measurements
OG00039.4(28.0 to 51.7)
OG00121.8(13.2 to 32.6)
De novo
ParticipantsOG000105
ParticipantsOG001104
Title
Measurements
OG00025.7(17.7 to 35.2)
OG00117.3(10.6 to 26.0)
Post surgery - patients with prior surgery but no previous medical treatment for acromegaly
Odds Ratio (OR)
2.337
2-Sided
95
1.140
4.790
Superiority or Other
OG000
OG001
De novo - patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.
Odds Ratio (OR)
1.654
2-Sided
95
0.846
3.234
Superiority or Other
Participants
OG000176
OG001182
Title
Denominators
Categories
Overall
ParticipantsOG000176
ParticipantsOG001182
Title
Measurements
OG00048.3(40.7 to 55.9)
OG00151.6(44.1 to 59.1)
Post surgery
ParticipantsOG00071
ParticipantsOG00178
Title
Measurements
OG00052.1(39.9 to 64.1)
OG001
De novo
ParticipantsOG000105
ParticipantsOG001104
Title
Measurements
OG00045.7(36.0 to 55.7)
OG001
176
OG001182
Title
Denominators
Categories
Overall at baseline
ParticipantsOG000166
ParticipantsOG001169
Title
Measurements
OG0002420.7± 4159.21
OG0012259.2± 3390.20
Overall % change at month 12
ParticipantsOG000120
ParticipantsOG001124
Title
Measurements
OG000-39.7± 21.83
OG001
Post surgery at baseline
ParticipantsOG00070
ParticipantsOG00174
Title
Measurements
OG0002185.2± 2861.09
OG001
Post surgery % change at month 12
ParticipantsOG00044
ParticipantsOG00152
Title
Measurements
OG000-39.5± 20.60
OG001
De novo at baseline
ParticipantsOG00096
ParticipantsOG00195
Title
Measurements
OG0002592.4± 4901.99
OG001
De novo % change at month 12
ParticipantsOG00076
ParticipantsOG00172
Title
Measurements
OG000-39.9± 22.65
OG001
Overall absolute change at month 12
ParticipantsOG000121
ParticipantsOG001128
Title
Measurements
OG000-987.1± 2448.14
OG001
Post surgery abs. change at month 12
ParticipantsOG00044
ParticipantsOG00155
Title
Measurements
OG000-873.7± 1282.06
OG001
De novo absolute change at month 12
ParticipantsOG00077
ParticipantsOG00173
Title
Measurements
OG000-1051.9± 2919.18
OG001
OG000176
OG001182
Title
Denominators
Categories
Overall
ParticipantsOG000176
ParticipantsOG001182
Title
Measurements
OG00038.6(31.4 to 46.3)
OG00123.6(17.7 to 30.5)
Post surgery
ParticipantsOG00071
ParticipantsOG00178
Title
Measurements
OG00050.7(38.6 to 62.8)
OG001
De novo
ParticipantsOG000105
ParticipantsOG001104
Title
Measurements
OG00030.5(21.9 to 40.2)
OG001
Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
Units
Counts
Participants
OG000176
OG001182
Title
Denominators
Categories
Month 3
ParticipantsOG000176
ParticipantsOG001182
Title
Measurements
OG00030.1(23.4 to 37.5)
OG00121.4(15.7 to 28.1)
Month 6
ParticipantsOG000176
ParticipantsOG001182
Title
Measurements
OG00030.1(23.4 to 37.5)
OG001
Month 9
ParticipantsOG000176
ParticipantsOG001182
Title
Measurements
OG00027.8(21.4 to 35.1)
OG001
Month 12
ParticipantsOG000176
ParticipantsOG001182
Title
Measurements
OG00029.0(22.4 to 36.3)
OG001
Month 16
ParticipantsOG000147
ParticipantsOG001153
Title
Measurements
OG00025.2(18.4 to 33.0)
OG001
Month 19
ParticipantsOG000147
ParticipantsOG001153
Title
Measurements
OG00023.1(16.6 to 30.8)
OG001
Month 22
ParticipantsOG000147
ParticipantsOG001153
Title
Measurements
OG00025.2(18.4 to 33.0)
OG001
Month 25
ParticipantsOG000147
ParticipantsOG001153
Title
Measurements
