Study of Telotristat Etiprate (LX1606) in Participants Wi... | NCT00853047 | Trialant
NCT00853047
Sponsor
Lexicon Pharmaceuticals
Status
Completed
Last Update Posted
Dec 26, 2018Actual
Enrollment
23Actual
Phase
Phase 2
Conditions
Carcinoid Syndrome
Interventions
Telotristat etiprate
Octreotide LAR Depot
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00853047
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
LX1606.1-202-CS
Secondary IDs
ID
Type
Description
Link
LX1606.202
Other Identifier
Lexicon Pharmaceuticals, Inc.
Brief Title
Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy
Official Title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Ascending, Multidose Study To Determine Safety and Tolerability of Orally Administered LX1606 in Subjects With Symptomatic Carcinoid Syndrome Refractory to Stable-Dose Octreotide Long-Acting Release Depot Therapy
Acronym
Not provided
Organization
Lexicon PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
Oct 2018
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
Mar 2009
Primary Completion Date
Jun 2014Actual
Completion Date
Jun 2014Actual
First Submitted Date
Feb 25, 2009
First Submission Date that Met QC Criteria
Feb 25, 2009
First Posted Date
Feb 27, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 27, 2017
Results First Submitted that Met QC Criteria
Dec 3, 2018
Results First Posted Date
Dec 26, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 4, 2016
Certification/Extension First Submitted that Passed QC Review
Feb 4, 2016
Certification/Extension First Posted Date
Mar 3, 2016Estimated
Last Update Submitted Date
Dec 3, 2018
Last Update Posted Date
Dec 26, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Lexicon PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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 purpose of this study is to evaluate the safety and tolerability of telotristat etiprate (LX1606) versus a placebo control in participants with symptomatic carcinoid syndrome not managed by stable-dose long-acting octreotide therapy. Following determination of the maximally tolerated or effective dose, cohort expansion will occur to confirm effect on symptoms and safety profile.
Detailed Description
Not provided
Conditions Module
Conditions
Carcinoid Syndrome
Keywords
Not provided
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
23Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Telotristat Etiprate 150 mg Core Phase
Experimental
Telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Drug: Telotristat etiprate
Drug: Octreotide LAR Depot
Telotristat Etiprate 250 mg Core Phase
Experimental
Telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Drug: Telotristat etiprate
Drug: Octreotide LAR Depot
Telotristat Etiprate 350 mg Core Phase
Experimental
Telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Drug: Telotristat etiprate
Drug: Octreotide LAR Depot
Telotristat Etiprate 500 mg Core Phase
Experimental
Telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Telotristat etiprate
Drug
Telotristat etiprate capsules; orally 3 times daily.
Telotristat Etiprate 150 mg Core Phase
Telotristat Etiprate 250 mg Core Phase
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Drug-related TEAE in the Core Phase
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.
Up to 4 Weeks Core Phase
Number of Participants With Any TEAE in the Open-Label Extension Phase
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after receiving treatment.
Up to 180 weeks in the open-label extension phase
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Mean Number of Bowel Movements (BMs) Per Day
Participants recorded the number of BMs per day in a daily diary. The total number of BMs per day were averaged over the 4-week period. A negative change from Baseline indicates improvement.
Baseline to Week 4
Change From Baseline in Weekly Mean Stool Form
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Males and females, aged 18 and older
Biopsy-proven metastatic carcinoid tumor of the gastrointestinal (GI) tract with disease extent confirmed by computed tomography (CT), magnetic resonance imaging (MRI), or radionuclide imaging
Symptoms not managed by stable-dose long-acting octreotide therapy (≥4 bowel movements per day)
Ability to provide written informed consent
Exclusion Criteria:
≥12 high volume, watery bowel movements per day associated with a clinical syndrome of volume contraction, dehydration, or hypotension compatible with a "pancreatic cholera"-type clinical syndrome
Sponsor-unacceptable clinical laboratory values for hematology and liver function tests at screening
Karnofsky status ≤70% - unable to care for self
Surgery within 60 days prior to screening
A history of short bowel syndrome
Life expectancy <12 months
History of substance or alcohol abuse within 2 years prior to screening
Previous exposure to a tryptophan hydroxylase (TPH) inhibitor
Administration of any investigational drug within 30 days of screening or any therapeutic protein or antibody within 90 days of screening
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
Pablo Lapuerta, MD
Lexicon Pharmaceuticals, Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Hematology Oncology Services of Arkansas
Little Rock
Arkansas
72205
United States
UCSF Helen Diller Family Comprehensive Cancer Center
Gelhorn HL, Kulke MH, O'Dorisio T, Yang QM, Jackson J, Jackson S, Boehm KA, Law L, Kostelec J, Auguste P, Lapuerta P. Patient-reported Symptom Experiences in Patients With Carcinoid Syndrome After Participation in a Study of Telotristat Etiprate: A Qualitative Interview Approach. Clin Ther. 2016 Apr;38(4):759-68. doi: 10.1016/j.clinthera.2016.03.002. Epub 2016 Mar 31.