OG00024.5(17.8 to 32.3)
OG001
Units
Counts
Participants
OG000176
OG001182
Title
Denominators
Categories
Baseline
ParticipantsOG000167
ParticipantsOG001178
Title
Measurements
OG00021.9± 32.14
OG00118.8± 25.95
Month 3
ParticipantsOG000164
ParticipantsOG001173
Title
Measurements
OG0006.3± 12.54
OG001
Month 6
ParticipantsOG000151
ParticipantsOG001165
Title
Measurements
OG0005.6± 11.47
OG001
Month 9
ParticipantsOG000136
ParticipantsOG001157
Title
Measurements
OG0004.9± 9.62
OG001
Month 12
ParticipantsOG000136
ParticipantsOG001151
Title
Measurements
OG0004.6± 9.51
OG001
Month 16
ParticipantsOG00064
ParticipantsOG00138
Title
Measurements
OG0002.3± 5.64
OG001
Month 19
ParticipantsOG00062
ParticipantsOG00138
Title
Measurements
OG0002.1± 5.68
OG001
Month 22
ParticipantsOG00060
ParticipantsOG00139
Title
Measurements
OG0002.1± 6.15
OG001
Month 25
ParticipantsOG00062
ParticipantsOG00140
Title
Measurements
OG0002.0± 5.02
OG001
Units
Counts
Participants
OG000176
OG001182
Title
Denominators
Categories
Title
Measurements
OG00012.6(12.3 to 13.0)
OG00112.4(12.3 to 13.7)
Units
Counts
Participants
OG000176
OG001182
Title
Denominators
Categories
Headache - Baseline
ParticipantsOG000175
ParticipantsOG001181
Title
Measurements
OG0000.9± 1.05
OG0011.0± 1.14
Fatigue - Baseline
ParticipantsOG000175
ParticipantsOG001181
Title
Measurements
OG0001.2± 1.13
OG001
Perspiration - Baseline
ParticipantsOG000175
ParticipantsOG001181
Title
Measurements
OG0001.1± 1.21
OG001
Paresthesia - Baseline
ParticipantsOG000175
ParticipantsOG001180
Title
Measurements
OG0000.7± 1.00
OG001
Osteoarthraliga - Baseline
ParticipantsOG000174
ParticipantsOG001178
Title
Measurements
OG0001.0± 1.05
OG001
Headache - M12
ParticipantsOG000138
ParticipantsOG001149
Title
Measurements
OG0000.5± 0.77
OG001
Fatigue - M12
ParticipantsOG000138
ParticipantsOG001149
Title
Measurements
OG0000.8± 0.95
OG001
Perspiration - M12
ParticipantsOG000138
ParticipantsOG001149
Title
Measurements
OG0000.4± 0.81
OG001
Paresthesia - M12
ParticipantsOG000138
ParticipantsOG001149
Title
Measurements
OG0000.3± 0.63
OG001
Osteoarthraliga - M12
ParticipantsOG000137
ParticipantsOG001149
Title
Measurements
OG0000.5± 0.80
OG001
Headache - M25
ParticipantsOG00064
ParticipantsOG00140
Title
Measurements
OG0000.4± 0.61
OG001
Fatigue - M25
ParticipantsOG00064
ParticipantsOG00140
Title
Measurements
OG0000.5± 0.71
OG001
Perspiration - M25
ParticipantsOG00064
ParticipantsOG00140
Title
Measurements
OG0000.4± 0.72
OG001
Paresthesia - M25
ParticipantsOG00064
ParticipantsOG00140
Title
Measurements
OG0000.2± 0.49
OG001
Osteoarthraliga - M25
ParticipantsOG00064
ParticipantsOG00140
Title
Measurements
OG0000.4± 0.79
OG001
Counts
Participants
OG000176
OG001182
Title
Denominators
Categories
Baseline left hand (LH) 4th digit
ParticipantsOG000112
ParticipantsOG001115
Title
Measurements
OG00011.6± 2.00
OG00111.8± 1.97
Baseline left hand 5th digit
ParticipantsOG00021
ParticipantsOG00118
Title
Measurements
OG00011.7± 2.82
OG001
Baseline right hand (RH) 4th digit
ParticipantsOG00023
ParticipantsOG00129
Title
Measurements
OG00012.5± 2.01
OG001
Baseline right hand 5th digit
ParticipantsOG0005
ParticipantsOG0018
Title
Measurements
OG00011.2± 3.35
OG001
M12 LH 4th digit
ParticipantsOG00097
ParticipantsOG001102
Title