A total of 23 participants were enrolled in the Core Phase (ie, Screening and Double-blind Treatment Period) from 11 sites, including 1 satellite site, in the United States. 19 participants entered the Open-label Extension Phase.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo Core Phase
Participants received placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
Periods
Title
Milestones
Reasons Not Completed
Core Phase
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
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
Not provided
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
ParticipantInvestigatorOutcomes Assessor
Drug: Telotristat etiprate
Drug: Octreotide LAR Depot
Placebo Core Phase
Experimental
Placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
Drug: Octreotide LAR Depot
Drug: Placebo
Telotristat Etiprate Open-Label Extension Phase
Experimental
Telotristat etiprate at assigned dose level for 8 weeks in combination with stable-dose octreotide LAR depot therapy given once per month in the open-label extension period. Upon completion of the 8-week period, participants could enter an additional extension period of 172 weeks, receiving telotristat etiprate at the assigned dose or maximum tolerated dose (500 mg 3 times daily).
Drug: Telotristat etiprate
Drug: Octreotide LAR Depot
Telotristat Etiprate 350 mg Core Phase
Telotristat Etiprate 500 mg Core Phase
Telotristat Etiprate Open-Label Extension Phase
LX1606
Octreotide LAR Depot
Drug
A stable-dose octreotide LAR depot therapy; administered subcutaneously once per month.
Placebo Core Phase
Telotristat Etiprate 150 mg Core Phase
Telotristat Etiprate 250 mg Core Phase
Telotristat Etiprate 350 mg Core Phase
Telotristat Etiprate 500 mg Core Phase
Telotristat Etiprate Open-Label Extension Phase
Placebo
Drug
Placebo-matching telotristat etiprate capsules; orally 3 times daily.
Placebo Core Phase
Participants recorded stool form in a daily diary using a 6-point scale (0-none,1-hard, 2-firm, 3-soft, 4-loose, 5-watery). A negative change from Baseline indicates improvement.
Baseline to Week 4
Change From Baseline in Percentage of Days Per Week Experiencing a Sensation of Urgency to Defecate
Participants recorded the sensation of urgency to defecate (Yes or No) in a daily diary. A negative change from Baseline indicates improvement.
Baseline to Week 4
Change From Baseline in Number of Cutaneous Flushing Episodes
Participants recorded the number of daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 4-week period. A negative change from Baseline indicates improvement.
Baseline to Week 4
Change From Baseline in Severity of Abdominal Pain or Discomfort
Participants recorded the severity of abdominal pain or discomfort in a daily diary assessed using a 4-point scale (0-none, 1-mild, 2-moderate, 3-severe). A negative change from Baseline indicates improvement.
Baseline to Week 4
Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA)
u5-HIAA is a standard test used in clinical practice to assess the neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. A negative change from Baseline indicates improvement.
Baseline to Week 4
Change From Baseline in Chromogranin A
Blood samples were collected for assessment of Chromogranin A level. A negative change from Baseline indicates improvement.
Baseline to Week 4
Number of Participants Reporting Improvement in the Subjective Global Assessment of Symptoms Associated With Carcinoid Syndrome
Participants were asked to answer the following question: "In the past 7 days, have you had adequate relief of your carcinoid syndrome bowel complaints such as diarrhea, urgent need to have a bowel movement, abdominal pain, or discomfort?". The number of participants who answered Yes are reported.