Measurements
OG00010.6± 2.05
OG001
M12 LH 5th digit
ParticipantsOG00012
ParticipantsOG00110
Title
Measurements
OG00011.8± 1.81
OG001
M12 RH 4th digit
ParticipantsOG00021
ParticipantsOG00125
Title
Measurements
OG00012.2± 2.12
OG001
M12 RH 5th digit
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG00010.7± 3.96
OG001
M25 LH 4th digit
ParticipantsOG00049
ParticipantsOG00133
Title
Measurements
OG00010.1± 2.12
OG001
M25 LH 5th digit
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG00010.0± 2.45
OG001
M25 RH 4th digit
ParticipantsOG0008
ParticipantsOG0014
Title
Measurements
OG00011.8± 1.98
OG001
M25 RH 5th digit
ParticipantsOG0002
ParticipantsOG0011
Title
Measurements
OG0007.8± 4.60
OG001
Units
Counts
Participants
OG000176
OG001182
Title
Denominators
Categories
Baseline
ParticipantsOG000173
ParticipantsOG001178
Title
Measurements
OG00058.4± 19.97
OG00155.6± 19.79
M12
ParticipantsOG000136
ParticipantsOG001148
Title
Measurements
OG00065.7± 21.64
OG001
M25
ParticipantsOG00058
ParticipantsOG00138
Title
Measurements
OG00069.3± 18.76
OG001
Counts
Participants
OG000176
OG001182
Title
Denominators
Categories
Baseline
ParticipantsOG000176
ParticipantsOG001182
Title
Measurements
OG00020.6± 53.00
OG00115.8± 22.05
M12
ParticipantsOG000135
ParticipantsOG001146
Title
Measurements
OG0008.9± 19.24
OG001
M25
ParticipantsOG00063
ParticipantsOG00140
Title
Measurements
OG0005.4± 4.37
OG001
Units
Counts
Participants
OG000176
OG001182
Title
Denominators
Categories
Title
Measurements
OG00064.4(52.1 to 100.4)
OG00164.6(40.0 to 92.0)
Units
Counts
Participants
OG000172
OG001172
OG002172
Title
Denominators
Categories
M1
ParticipantsOG0005
ParticipantsOG001146
ParticipantsOG0020
Title
Measurements
OG0004.65± 0.645
OG0016.65± 3.641
M2
ParticipantsOG0006
ParticipantsOG001135
ParticipantsOG0020
Title
Measurements
OG000
M3
ParticipantsOG0002
ParticipantsOG001135
ParticipantsOG0020
Title
Measurements
OG000
M4
ParticipantsOG0003
ParticipantsOG00188
ParticipantsOG00249
Title
Measurements
OG000
M5
ParticipantsOG0004
ParticipantsOG00177
ParticipantsOG00256
Title
Measurements
OG000
M6
ParticipantsOG0003
ParticipantsOG00171
ParticipantsOG00257
Title
Measurements
OG000
M7
ParticipantsOG0003
ParticipantsOG00169
ParticipantsOG00260
Title
Measurements
OG000
M8
ParticipantsOG0003
ParticipantsOG00163
ParticipantsOG00270
Title
Measurements
OG000
M9
ParticipantsOG0004
ParticipantsOG00159
ParticipantsOG00265
Title
Measurements
OG000
M10
ParticipantsOG0005
ParticipantsOG00161
ParticipantsOG00259
Title
Measurements
OG000
M11
ParticipantsOG0005
ParticipantsOG00153
ParticipantsOG00265
Title
Measurements
OG000
M12
ParticipantsOG0004
ParticipantsOG00145
ParticipantsOG00258
Title
Measurements
OG000
Units
Counts
Participants
OG000178
OG001178
OG002178
Title
Denominators
Categories
M1
ParticipantsOG0000
ParticipantsOG001153
ParticipantsOG0020
Title
Measurements
OG0010.86± 0.493
M2
ParticipantsOG0002
ParticipantsOG001139
ParticipantsOG0020
Title
Measurements
OG000
M3
ParticipantsOG0002
ParticipantsOG001134
ParticipantsOG0020
Title
Measurements
OG000
M4
ParticipantsOG0001
ParticipantsOG00179
ParticipantsOG00264
Title
Measurements
OG000
M5
ParticipantsOG0000
ParticipantsOG00163
ParticipantsOG00282
Title
Measurements
OG001
M6
ParticipantsOG0002
ParticipantsOG00162
ParticipantsOG00288
Title
Measurements
OG000
M7
ParticipantsOG0001
ParticipantsOG00161
ParticipantsOG00282
Title
Measurements
OG000
M8
ParticipantsOG0000
ParticipantsOG00150
ParticipantsOG00288
Title
Measurements
OG001
M9
ParticipantsOG0000
ParticipantsOG00147
ParticipantsOG00293
Title
Measurements
OG001
M10
ParticipantsOG0000
ParticipantsOG00149
ParticipantsOG00282
Title
Measurements
OG001
M11
ParticipantsOG0000
ParticipantsOG00143
ParticipantsOG00287
Title
Measurements
OG001
M12
ParticipantsOG0001
ParticipantsOG00137
ParticipantsOG00276
Title
Measurements
OG000
Units
Counts
Participants
OG00081
OG00138
Title
Denominators
Categories
M3 after crossover
Title
Measurements
OG00017.3(9.8 to 27.3)
OG0012.6(0.1 to 13.8)
M6 after crossover
Title
Measurements
OG00021.0(12.7 to 31.5)
OG0012.6(0.1 to 13.8)
M9 after crossover
Title
Measurements
OG00022.2(13.7 to 32.8)
OG0015.3(0.6 to 17.7)
M12 after crossover
Title
Measurements
OG00017.3(9.8 to 27.3)
OG0010.0(NA to NA)N/A = For zero proportions, confidence intervals were not calculated
Units
Counts
Participants
OG000176
OG001182
Title
Denominators
Categories
M3
ParticipantsOG000176
ParticipantsOG001182
Title
Measurements
OG00049.4(41.8 to 57.1)
OG00143.4(36.1 to 50.9)
M6
ParticipantsOG000176
ParticipantsOG001182
Title
Measurements
OG00045.5(37.9 to 53.1)
OG001
M9
ParticipantsOG000176
ParticipantsOG001182
Title
Measurements
OG00042.6(35.2 to 50.3)
OG001
M12
ParticipantsOG000176
ParticipantsOG001182
Title
Measurements
OG00043.2(35.8 to 50.8)
OG001
M16
ParticipantsOG000147
ParticipantsOG001153
Title
Measurements
OG00033.3(25.8 to 41.6)
OG001
M19
ParticipantsOG000147
ParticipantsOG001153
Title
Measurements
OG00036.7(28.9 to 45.1)
OG001
M22
ParticipantsOG000147
ParticipantsOG001153
Title
Measurements
OG00035.4(27.7 to 43.7)
OG001
M25
ParticipantsOG000147
ParticipantsOG001153
Title
Measurements
OG00035.4(27.7 to 43.7)
OG001
Units
Counts
Participants
OG000176
OG001182
Title
Denominators
Categories
M3
ParticipantsOG000176
ParticipantsOG001182
Title
Measurements
OG00035.2(28.2 to 42.8)
OG00125.3(19.1 to 32.2)
M6
ParticipantsOG000176
ParticipantsOG001182
Title
Measurements
OG00035.8(28.7 to 43.4)
OG001
M9
ParticipantsOG000176
ParticipantsOG001182
Title
Measurements
OG00034.1(27.1 to 41.6)
OG001
M12
ParticipantsOG000176
ParticipantsOG001182
Title
Measurements
OG00035.8(28.7 to 43.4)
OG001
M16
ParticipantsOG000147
ParticipantsOG001153
Title
Measurements
OG00029.9(22.7 to 38.0)
OG001
M19
ParticipantsOG000147
ParticipantsOG001153
Title
Measurements
OG00025.2(18.4 to 33.0)
OG001
M22
ParticipantsOG000147
ParticipantsOG001153
Title
Measurements
OG00025.9(19.0 to 33.7)
OG001
M25
ParticipantsOG000147
ParticipantsOG001153
Title
Measurements
OG00025.9(19.0 to 33.7)
OG001
Units
Counts
Participants
OG000176
OG001182
Title
Denominators
Categories
Baseline
ParticipantsOG000166
ParticipantsOG001169
Title
Measurements
OG0002420.7± 4159.21
OG0012259.2± 3390.20
M6
ParticipantsOG000148
ParticipantsOG001160
Title
Measurements
OG0001614.1± 2536.46
OG001
M12
ParticipantsOG000125
ParticipantsOG001138
Title
Measurements
OG0001482.4± 2387.88
OG001
M19
ParticipantsOG00059
ParticipantsOG00137
Title
Measurements
OG000956.6± 1806.72
OG001
M25
ParticipantsOG00059