Week 4
Change From Baseline in Frequency of Rescue for Short-acting Octreotide Use/Day
Participants recorded details (location and frequency of injection) of subcutaneous injections of rescue, short-acting octreotide, if taken, in the daily diary. A negative change from Baseline indicates improvement.
Baseline to Week 4
Time to First Rescue, Short-acting Octreotide
Time to the first subcutaneous injections of rescue, short-acting octreotide was determined from the participant's daily diary.
Baseline to Week 4
Number of Participants Experiencing Complete Response at Week 4
Complete Response to treatment was defined as one of the following: 1. Less than 4 bowel movements per day; or 2. A decrease in daily bowel movements that is ≥ 50% from baseline; or 3. A positive response to the global assessment question ("In the past 7 days, have you had adequate relief of your carcinoid syndrome bowel complaints such as diarrhea, urgent need to have a bowel movement, abdominal pain or discomfort?") for each of the last 2 weeks of the Treatment Period.
Baseline to Week 4
San Francisco
California
94115
United States
St. Francis Medical Group Oncology and Hematology Specialists
Indianapolis
Indiana
46237
United States
University of Iowa
Iowa City
Iowa
52242
United States
Dana Farber Cancer Institute
Boston
Massachusetts
02115
United States
Nebraska Methodist Hospital
Omaha
Nebraska
68114
United States
UT M.D. Anderson Cancer Center
Houston
Texas
77030
United States
Texas Oncology - McAllen
McAllen
Texas
78503
United States
Texas Oncology - Weslaco
Weslaco
Texas
78596
United States
Derived
Kulke MH, O'Dorisio T, Phan A, Bergsland E, Law L, Banks P, Freiman J, Frazier K, Jackson J, Yao JC, Kvols L, Lapuerta P, Zambrowicz B, Fleming D, Sands A. Telotristat etiprate, a novel serotonin synthesis inhibitor, in patients with carcinoid syndrome and diarrhea not adequately controlled by octreotide. Endocr Relat Cancer. 2014 Oct;21(5):705-14. doi: 10.1530/ERC-14-0173. Epub 2014 Jul 10.
FG001
Telotristat Etiprate 150 mg Core Phase
Participants received telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
FG002
Telotristat Etiprate 250 mg Core Phase
Participants received telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
FG003
Telotristat Etiprate 350 mg Core Phase
Participants received telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
FG004
Telotristat Etiprate 500 mg Core Phase
Participants received telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
FG005
Telotristat Etiprate Open-Label Extension Phase
Participants received telotristat etiprate at assigned dose level for 8 weeks in combination with stable-dose octreotide LAR depot therapy given once per month in the open-label extension period. Upon completion of the 8-week period, participants could enter an additional extension period of 172 weeks, receiving telotristat etiprate at the assigned dose or maximum tolerated dose (500 mg 3 times daily).
FG0005 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0049 subjects
FG0050 subjects
COMPLETED
FG0005 subjects
FG0013 subjects
FG0023 subjects
FG0032 subjects
FG0049 subjects
FG0050 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Participant Request
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Open-Label Extension Phase
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00519 subjects19 of the 22 participants who completed the Core Phase entered the optional Open-Label Extension.
Completed 8-week Extension Period
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Participant Request
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The Safety Set, Core Phase included all participants who received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo Core Phase
Participants received placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
BG001
Telotristat Etiprate 150 mg Core Phase
Participants received telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
BG002
Telotristat Etiprate 250 mg Core Phase
Participants received telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
BG003
Telotristat Etiprate 350 mg Core Phase
Participants received telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
BG004
Telotristat Etiprate 500 mg Core Phase
Participants received telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0005
BG0013
BG0023
BG0033
BG0049
BG00523
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
BG00062.4± 11.72
BG00151.7± 8.08
BG00261.0± 16.09
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0013
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
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
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Drug-related TEAE in the Core Phase
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.
The Safety Set Core Phase included all participants who received at least one dose of study drug in the core phase.
Posted
Count of Participants
Participants
Up to 4 Weeks Core Phase
ID
Title
Description
OG000
Placebo Core Phase
Participants received placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
OG001
Telotristat Etiprate 150 mg Core Phase
Participants received telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG002
Telotristat Etiprate 250 mg Core Phase
Participants received telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG003
Telotristat Etiprate 350 mg Core Phase
Participants received telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG004
Telotristat Etiprate 500 mg Core Phase
Participants received telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Units
Counts
Participants
OG0005
OG0013
OG0023
OG003
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG0004
OG0013
OG0023
OG003
Primary
Number of Participants With Any TEAE in the Open-Label Extension Phase
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after receiving treatment.
The Safety Set Extension Period included all participants who received at least one dose of study drug in the open-label extensions phase.
Posted
Count of Participants
Participants
Up to 180 weeks in the open-label extension phase
ID
Title
Description
OG000
Telotristat Etiprate Open-Label Extension Phase
Participants received telotristat etiprate at assigned dose level for 8 weeks in combination with stable-dose octreotide LAR depot therapy given once per month in the open-label extension period. Upon completion of the 8-week period, participants could enter an additional extension period of 172 weeks, receiving telotristat etiprate at the assigned dose or maximum tolerated dose (500 mg 3 times daily).
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Mean Number of Bowel Movements (BMs) Per Day
Participants recorded the number of BMs per day in a daily diary. The total number of BMs per day were averaged over the 4-week period. A negative change from Baseline indicates improvement.
Participants from the modified Intent to Treat (mITT) Set, Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, with data available for analysis.
Posted
Mean
Standard Deviation
bowel movements/day
Baseline to Week 4
ID
Title
Description
OG000
Placebo Core Phase
Participants received placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
OG001
Telotristat Etiprate 150 mg Core Phase
Participants received telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Secondary
Change From Baseline in Weekly Mean Stool Form
Participants recorded stool form in a daily diary using a 6-point scale (0-none,1-hard, 2-firm, 3-soft, 4-loose, 5-watery). A negative change from Baseline indicates improvement.
Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, with data available for analysis.
Posted
Mean
Standard Deviation
units on a scale
Baseline to Week 4
ID
Title
Description
OG000
Placebo Core Phase
Participants received placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
OG001
Telotristat Etiprate 150 mg Core Phase
Participants received telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Secondary
Change From Baseline in Percentage of Days Per Week Experiencing a Sensation of Urgency to Defecate
Participants recorded the sensation of urgency to defecate (Yes or No) in a daily diary. A negative change from Baseline indicates improvement.
Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug with data available for analysis.
Posted
Mean
Standard Deviation
percentage of days
Baseline to Week 4
ID
Title
Description
OG000
Placebo Core Phase
Participants received placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
OG001
Telotristat Etiprate 150 mg Core Phase
Participants received telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Secondary
Change From Baseline in Number of Cutaneous Flushing Episodes
Participants recorded the number of daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 4-week period. A negative change from Baseline indicates improvement.
Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, with data available for analysis.
Posted
Mean
Standard Deviation
cutaneous flushing episodes
Baseline to Week 4
ID
Title
Description
OG000
Placebo Core Phase
Participants received placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
OG001
Telotristat Etiprate 150 mg Core Phase
Participants received telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Secondary
Change From Baseline in Severity of Abdominal Pain or Discomfort
Participants recorded the severity of abdominal pain or discomfort in a daily diary assessed using a 4-point scale (0-none, 1-mild, 2-moderate, 3-severe). A negative change from Baseline indicates improvement.
Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, with data available for analysis. Last Observation Carried Forward (LOCF)
Posted
Mean
Standard Deviation
units on a scale
Baseline to Week 4
ID
Title
Description
OG000
Placebo Core Phase
Participants received placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
OG001
Telotristat Etiprate 150 mg Core Phase
Participants received telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Secondary
Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA)
u5-HIAA is a standard test used in clinical practice to assess the neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. A negative change from Baseline indicates improvement.
Participants from the Pharmacodynamic (PD) Analysis Set Core Phase, all participants who received any fraction of a dose of study drug and had a valid Baseline and at least 1 valid post-Baseline PD assessment, with data available for analysis.