ParticipantsOG00136
Title
Measurements
OG000840.4± 1706.07
OG001
% change at M6
ParticipantsOG000142
ParticipantsOG001145
Title
Measurements
OG000-29.9± 21.73
OG001
% change at M12
ParticipantsOG000120
ParticipantsOG001124
Title
Measurements
OG000-39.7± 21.83
OG001
% change at M19
ParticipantsOG00056
ParticipantsOG00135
Title
Measurements
OG000-48.9± 22.81
OG001
% change at M25
ParticipantsOG00054
ParticipantsOG00134
Title
Measurements
OG000-51.8± 20.81
OG001
Units
Counts
Participants
OG00081
OG00138
Title
Denominators
Categories
M3 after crossover
Title
Measurements
OG00049.4(38.1 to 60.7)
OG00128.9(15.4 to 45.9)
M6 after crossover
Title
Measurements
OG00043.2(32.2 to 54.7)
OG00131.6(17.5 to 48.7)
M9 after crossover
Title
Measurements
OG00054.3(42.9 to 65.4)
OG00131.6(17.5 to 48.7)
M12 after crossover
Title
Measurements
OG00044.4(33.4 to 55.9)
OG00123.7(11.4 to 40.2)
Units
Counts
Participants
OG00081
OG00138
Title
Denominators
Categories
M3 after crossover
Title
Measurements
OG00019.8(11.7 to 30.1)
OG0017.9(1.7 to 21.4)
M6 after crossover
Title
Measurements
OG00030.9(21.1 to 42.1)
OG0017.9(1.7 to 21.4)
M9 after crossover
Title
Measurements
OG00029.6(20.0 to 40.8)
OG00110.5(2.9 to 24.8)
M12 after crossover
Title
Measurements
OG00027.2(17.9 to 38.2)
OG0015.3(0.6 to 17.7)
Units
Counts
Participants
OG00081
OG00138
Title
Denominators
Categories
Ext. Baseline
ParticipantsOG00078
ParticipantsOG00133
Title
Measurements
OG0005.9± 15.02
OG0017.1± 9.80
M3 after crossover
ParticipantsOG00072
ParticipantsOG00136
Title
Measurements
OG0005.9± 19.70
OG001
M6 after crossover
ParticipantsOG00068
ParticipantsOG00132
Title
Measurements
OG0004.8± 14.51
OG001
M9 after crossover
ParticipantsOG00061
ParticipantsOG00132
Title
Measurements
OG0002.6± 3.03
OG001
M12 after crossover
ParticipantsOG00057
ParticipantsOG00129
Title
Measurements
OG0002.5± 2.47
OG001
Units
Counts
Participants
OG00081
OG00138
Title
Denominators
Categories
Ext. Baseline
ParticipantsOG00073
ParticipantsOG00132
Title
Measurements
OG0001420.9± 1914.58
OG0011809.6± 2579.25
Value at M6 after crossover
ParticipantsOG00065
ParticipantsOG00131
Title
Measurements
OG0001027.5± 1282.42
OG001
% change - M6 after crossover
ParticipantsOG00059
ParticipantsOG00127
Title
Measurements
OG000-18.1± 17.68
OG001
Value at M12 after crossover
ParticipantsOG00051
ParticipantsOG00130
Title
Measurements
OG000949.0± 1169.49
OG001
% change - M12 after crossover
ParticipantsOG00046
ParticipantsOG00126
Title
Measurements
OG000-24.7± 25.20
OG001
Units
Counts
Participants
OG00081
OG00138
Title
Denominators
Categories
Headache: Ext. BL
ParticipantsOG00081
ParticipantsOG00138
Title
Measurements
OG0000.6± 0.89
OG0010.4± 0.60
Headache: M12 after crossover
ParticipantsOG00060
ParticipantsOG00132
Title
Measurements
OG0000.5± 0.83
OG001
Fatigue: Ext. BL
ParticipantsOG00081
ParticipantsOG00138
Title
Measurements
OG0000.8± 1.07
OG001
Fatigue: M12 after crossover
ParticipantsOG00060
ParticipantsOG00132
Title
Measurements
OG0000.8± 0.91
OG001
Perspiration: Ext. BL
ParticipantsOG00081
ParticipantsOG00138
Title
Measurements
OG0000.5± 0.85
OG001
Perspiration: M12 after crossover
ParticipantsOG00060
ParticipantsOG00132
Title
Measurements
OG0000.6± 0.98
OG001
Paresthesia: Ext. BL
ParticipantsOG00081
ParticipantsOG00138
Title
Measurements
OG0000.4± 0.75
OG001
Paresthesia: M12 after crossover
ParticipantsOG00060
ParticipantsOG00132
Title
Measurements
OG0000.3± 0.56
OG001
Osteoarthralgia: Ext. BL
ParticipantsOG00081
ParticipantsOG00138
Title
Measurements
OG0000.6± 0.91
OG001
Osteoarthralgia: M12 after crossover
ParticipantsOG00060
ParticipantsOG00132
Title
Measurements
OG0000.5± 0.89
OG001
Units
Counts
Participants
OG00081
OG00138
Title
Denominators
Categories
Ext. BL LH 4th digit
ParticipantsOG00055
ParticipantsOG00126
Title
Measurements
OG00011.2± 2.10
OG00111.0± 1.87
Ext. BL LH 5th digit
ParticipantsOG0006
ParticipantsOG0015
Title
Measurements
OG00011.6± 1.88
OG001
Ext. BL RH 4th digit
ParticipantsOG00015
ParticipantsOG0017
Title
Measurements
OG00011.4± 2.42
OG001
Ext. BL RH 5th digit
ParticipantsOG0003
ParticipantsOG0010
Title
Measurements
OG00010.7± 2.31
M12 after CO LH 4th digit
ParticipantsOG00042
ParticipantsOG00124
Title
Measurements
OG00010.9± 2.27
OG001
M12 after CO LH 5th digit CO
ParticipantsOG0004
ParticipantsOG0014
Title
Measurements
OG00011.9± 2.14
OG001
M12 after CO RH 4th digit
ParticipantsOG00011
ParticipantsOG0014
Title
Measurements
OG00011.6± 2.95
OG001
M12 after CO RH 5th digit
ParticipantsOG0002
ParticipantsOG0010
Title
Measurements
OG00011.5± 0.00
Units
Counts
Participants
OG00081
OG00138
Title
Denominators
Categories
Ext. Baseline
ParticipantsOG00079
ParticipantsOG00134
Title
Measurements
OG00058.9± 23.11
OG00159.8± 22.40
M12 after crossover
ParticipantsOG00057
ParticipantsOG00130
Title
Measurements
OG00060.3± 24.34
OG001
Participants
OG00081
OG00138
Title
Denominators
Categories
Ext. Baseline
ParticipantsOG00078
ParticipantsOG00134
Title
Measurements
OG00011.9± 18.42
OG00115.7± 36.76
M12 after crossover
ParticipantsOG00060
ParticipantsOG00131
Title
Measurements
OG0007.5± 8.95
OG001
1 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
1 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
1 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0042 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0052 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0042 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0042 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0043 affected178 at risk
EG0050 affected81 at risk
1 affected
38 at risk
EG0045 affected178 at risk
EG0053 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
1 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0043 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
1 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0042 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
1 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0042 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0041 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
1 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
1 affected
38 at risk
EG00415 affected178 at risk
EG0053 affected81 at risk
2 affected
38 at risk
EG0040 affected178 at risk
EG0051 affected81 at risk
0 affected
38 at risk
EG00410 affected178 at risk
EG0050 affected81 at risk
2 affected
38 at risk
EG00421 affected178 at risk
EG0050 affected81 at risk
1 affected
38 at risk
EG00436 affected178 at risk
EG0054 affected81 at risk