Posted
Mean
Standard Deviation
mg/24 hours
Baseline to Week 4
ID
Title
Description
OG000
Placebo Core Phase
Participants received placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
OG001
Telotristat Etiprate 150 mg Core Phase
Participants received telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Secondary
Change From Baseline in Chromogranin A
Blood samples were collected for assessment of Chromogranin A level. A negative change from Baseline indicates improvement.
Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, with data available for analysis.
Posted
Mean
Standard Deviation
ng/mL
Baseline to Week 4
ID
Title
Description
OG000
Placebo Core Phase
Participants received placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
OG001
Telotristat Etiprate 150 mg Core Phase
Participants received telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG002
Telotristat Etiprate 250 mg Core Phase
Secondary
Number of Participants Reporting Improvement in the Subjective Global Assessment of Symptoms Associated With Carcinoid Syndrome
Participants were asked to answer the following question: "In the past 7 days, have you had adequate relief of your carcinoid syndrome bowel complaints such as diarrhea, urgent need to have a bowel movement, abdominal pain, or discomfort?". The number of participants who answered Yes are reported.
Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, with data available for analysis.
Posted
Count of Participants
Participants
Week 4
ID
Title
Description
OG000
Placebo Core Phase
Participants received placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
OG001
Telotristat Etiprate 150 mg Core Phase
Participants received telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Secondary
Change From Baseline in Frequency of Rescue for Short-acting Octreotide Use/Day
Participants recorded details (location and frequency of injection) of subcutaneous injections of rescue, short-acting octreotide, if taken, in the daily diary. A negative change from Baseline indicates improvement.
Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, with data available for analysis.
Posted
Mean
Standard Deviation
injections per day
Baseline to Week 4
ID
Title
Description
OG000
Placebo Core Phase
Participants received placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
OG001
Telotristat Etiprate 150 mg Core Phase
Participants received telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Secondary
Time to First Rescue, Short-acting Octreotide
Time to the first subcutaneous injections of rescue, short-acting octreotide was determined from the participant's daily diary.
Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, As per protocol only the Placebo Core Phase and Telotristat Etiprate 500 mg Core Phase were included in the analysis.
Posted
Median
95% Confidence Interval
days
Baseline to Week 4
ID
Title
Description
OG000
Placebo Core Phase
Participants received placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
OG001
Telotristat Etiprate 500 mg Core Phase
Participants received telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Secondary
Number of Participants Experiencing Complete Response at Week 4
Complete Response to treatment was defined as one of the following: 1. Less than 4 bowel movements per day; or 2. A decrease in daily bowel movements that is ≥ 50% from baseline; or 3. A positive response to the global assessment question ("In the past 7 days, have you had adequate relief of your carcinoid syndrome bowel complaints such as diarrhea, urgent need to have a bowel movement, abdominal pain or discomfort?") for each of the last 2 weeks of the Treatment Period.
The mITT Set Core Phase included all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug.
Posted
Count of Participants
Participants
Baseline to Week 4
ID
Title
Description
OG000
Placebo Core Phase
Participants received placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
OG001
Telotristat Etiprate 150 mg Core Phase
Participants received telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Time Frame
Adverse event data was collected during the core phase over 4 weeks and up to 180 weeks in the extension phase
Description
Safety Set included all participants who received at least one dose of study drug.
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
Placebo Core Phase
Participants received placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
0
5
0
5
4
5
EG001
Telotristat Etiprate 150 mg Core Phase
Participants received telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
0
3
0
3
3
3
EG002
Telotristat Etiprate 250 mg Core Phase
Participants received telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
0
3
0
3
3
3
EG003
Telotristat Etiprate 350 mg Core Phase
Participants received telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
0
3
1
3
2
3
EG004
Telotristat Etiprate 500 mg Core Phase
Participants received telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
0
9
0
9
9
9
EG005
Telotristat Etiprate Open-Label Extension Phase
Participants received telotristat etiprate at assigned dose level for 8 weeks in combination with stable-dose octreotide LAR depot therapy given once per month in the open-label extension period. Upon completion of the 8-week period, participants could enter an additional extension period of 172 weeks, receiving telotristat etiprate at the assigned dose or maximum tolerated dose (500 mg 3 times daily).