0 affected
38 at risk
EG00414 affected178 at risk
EG0054 affected81 at risk
1 affected
38 at risk
EG00413 affected178 at risk
EG0055 affected81 at risk
6 affected
38 at risk
EG00472 affected178 at risk
EG00526 affected81 at risk
1 affected
38 at risk
EG0049 affected178 at risk
EG0054 affected81 at risk
0 affected
38 at risk
EG00411 affected178 at risk
EG0050 affected81 at risk
2 affected
38 at risk
EG0042 affected178 at risk
EG0052 affected81 at risk
2 affected
38 at risk
EG0041 affected178 at risk
EG0052 affected81 at risk
2 affected
38 at risk
EG00429 affected178 at risk
EG00510 affected81 at risk
1 affected
38 at risk
EG00422 affected178 at risk
EG0054 affected81 at risk
3 affected
38 at risk
EG00421 affected178 at risk
EG0057 affected81 at risk
1 affected
38 at risk
EG00414 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG00411 affected178 at risk
EG0052 affected81 at risk
1 affected
38 at risk
EG0045 affected178 at risk
EG0055 affected81 at risk
6 affected
38 at risk
EG00459 affected178 at risk
EG00523 affected81 at risk
2 affected
38 at risk
EG0048 affected178 at risk
EG0055 affected81 at risk
3 affected
38 at risk
EG00411 affected178 at risk
EG0056 affected81 at risk
0 affected
38 at risk
EG00413 affected178 at risk
EG0052 affected81 at risk
3 affected
38 at risk
EG00418 affected178 at risk
EG0054 affected81 at risk
7 affected
38 at risk
EG00434 affected178 at risk
EG00515 affected81 at risk
1 affected
38 at risk
EG0049 affected178 at risk
EG0053 affected81 at risk
2 affected
38 at risk
EG00420 affected178 at risk
EG0055 affected81 at risk
0 affected
38 at risk
EG00411 affected178 at risk
EG00510 affected81 at risk
0 affected
38 at risk
EG00416 affected178 at risk
EG0055 affected81 at risk
0 affected
38 at risk
EG00413 affected178 at risk
EG0055 affected81 at risk
1 affected
38 at risk
EG00411 affected178 at risk
EG0053 affected81 at risk
6 affected
38 at risk
EG00427 affected178 at risk
EG0058 affected81 at risk
0 affected
38 at risk
EG00418 affected178 at risk
EG0058 affected81 at risk
2 affected
38 at risk
EG0045 affected178 at risk
EG0051 affected81 at risk
4 affected
38 at risk
EG0048 affected178 at risk
EG0052 affected81 at risk
0 affected
38 at risk
EG00410 affected178 at risk
EG0052 affected81 at risk
0 affected
38 at risk
EG00410 affected178 at risk
EG0054 affected81 at risk
0 affected
38 at risk
EG0043 affected178 at risk
EG0052 affected81 at risk
0 affected
38 at risk
EG00412 affected178 at risk
EG0059 affected81 at risk
0 affected
38 at risk
EG0042 affected178 at risk
EG0055 affected81 at risk
2 affected
38 at risk
EG00411 affected178 at risk
EG0053 affected81 at risk
0 affected
38 at risk
EG0049 affected178 at risk
EG0055 affected81 at risk
3 affected
38 at risk
EG00440 affected178 at risk
EG00519 affected81 at risk
0 affected
38 at risk
EG0043 affected178 at risk
EG0055 affected81 at risk
1 affected
38 at risk
EG00410 affected178 at risk
EG0052 affected81 at risk
5 affected
38 at risk
EG00456 affected178 at risk
EG00529 affected81 at risk
2 affected
38 at risk
EG0045 affected178 at risk
EG0055 affected81 at risk
0 affected
38 at risk
EG0049 affected178 at risk
EG0052 affected81 at risk
2 affected
38 at risk
EG00414 affected178 at risk
EG0058 affected81 at risk
0 affected
38 at risk
EG00412 affected178 at risk
EG0054 affected81 at risk
2 affected
38 at risk
EG00424 affected178 at risk
EG00514 affected81 at risk
3 affected
38 at risk
EG00424 affected178 at risk
EG0058 affected81 at risk
1 affected
38 at risk
EG00410 affected178 at risk
EG0058 affected81 at risk
1 affected
38 at risk
EG0049 affected178 at risk
EG0052 affected81 at risk
2 affected
38 at risk
EG0044 affected178 at risk
EG0052 affected81 at risk
1 affected
38 at risk
EG00416 affected178 at risk
EG0056 affected81 at risk
4 affected
38 at risk
EG00422 affected178 at risk
EG0059 affected81 at risk
5 affected
38 at risk
EG00442 affected178 at risk
EG00520 affected81 at risk
1 affected
38 at risk
EG0049 affected178 at risk
EG0050 affected81 at risk
0 affected
38 at risk
EG00411 affected178 at risk
EG0052 affected81 at risk
1 affected
38 at risk
EG00412 affected178 at risk
EG0054 affected81 at risk
2 affected
38 at risk
EG0048 affected178 at risk
EG0052 affected81 at risk
2 affected
38 at risk
EG0040 affected178 at risk
EG0050 affected81 at risk
1 affected
38 at risk
EG00416 affected178 at risk
EG0053 affected81 at risk
1 affected
38 at risk
EG0049 affected178 at risk
EG0054 affected81 at risk
1 affected
38 at risk
EG00434 affected178 at risk
EG0054 affected81 at risk
3 affected
38 at risk
EG00421 affected178 at risk
EG0056 affected81 at risk
51.3
(39.7 to 62.8)
51.9
(41.9 to 61.8)
-38.0
± 24.47
2196.5
± 3922.08
-39.0
± 23.81
2308.1
± 2930.84
-37.2
± 25.07
-801.2
± 1676.62
-713.8
± 1708.20
-867.1
± 1661.24
26.9
(17.5 to 38.2)
21.2
(13.8 to 30.3)
19.8
(14.3 to 26.3)
23.1
(17.2 to 29.9)
17.6
(12.3 to 23.9)
12.4
(7.6 to 18.7)
13.7
(8.7 to 20.2)
16.3
(10.9 to 23.2)
13.7
(8.7 to 20.2)
5.8
± 12.87
5.2
± 10.99
4.3
± 9.70
4.5
± 11.34
1.4
± 1.49
1.5
± 1.68
1.4
± 1.43
1.2
± 1.11
1.4
± 1.23
1.3
± 1.31
0.8
± 1.15
1.3
± 1.26
0.6
± 0.79
0.7
± 0.99
0.5
± 0.91
0.4
± 0.72
0.7
± 1.00
0.6
± 0.77
0.7
± 0.89
0.4
± 0.67
0.4
± 0.67
0.8
± 1.07
12.4
± 2.88
11.4
± 2.54
11.3
± 2.95
11.1
± 1.95
12.4
± 1.78
11.3
± 2.18
10.5
± 2.14
11.1
± 1.95
14.3
± 0.35
10.9
± 1.65
7.5
± NA
N/A = Not applicable for Std. Dev.
61.6
± 21.01
62.9
± 18.86
11.7
± 19.09
6.7
± 4.63
2.88
± 1.371
OG0017.81± 3.505
3.39
± 2.659
OG0018.70± 5.402
3.93
± 1.858
OG0019.51± 5.487
OG00213.48± 7.750
5.22
± 4.077
OG00110.92± 6.017
OG00213.42± 6.902
2.87
± 1.101
OG00110.59± 6.216
OG00213.08± 6.967
2.29
± 0.857
OG00111.85± 7.781
OG00214.76± 6.868
3.65
± 1.865
OG00112.33± 7.619
OG00215.88± 9.073
4.80
± 1.957
OG00112.75± 8.604
OG00216.03± 10.852
5.66
± 3.606
OG00112.42± 7.252
OG00216.01± 11.497
5.10
± 2.375
OG00112.62± 6.920
OG00216.31± 10.596
4.54
± 1.634
OG00111.11± 6.489
OG00216.16± 9.323
0.61
± 0.280
OG0011.21± 0.663
0.62
± 0.107
OG0011.29± 0.654
0.19
± NA
N/A = Insufficient number of participants to calculate standard deviation.
OG0011.45± 0.653
OG0021.55± 0.658
1.65
± 0.876
OG0022.14± 1.156
1.33
± 0.754
OG0011.58± 0.811
OG0022.12± 0.990
0.70
± NA
N/A = Insufficient number of participants to calculate standard deviation.
OG0011.46± 0.704
OG0022.14± 1.009
1.55
± 0.727
OG0022.16± 1.127
1.74
± 1.013
OG0022.20± 0.992
1.66
± 0.995
OG0022.50± 1.194
1.74
± 0.890
OG0022.39± 1.103
0.30
± NA
N/A = Insufficient number of participants to calculate standard deviation.