1
19
8
19
18
19
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected9 at risk
EG0050 affected19 at risk
Vomiting
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Mass excision
Surgical and medical procedures
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Small intestinal resection
Surgical and medical procedures
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cholecystectomy
Surgical and medical procedures
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Disease progression
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Renal failure chronic
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pulmonary valve stenosis
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tricuspid valve incompetence
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0002 affected5 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG0030 affected3 at risk
EG0044 affected9 at risk
EG00510 affected19 at risk
Nausea
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 14.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Early satiety
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Flushing
Vascular disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Chest pain
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 14.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 14.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypokalemia
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pulmonary valve incompetence
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blepharitis
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Keratoconjunctivitis sicca
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Photophobia
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Visual impairment
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Malabsorption
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Steatorrhoea
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Chest discomfort
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Feeling cold
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Infusion site swelling
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Injection site haematoma
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Local swelling
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nodule
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cartilage injury
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cardiac murmur
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Weight increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Folate deficiency
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vitamin A deficiency
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vitamin E deficiency
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vitamin K deficiency
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Prostatomegaly
Reproductive system and breast disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Scrotal pain
Reproductive system and breast disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Apnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bronchitis chronic
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Orthopnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hot flush
Vascular disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastrointestinal hypermotility
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Feeling abnormal
General disorders
MedDRA 14.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood alkaline phophatase increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood glucose decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Low density lipoprotein increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Neutrophil count increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Protein total decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urine colour abnormal
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
White blood cell count increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Urine abnormality
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Scrotal oedema
Reproductive system and breast disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bilirubinuria
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oliguria
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Faecal incontinence
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected3 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
Institution must provide any proposed publication or presentation to Sponsor for Sponsor's review, comment and approval at least thirty (30) days prior to the proposed submission for publication date or the proposed presentation date. Sponsor shall have the right to have deleted from the final version of the publication any confidential information, proprietary information, or patentable subject matter.
Point of Contact
Title
Organization
Phone
Extension
Email
Pablo Lapuerta, MD
Lexicon Pharmaceuticals, Inc.
plapuerta@lexpharma.com
ID
Term
D020230
Serotonin Syndrome
Ancestor Terms
ID
Term
D064420
Drug-Related Side Effects and Adverse Reactions
D064419
Chemically-Induced Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000592493
telotristat
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG00516 subjects
0 subjects
FG0052 subjects
0 subjects
FG00517 subjects
0 subjects
FG0040 subjects
FG0057 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
Transfer to LX1606-302
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
Investigator Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
Reason Not Specified
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0056 subjects
52.7
± 9.81
BG00465.7± 9.94
BG00560.8± 11.39
1
BG0032
BG0044
BG00512
Male
BG0003
BG0010
BG0022
BG0031
BG0045
BG00511
0
BG0030
BG0040
BG0050
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Black or African American
BG0000
BG0011
BG0020
BG0030
BG0040
BG0051
White
BG0005
BG0012
BG0023
BG0033
BG0049
BG00522
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
3
OG0049
2
OG0049
Related TEAEs
Title
Measurements
OG0003
OG0013
OG0020
OG0032
OG0046
19
Title
Denominators
Categories
Title
Measurements
OG00018
OG002
Telotristat Etiprate 250 mg Core Phase
Participants received telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG003
Telotristat Etiprate 350 mg Core Phase
Participants received telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG004
Telotristat Etiprate 500 mg Core Phase
Participants received telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0031
OG0047
Title
Denominators
Categories
Title
Measurements
OG0000.82± 0.435
OG001-1.37± 1.514
OG002-2.17± 2.259
OG003-0.20± 0
OG004-0.71± 2.048
OG002
Telotristat Etiprate 250 mg Core Phase
Participants received telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG003
Telotristat Etiprate 350 mg Core Phase
Participants received telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG004
Telotristat Etiprate 500 mg Core Phase
Participants received telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Units
Counts
Participants
OG0004
OG0013
OG0022
OG0031
OG0047
Title
Denominators
Categories
Title
Measurements
OG000-0.07± 0.222
OG001-0.50± 0.755
OG0020.00± 0.141
OG0030.00± 0
OG004-0.17± 0.579
OG002
Telotristat Etiprate 250 mg Core Phase
Participants received telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG003
Telotristat Etiprate 350 mg Core Phase
Participants received telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG004
Telotristat Etiprate 500 mg Core Phase
Participants received telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0031
OG0047
Title
Denominators
Categories
Title
Measurements
OG000-2.72± 5.164
OG001-34.43± 47.261
OG002-32.13± 28.328
OG0030.00± 0
OG004-8.49± 15.742
OG002
Telotristat Etiprate 250 mg Core Phase
Participants received telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG003
Telotristat Etiprate 350 mg Core Phase
Participants received telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG004
Telotristat Etiprate 500 mg Core Phase
Participants received telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0031
OG0047
Title
Denominators
Categories
Title
Measurements
OG000-0.43± 0.435
OG001-0.60± 1.044
OG002-0.30± 0.436
OG003-0.10± 0
OG004-0.03± 0.673
OG002
Telotristat Etiprate 250 mg Core Phase
Participants received telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG003
Telotristat Etiprate 350 mg Core Phase
Participants received telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG004
Telotristat Etiprate 500 mg Core Phase
Participants received telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Units
Counts
Participants
OG0005
OG0013
OG0023
OG0033
OG0048
Title
Denominators
Categories
Title
Measurements
OG0000.04± 0.358
OG0010.03± 0.586
OG002-0.53± 0.808
OG0030.03± 0.153
OG0040.16± 0.358
OG002
Telotristat Etiprate 250 mg Core Phase
Participants received telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG003
Telotristat Etiprate 350 mg Core Phase
Participants received telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG004
Telotristat Etiprate 500 mg Core Phase
Participants received telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Units
Counts
Participants
OG0004
OG0012
OG0023
OG0032
OG0048
Title
Denominators
Categories
Title
Measurements
OG000-20.73± 17.212
OG001-27.55± 45.891
OG002-0.67± 0.493
OG00313.60± 19.092
OG004-35.49± 49.949
Participants received telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG003
Telotristat Etiprate 350 mg Core Phase
Participants received telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG004
Telotristat Etiprate 500 mg Core Phase
Participants received telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Units
Counts
Participants
OG0005
OG0012
OG0023
OG0032
OG0048
Title
Denominators
Categories
Title
Measurements
OG000-3251.2± 7803.84
OG001-190.5± 225.57
OG002-12.3± 13.05
OG00352.5± 60.10
OG00426011.4± 59383.95
OG002
Telotristat Etiprate 250 mg Core Phase
Participants received telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG003
Telotristat Etiprate 350 mg Core Phase
Participants received telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG004
Telotristat Etiprate 500 mg Core Phase
Participants received telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Units
Counts
Participants
OG0004
OG0012
OG0023
OG0032
OG0047
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0022
OG0031
OG0043
OG002
Telotristat Etiprate 250 mg Core Phase
Participants received telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG003
Telotristat Etiprate 350 mg Core Phase
Participants received telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG004
Telotristat Etiprate 500 mg Core Phase
Participants received telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0031
OG0047
Title
Denominators
Categories
Title
Measurements
OG000-0.38± 0.695
OG001-0.03± 0.058
OG0020.03± 0.058
OG0030.00± 0
OG004-0.29± 0.669
Units
Counts
Participants
OG0005
OG0019
Title
Denominators
Categories
Title
Measurements
OG0001.00(1.00 to NA)The upper limit of 95% Confidence Interval was not obtained due to the low number of participants with events.
OG0011.00(1.00 to NA)The upper limit of 95% Confidence Interval was not obtained due to the low number of participants with events.
OG002
Telotristat Etiprate 250 mg Core Phase
Participants received telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG003
Telotristat Etiprate 350 mg Core Phase
Participants received telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
OG004
Telotristat Etiprate 500 mg Core Phase
Participants received telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.